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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Fluoride Could be Contributing to Early Puberty, Studies Show

/PRNewswire/ -- The medical and public health community is shocked by the news that young American girls are reaching puberty at ages as young as 7 years (1). However, according to Paul Connett, PhD, Director of the Fluoride Action Network, "If fluoride's dangers had not been taken off the scientific radar screen by the US Public Health Service when it prematurely endorsed fluoridation in 1950, maybe key warning signals would not have been ignored for over 50 years."

In 1956, it was reported, after one of the first fluoridation trials (1945-55) had been completed in Newburgh/Kingston NY, that young girls were starting to menstruate on average five months earlier in fluoridated Newburgh compared to non-fluoridated Kingston (2). This result was ignored and there was no follow-up research.

In 1997, Dr. Jennifer Luke in the UK, as part of her PhD thesis (3), reported that fluoride accumulates in the human pineal gland. The pineal gland produces the important hormone melatonin which acts like a biological clock. One of the processes it is thought to control is the onset of puberty. Luke published this work in 2001 but the result has been ignored and no fluoridating country has attempted to repeat her findings, something which would be easy to do if there was the will to do so.

Luke also found that animals exposed to fluoride had lowered melatonin levels and showed signs of reaching puberty earlier. Again this result has been ignored and no fluoridating government has attempted to repeat Luke's work.

Connett says, "We are not saying that exposure to fluoride is a definite cause of early puberty in girls, but not pursuing this possibility is bad for science, bad for medicine and bad for public health."

Simply put: if you don't look, you don't find. The medical community is being kept in the dark on the possibility that fluoride, a highly toxic substance, which is deliberately added to the drinking water of 184 million Americans daily, is causing a variety of harms from the subtle to the serious.

Connett says, "Apparently, it has become more important for the American Dental Association and the Centers for Disease Control and Prevention and other agencies of the US Department of Health and Human Services to protect this outdated, unethical, ineffective and the dangerous practice than it is to protect the health of the American people. Key research is not being done. Doctors are not being warned."

This and other tragic aspects of the US's peculiar obsession with fluoridation are to be documented in an upcoming book co-authored by Connett. The book, titled "The Case Against Fluoride: How Hazardous Waste Ended Up in Our Drinking Water and the Bad Science and Powerful Politics That Keep it There," will be published by Chelsea Green in early October of this year.

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CSTE Leads Effort to Improve Blood Lead Reporting

/PRNewswire / -- Citing evidence that even a very low level of blood lead is a significant health risk at any age, the Council of State and Territorial Epidemiologists (CSTE) is recommending a change in the case definition of elevated blood lead levels in adults. In a vote at the CSTE annual conference in Buffalo, NY, State Epidemiologists approved a proposal to consider blood levels of 10 ug/dl or more in adults as "elevated" -- the same standard as currently exists for children.

Studies show that blood lead levels as low as 10 ug/dl contribute to an elevation in blood pressure and attendant health risks, including stroke. Low blood levels also are associated with an increase in mortality from heart disease, decreased kidney function and changes in cognition.

"Having this additional data will allow researchers, epidemiologists and the public to know more about the burden of lead poisoning across the age spectrum," CSTE President Mel Kohn, M.D., M.D.H. said. "While we often think of lead poisoning as a health concern in children and pregnant women, we need to address how lead poisoning is affecting adults, from exposure in the workplace and from hobbies such as target shooting."

The risk of lead poisoning is especially pronounced among workers in certain industries, including lead refining and smelting; construction work involving paint removal; manufacture of bronze and brass products such as plumbing fixtures; demolition and maintenance of outdoor metal structures such as bridges and water towers; and battery manufacturing and recycling.

Many occupational exposures are not identified because not all employers do the required occupational testing. Compounding the problem is the fact that only a fraction of known occupational cases are included in national health statistics, which currently only include counts of individuals with blood lead levels 25 ug/dl and greater.

Some states are already obtaining reports from laboratories of individuals with blood lead levels lower than 25 ug/dl and share this information with the Centers for Disease Control and Prevention/National Institute of Occupational Safety and Health Adult Blood Lead and Epidemiology (ABLES) Program. ABLES received reports of 12,935 adults with blood lead levels from 10-24 ug/dl who were tested in 2007 in 21 states, compared to reports of 5,419 adults with blood lead levels of 25 ug/dl and above in these same states. These reports are likely minimum estimates of the true magnitude of the problem.

"The current ABLES data for adults with blood lead levels of less than 25 ug/dl reflects only sporadic reporting," Dr. Kohn said. "The result is a significant underestimation of the health impact of elevated blood lead levels in the population of the United States that will be greatly alleviated by the new recommended reporting practices. With more complete reporting, we will have a clearer picture of the true scope of the problem to guide our efforts to prevent lead poisoning. This will reduce the toll of lead exposure on the health of Americans of all ages."

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