FDA Limits Acetaminophen in Prescription Combination Products; Requires Liver Toxicity Warnings

/PRNewswire/ -- The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Acetaminophen, also called APAP, is a drug that relieves pain and fever. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER). "Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death."

The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication. Patients and health care professionals are being notified of the new limitation on acetaminophen content, and of the labeling change, in a drug safety communication issued by CDER. The FDA believes that prescription combination products containing no more than 325 mg of acetaminophen per tablet are effective for treating pain.

"There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider," said Kweder. "The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period."

Acetaminophen also is widely used as an over-the-counter pain and fever medication, and is combined with other OTC ingredients, such as cough and cold ingredients. The actions FDA is taking for prescription acetaminophen products do not affect OTC acetaminophen products.

Because of continued reports of liver injury, FDA proposes that boxed warnings, the agency's strongest warning for prescription drugs, be added to all acetaminophen prescription products. Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products.

An FDA advisory committee discussed the issue at a meeting in June, 2009, and recommended strengthening the warning about severe liver injury on the drug labels of prescription products containing acetaminophen.

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FDA issues warnings to marketers of unapproved ‘chelation’ products

The U.S. Food and Drug Administration today warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.

The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.

The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.

In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.

“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”

The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.

The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.

Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.

"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness.” said Dara A. Corrigan, associate commissioner for Regulatory Affairs.

Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and provide data that demonstrate their products’ safety and effectiveness.

The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction. The FDA issued warning letters to the following companies:

* World Health Products, LLC: Detoxamin Oral, Detoxamin Suppositories, and the Metal Detector test kit
* Hormonal Health, LLC and World Health Products, LLC: Kelatox Suppositories, and the METALDETECTOR Instant Toxic Metals Test
* Evenbetternow, LLC: Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, and the Heavy Metal Screen Test
* Maxam Nutraceutics/Maxam Laboratories: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the Heavy Metal Screening Test
* Cardio Renew, Inc: CardioRenew and CardioRestore
* Artery Health Institute, LLC: Advanced Formula EDTA Oral Chelation
* Longevity Plus: Beyond Chelation Improved, EndoKinase, Viral Defense, Wobenzym-N
* Dr. Rhonda Henry: Cardio Chelate (H-870)

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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FDA: Possible increased risk of thigh bone fracture with bisphosphonates

The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.

Bisphosphonates inhibit the loss of bone mass in people with osteoporosis. Bisphosphonates have been shown to reduce the rate of osteoporotic fractures -- fractures that can result in pain, hospitalization, and surgery-- in people with osteoporosis. While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.

The labeling changes and Medication Guide will affect only those bisphosphonates approved for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and their generic products, as well as injectable bisphosphonates such as Reclast and Boniva.

Labeling changes and the Medication Guide will not apply to bisphosphonates used for Paget’s disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic products.

“The FDA is continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment,” said RADM Sandra Kweder, M.D., deputy director, Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. "In the interim, it’s important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.”

Today’s warning follows a March 10, 2010, Drug Safety Communication announcing the FDA’s ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has since reviewed all available data on bisphosphonate use, including data summarized in the American Society for Bone Mineral Research Task Force report. The report recommended additional product labeling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures.

Based on the FDA’s review, the Warnings and Precautions section of all bisphosphonate products for osteoporosis will be revised, and the FDA will require the inclusion of a Medication Guide to better inform patients of the possible increased fracture risk.

The FDA recommends that health care professionals be aware of the possible risk in patients taking bisphosphonates and consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.

Patients taking bisphosphonates for osteoporosis should not stop using their medication unless told to do so by their health care professional. Those taking bisphosphonates also should report any new thigh or groin pain to their health care provider and be evaluated for a possible femur fracture. Patients and health care professionals should report side effects with the use of bisphosphonates to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling (800) 332-1088.

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Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk

FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.

The agency recently became aware that an independent U.S. academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline. PCV1 is not known to cause illness in humans or other animals. In addition, Rotarix has been studied extensively, before and after approval, and found to have an excellent safety record.

Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the academic team’s findings and confirmed that viral components have been present since the early stages of the vaccine’s development, including during clinical studies. Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1.

"We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. “There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. We will keep the public and the clinical community updated on our findings.”

Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration and is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries. Before the introduction of a rotavirus vaccine, rotavirus resulted in more than 50,000 hospitalizations and several dozen deaths in the United States each year. FDA licensed RotaTeq in 2006 and Rotarix in 2008. Most children vaccinated in the United States received RotaTeq.

“In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine,” said Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention. “We anticipate that many countries will decide to continue vaccinating with Rotarix while more information becomes known.”

FDA will continue to gather more information about the PCV1 components in Rotarix, including whether intact virus, as opposed to DNA fragments, is present. The agency is assessing current vaccine testing methods. In four to six weeks, FDA will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines.

FDA will provide updates to patients, providers, and the general public as more information becomes available. The agency will also continue to communicate with the World Health Organization and counterpart regulatory agencies in other countries.

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FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma

The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

These new requirements are based on FDA analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma. The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids. These medications improve a patient’s ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung’s airways.

The FDA will now require that the product labels reflect the following:

* The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone;
* LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
* LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
* Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research.

“The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone,” said Dianne Murphy, M.D., director of the FDA’s Office of Pediatric Therapeutics.

LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices.

“We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don’t adjust, we will determine the reasons and consider additional steps to support safe prescribing,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
Foradil is marketed by Lebanon, PA-based Novartis AG.
Symbicort is marketed by Wilmington, DE-based AstraZeneca.

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FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC

Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17.

New data suggest that when patients take both Prilosec and Plavix, Plavix’s ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.

“Both of these drugs, when used properly, provide significant benefits to patients.” said Mary Ross Southworth, Pharm.D., of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “However, patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec.”

Plavix is used to prevent blood clots that could lead to heart attacks or strokes in at-risk patients. Omeprazole, the active ingredient of Prilosec and Prilosec OTC, is a proton pump inhibitor (PPI) used to reduce the production of stomach acid and prevent stomach irritation.

Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme, CYP2C19. Prilosec blocks this enzyme, thereby reducing the effectiveness of Plavix.

After issuing an Early Communication in January about possible drug interactions involving Plavix, the FDA requested new studies from the drug’s manufacturers, sanofi-aventis and Bristol-Myers-Squibb. These new studies support the existence of a significant interaction that could negatively impact a person’s health. Based on the current scientific information, the Plavix label has been updated with new warnings about the use of Prilosec and other drugs that inhibit the CYP2C19 enzyme and that could interact with Plavix in the same way.

The new studies compared people who took Plavix and Prilosec together with people who took Plavix alone. A reduction in Plavix’s anti-clotting effect was found in those individuals who took the combination. Similar results were seen irrespective of whether the two drugs were taken at the same or different times of day.

It is unknown how other PPIs may interfere with Plavix. Other drugs that should not be used with Plavix because they may have a similar interaction with CYP2C19 include Nexium (esomeprazole), Tagamet and Tagamet HB (cimetidine), Diflucan (fluconazole), Nizoral (ketoconazole), VFEND (voriconazole), Intelence (etravirine), Felbatol (felbamate), Prozac, Serafem, Symbyax (fluoxetine), Luvox (fluvoxamine) and Ticlid (ticlopidine).

Patients who take Plavix and need to take a drug to reduce stomach acid should discuss their therapy with a health care professional. Zantac (ranitidine), Pepcid (famotidine), Axid (nizatidine), and antacids do not inhibit the CYP2C19 enzyme and aren’t expected to interfere with the anti-clotting activity of Plavix.

Plavix’s manufacturers have agreed to continue conducting studies to explore this and other drug interactions. When the FDA has reviewed additional data, the agency will communicate any new recommendations or conclusions.

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FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C

The U.S. Food and Drug Administration yesterday sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:

* To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and
* Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.

The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.

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FDA Announces Plans for LASIK Quality of Life Project

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

“This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure,” said Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

“Many people in the U.S. undergo LASIK procedures,” said Shuren. “Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements.”

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FDA Warns Consumers Not to Use Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)

* Lot number 9G04, NDC # 49502-697-29
* Lot number 9FD8, NDC # 49502-697-61
* Lot number 9FD9, NDC # 49502-697-61
* Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)

* Lot number F09089, NDC # 49502-685-31
* Lot number C09119, NDC # 49502-685-62
* Lot number C09120, NDC # 49502-685-62

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

The FDA is asking for the public's help in reporting any information regarding the stolen Dey products to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

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FDA: Cancer Warnings Required for TNF Blockers

The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases.

In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

Today’s action is based on the completion of an investigation first announced by the FDA in June 2008. An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.

Additional required updates to the prescribing information include incorporation of reports of psoriasis associated with the use of TNF blockers.

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FDA Warns Consumers Not to Use Body Building Products Marketed as Containing Steroids or Steroid-Like Substances

The U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

The agency also issued a Warning Letter to American Cellular Laboratories Inc. for marketing and distributing body building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.

The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA is taking enforcement action today to protect the public.”

The products listed in the Warning Letter to American Cellular Laboratories Inc., include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective. In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Consumers should also consult a health care professional if they suspect they are experiencing problems associated with the products. Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug

The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU) for the treatment of Graves' disease.

"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

PTU was approved for marketing in 1947. A total of 32 cases of serious liver injury associated with the use of PTU were reported to the FDA's Adverse Event Reporting System since that system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant.

Graves’ disease is an autoimmune disorder that leads to overactivity of the thyroid gland. The thyroid gland, located in the front of the neck just below the Adam’s Apple, releases hormones that regulate the rate of the body’s metabolism and are critical for body temperature control, energy, weight, mood, and blood calcium levels.

PTU is considered second-line drug therapy, except in certain patients who are allergic to, or intolerant of, methimazole. Because a rare birth defect has been reported with methimazole and not with PTU, PTU may be more appropriate for patients with Graves’ disease who are in the first trimester of pregnancy.

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FDA Warns Consumers to Stop Using Hydroxycut Products

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

–Online: www.fda.gov/MedWatch/report.htm
–Regular Mail: Use FDA postage paid form 3500 found at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
–Fax: 800-FDA-0178
–Phone: 800-FDA-1088

The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

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FDA Warns About Risk of Wearing Medicated Patches During MRIs

Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.

The patches of concern include both brand name and generic products and patches purchased over the counter without a prescription.

The FDA issued the Public Health Advisory on transdermal drug patches after learning that a warning was missing on some patches that contain aluminum or other metals in their non-adhesive backing. The backing is the portion of the patch not in direct contact with the skin.

While not attracted to the magnetic field of the MRI, the metal can conduct electricity, generating heat which can cause burns. Users of the patches reported receiving skin burns at their patch site when wearing the patch during an MRI scan.

"The risk of using a metallic patch during an MRI has been well-established, but the FDA recently discovered that not all manufacturers include a safety warning with their patches," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because the metal in these patches may not be visible and the product labeling may not disclose the presence of metal, patients should tell both their health care professional and their MRI facility that they wear a medicated adhesive patch."

The FDA was alerted to the missing MRI warning on Teva Pharmaceutical's fentanyl transdermal system in January. The FDA investigated and found that a similar warning was also missing on a variety of skin, or transdermal, patches delivering medications.

The FDA is reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning to patients undergoing an MRI and will alert the public when this information has been added. Until then, the agency recommends that people wearing medicated skin patches, including nicotine patches, talk to a health care professional about their patch at the time they receive their MRI referral. The professional will advise the patient about when to remove the patch before the procedure and about replacing it after the procedure.

Patients should also tell their MRI facility that they are using a patch when they call to schedule their appointment and should repeat this information when filling out their health history questionnaire after arriving for their appointment.

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FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.



-- Online : www.fda.gov/MedWatch/report.htm

-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787

-- Fax: (800) FDA-0178

-- Phone: (800) FDA-1088

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FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs

The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).

"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."

Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis. Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.

Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.

In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading. Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.

"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."

Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.

Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.

Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.

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FDA Approves Updated Labeling for Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

"As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks."

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug's use.

One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Raptiva was approved in 2003. It is manufactured by Genentech, Inc. of San Francisco, Calif.

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FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

Background: The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.

The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

Over the last year, FDA has been working on several fronts to address the safe use of nonprescription OTC cough and cold medicines in children.

FDA has held two public meetings to hear from stakeholders and consumers on the issue, most recently, a public hearing that focused on labeling of these products on Oct. 2, 2008. In January of this year, FDA issued a nationwide Public Health Advisory recommending that these products not be used in children under the age of two because of the risk of serious and potentially life-threatening side effects.

Another part of the agency's work includes outreach to other public health agencies, consumer and patient groups companies that manufacture these products, and CHPA.

FDA will continue to work with the Centers for Disease Control and Prevention to monitor the ongoing use of these products and to develop educational materials for parents and consumers. The Agency will also continue to reach out to the scientific community to obtain more up-to-date information and scientific data about the effects of these products in children so that it can take the appropriate regulatory steps moving forward.

All these areas are vital to support the development and review of data regarding the safe and effective use of these products.

FDA is proceeding with its rulemaking process to update the existing OTC monograph for cough and cold products for children, and will consider input from the recent hearing of Oct. 2. The rulemaking process affords additional opportunity for the submission of data and public comment.

Until all these issues are resolved, FDA continues to recommend to parents and caregivers the following:

• Do not give children medications labeled only for adults.
• Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
• Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children.
• Check the "active ingredients" section of the DRUG FACTS label of the medicines that you choose. This will help you understand what symptoms the "active ingredients" in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
• Be very careful if you are giving more than one medicine to a child. If you are giving more than one medicine to a child make sure that they do not have the same type of "active ingredients." If you use two medicines that have the same or similar active ingredients, a child could get too much of an ingredient and that may hurt your child. For example, do not give a child more than one medicine that has a decongestant.
• Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of these products can lead to serious and potentially life threatening side effects such as rapid heartbeat, drowsiness, suppression of the respiratory system, seizures and other adverse events.
• Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use common household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines.
• Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child’s symptom(s) such as runny nose, congestion, fever and aches and do not shorten the length of time your child is sick.

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FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.

Today's announcement does not impact products from Ranbaxy's otherplants which are not affected by today's actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The FDA recommends that consumers continue taking their medications manufactured by Ranbaxyand not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.

Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA's drug compliance office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products

Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.

The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.

"With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research (CDER). "The FDA has notified other agencies and health care professionals to make them aware of today's actions so that they can take appropriate action and advise patients as needed." The Warning Letters issued today document the results of FDA investigations at these two sites.

One Warning Letter addressed problems at Ranbaxy's Dewas facility found during an inspection conducted by FDA in early 2008. During that inspection, FDA investigators documented significant cGMP deviations in the manufacture of sterile and non-sterile finished products and violations with respect to the manufacture and control of APIs. Specific areas of concern included the following aspects of the firm's quality control program:

• The facility's beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
• Inadequate batch production and control records;
• Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
• Inadequate aseptic (sterile) processing operations.

The second Warning Letter addressed the Paonta Sahib facility following an inspection at its Batamandi unit, also in early 2008.This inspection documented various cGMP deficiencies, including the following:

• The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;
• Inaccurate written records of the cleaning and use of major equipment;
• Incomplete batch production and control records; and,
• Inadequate procedures for the review and approval of production and control records for drug products.

Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for each of the facilities. In mid-April and May, Ranbaxy responded in writing to these findings in lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy's responses, and the firm's overall inspectional history, an evaluation that required substantial time due to the complex scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and the firm's responses. Ultimately, FDA concluded that the firm's responses were not adequate and that the Warning Letters were the appropriate regulatory response.

"Today's actions are clearly warranted by the serious violations established by FDA's investigations at these two sites," said Deborah M. Autor, director, CDER's Office of Compliance, FDA. "Until the company addresses these deficiencies, APIs and finished drug products from these plants will remain on the Import Alert, and we will not approve any Abbreviated New Drug Applications or New Drug Applications that list either of the two facilities as the manufacturer of APIs or finished drug products."

This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.

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FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes

The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

FDA recommends that consumers not eat raw red Roma, raw red plum, raw red round tomatoes, or products that contain these types of raw red tomatoes unless the tomatoes are from the sources listed below. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made. Consumers should continue to eat cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, or tomatoes grown at home.

On June 5, using traceback and other distribution pattern information, FDA published a list of states, territories, and countries where tomatoes are grown and harvested which have not been associated with this outbreak. This updated list includes: Arkansas, California, Georgia, North Carolina, South Carolina, Tennessee, Texas, Belgium, Canada, Dominican Republic, Guatemala, Israel, Netherlands, and Puerto Rico. The list is available at www.fda.gov/oc/opacom/hottopics/tomatoes.html#retailers. This list will be updated as more information becomes available.

FDA’s recommendation does not apply to the following tomatoes from any source: cherry, grape, and tomatoes sold with the vine still attached.

FDA recommends that retailers, restaurateurs, and food service operators not offer for sale and service raw red Roma, raw red plum, and raw red round tomatoes unless they are from the sources listed above. Cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, may continue to be offered from any source.

Since mid April, there have been 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin. Salmonella Saintpaul is an uncommon type of Salmonella.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that will be ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source of the tomatoes associated with the outbreak.

FDA is taking these actions while the agency continues to investigate this outbreak with state and federal partners. Such actions are a key component of FDA’s Food Protection Plan, a scientific and risk-based approach to strengthen and protect the nation’s food supply.

FDA will continue to issue updates as more specific information becomes available.