In a strange move, the FDA recently removed several restrictions for the prescribing of a popular and dangerous diabetes drug known as Avandia. After a 2007 study linked the drug to increased risk of heart attacks, Avandia was largely discredited and sales curtailed significantly in the U.S., much to the dismay of its manufacturer, GlaxoSmithKline. Dangerous drug attorneys at Pintas & Mullins Law Firm are wondering what caused the FDA to do a 360 on the drug.
Although the study was released in 2007, warnings were added to Avandia’s labels in 2002 regarding its cardiovascular risks. Labels for both Avandia and Actos, a related diabetes drug, were re-classified as black box warnings in 2007 (the most serious designation for prescription drugs, signifying the potential for serious injury or death). The black box labels warned of the risk of congestive heart failure. In addition to Actos and Avandia, a third diabetes drug in this class, Rezulin, was banned in 2000 due to high reports of liver toxicity.
Then, in 2010, the FDA severely restricted the use and prescription of Avandia, citing the 43% increased risk of heart attacks in diabetic patients prescribed to the drug. Glaxo was also forced to pay about $3 billion in fines because of its fraudulent marketing practices and failure to report safety information about Avandia to the federal government. Now, three years later, the agency is lifting its restrictions, citing new, contradictory data.
How this Will Affect Real Patients
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According to a doctor interviewed by the New York Times, the FDA’s new leniency will not persuade many doctors to start prescribing Avandia again to their patients. In fact, the clinic director of the Mount Sinai Hospital stated that neither patients nor doctors will be willing to overlook three years of safety concerns. In fact, the director went so far as to say the FDA’s decision was largely irrelevant, at least in clinical practice.
Another expert, a cardiologist at the Cleveland Clinic, also told the Times that the FDA development was merely an attempted cover-up, to mask embarrassment of the public scrutiny it came under for approving Avandia in the first place.
Glaxo stated that it did not intend to push advertising for Avandia in response to the lifted restrictions, which is likely due to the fact that its patent expired in 2011, making cheaper generics readily available. Prior to 2010, when the initial restrictions were put in place, Avandia was prescribed to over 120,000 diabetic patients in the U.S. As of June 2013, that number has dwindled to 3,000.
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For the past three years, the FDA has required physicians to register all patients they prescribe Avandia into a Risk Evaluation and Mitigation Strategy program. This program allows the FDA to track patients taking certain drugs to ensure the benefits outweigh the risks. Now that the risks seem to be diminishing, the FDA will no longer require patients to be registered to this program. Glaxo will also no longer be required to conduct a study specifically comparing Avandia to its rival Actos, which has recently been subject of mass litigation because of its association with bladder cancer.
Our team of Avandia attorneys has been working on these and Actos cases for several years now, and is actively investigating cases of heart attacks caused by Avandia and bladder cancer caused by Actos. If you or a loved one experienced a serious complication from any prescription drug or have any questions related to dangerous drugs or medical devices, contact our firm for a free legal evaluation.