FDA Approves New Indication for Crestor

On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it.

The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.

Specifically, this includes men 50 years of age and older and women 60 years of age and older who have an elevated amount of a substance known as high sensitivity C-reactive protein in their blood and at least one additional traditional cardiovascular risk factor such as smoking, high blood pressure, a family history of premature heart disease, or low amounts of high-density lipoprotein or HDL cholesterol, the so-called “good cholesterol.”

This new indication does not support the use of Crestor in individuals who have an elevated high sensitivity C-reactive protein but no traditional cardiovascular risk factors.

Crestor is in a class of drugs called statins, which work by stopping an enzyme called HMG-CoA reductase from making cholesterol. High amounts of low-density lipoprotein or LDL cholesterol, the so-called “bad cholesterol,” is a known risk factor for heart attacks, strokes, and heart disease.

“This expanded indication for Crestor will provide health care providers with a new therapeutic option to help appropriately-identified people lower their risk for a cardiac event,” said Eric Colman M.D., deputy director, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

The new indication was based on results from a study called the JUPITER trial, which compared 8,901 patients who received Crestor for two years to the same number of patients who received a placebo. Patients who took Crestor experienced fewer cardiac events, including heart attacks and strokes, and underwent fewer procedures such as coronary angioplasty or coronary artery bypass surgery to treat or revascularize their arteries.

High sensitivity C-reactive protein is a nonspecific indicator of inflammation, which is associated with the buildup of cholesterol and other fatty material in the coronary arteries.

Crestor is already approved for use in combination with diet and exercise to lower LDL cholesterol and a related substance known as triglycerides in patients with a high amount of these substances in their blood. The medication is also approved to slow the progression of atherosclerosis – a thickening of the artery wall due to the buildup of cholesterol and other fatty materials.

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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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Asthma Sufferers Breathe Easier as Walmart Announces $9 Environmentally Sustainable Inhaler

/PRNewswire-FirstCall/ -- As part of its continued commitment to provide accessible, affordable medications to those who need it most, Walmart today announced it will carry an environmentally friendly albuterol rescue inhaler starting at $9, the lowest-priced inhaler on the market. The ReliOn(R) Ventolin HFA inhalers, sold exclusively at Walmart*, will ease the transition as asthma sufferers are forced to replace their CFC-powered inhalers with new HFA inhalers in the new year to comply with an FDA mandate.

"While some HFA inhalers may sell for as much as $60 for certain brands, our $9 ReliOn Ventolin HFA inhaler will ease the financial burden for sufferers of asthma who should not go without these life-saving medications," said Sandy Kinsey, Walmart's divisional merchandise manager for pharmacy. "As an advocate for our customers, we're committed to ensuring they have access to affordable medicine they cannot live without."

According to the 2007 National Institutes of Health (NIH) asthma treatment guidelines, overuse of albuterol is a sign of uncontrolled asthma. With 60 metered inhalations, the ReliOn Ventolin HFA inhaler helps both patients and health care professionals monitor and track usage via the dose counter to identify overuse of albuterol. Additionally, it helps patients track how many puffs remain in their inhaler so they do not run out of their rescue medication when they need it most.

Walmart offers other affordable medications* for those suffering from the disease, including:

Albuterol 2mg tab $4 for 90 tablets $10 for 270 tablets
Albuterol 4mg tab $4 for 60 tablets $10 for 180 tablets
Albuterol 2mg/5ml syrup $4 for 120ml $10 for 360ml


For further information about Walmart's affordable prescription program, customers can visit http://www.walmart.com/pharmacy or discuss the program with their local Walmart, Neighborhood Market or Sam's Club pharmacist.

* Products and pharmacies are not available in North Dakota

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Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful

A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.

The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.

"The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals."

CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications (situations when the medicine should not be used), symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional.

"We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution," said Woodcock.

In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings. In addition, the FDA has created a Web site to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.

The FDA regulates prescription drug labeling written for health care professionals and Medication Guides and Patient Package Inserts written for consumers, but the agency does not review or approve CMI leaflets. The agency's role, as set forth by Congress, has been to encourage the private sector to provide this information, supply the companies with the necessary guidance and evaluate the private sector's progress.

The FDA-sponsored study was conducted by the National Association of Boards of Pharmacy through a subcontract with researchers at the University of Florida, College of Pharmacy. Shoppers trained to simulate patients visited pharmacies randomly selected throughout the United States. The shoppers gave the pharmacists prescriptions for two commonly prescribed drugs, metformin and lisinopril, and collected the CMI provided with the prescriptions. Expert and consumer panels evaluated the quantity and quality of this information.

There were some improvements shown by the new study when compared to a similar evaluation of CMI in 2001, Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001. That study revealed that 89 percent of patients received written information when their new prescriptions were filled, but only about 50 percent of the CMI met minimal criteria for usefulness.

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Problems with Boniva, Actonel & Fosamax

Many are taking Fosamax, Boniva and other similar drugs designed to stave off osteoporosis. Here's two articles we encourage you to read:

Fosamax, Boniva & Actonel Linked To Jaw Bone Disorders

http://injury-law.freeadvice.com/drug-toxic_chemicals/fosamax-linked-to-jaw-bone-disorders.htm

Merck Braces for Flood of Fosamax Lawsuits
Osteoporosis Medication Can Destroy Patients' Jawbones

http://www.consumeraffairs.com/news04/2007/02/fosamax.html