FDA Lifts Some Restrictions on Prescribing Avandia to Reflect New Cardiovascular Research
Results from a new study have led the Food and Drug Administration to lift restrictions for doctors on prescribing the controversial drug Avandia.
The clinical trial, Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD), showed no elevated risk of heart attack or wrongful death for patients who were treated with Avandia, compared to more typical diabetes drugs. The first clinical trial to report a potential increase in heart attack risk was in 2007, and this new study did not back up those findings.
The original clinical study, conducted by Dr. Steven Nissen, head of cardiology at the Cleveland Clinic, reported a meta-analysis of in which data from 42 studies collectively showed a 43% increase in risk of heart attack directly related to taking Avandia.
Due to the initial 2007 findings, Avandia, which was one of GlaxoSmithKline’s blockbuster drugs, was completely pulled from the market in Europe, and the US required the drug to have a black box warning, which is the strongest prescriber warning the FDA can require.
“GSK welcomes the decision of the FDA and appreciates the agency’s robust review of the science with regard to Avandia,” Glaxo said in an emailed statement. “GSK maintains its view that Avandia is a safe and effective treatment for Type 2 diabetes when used appropriately.”
However, Avandia lost patent protection in 2011, so GSK is not likely to try to market the drug again, despite lifted restrictions. The restriction does, however, pave the way for more generic versions of the drug.
“Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions,” Woodcock said.
Glaxo said that it would work with the FDA and change Avandia’s labeling to reflect the new information. The FDA also said that, due to the new safety findings, it would not require GSK to conduct a study comparing Avandia to Actos, another much-maligned Type 2 diabetes drug produced by Takeda Pharmaceuticals.
The news about the change comes after GSK settled whistleblower allegations about fraudulent marketing practices with Wellbutrin and Paxil, and failing to report potential safety problems with Avandia. The settlement came to $3 billion, an historic amount for a drug company to settle with the US government and admit guilt.
The Strom Law Firm Can Help with Avandia Personal Injury Lawsuits
Did you or a loved one suffer any of the following injuries?
- Undergoing treatment for Congestive Heart Failure
- Heart Attack
- Congestive Heart Failure resulting in death
Avandia side effects can be mild or, in some cases, can even cause death. The way your body reacts to Avandia depends on a variety of factors – your overall health and medical history for instance.
The pharmaceutical liability lawyers at The Strom Law Firm, LLC are at the forefront of the fight to protect the public and will stand up for your rights against the big drug and insurance companies that produce dangerous drugs and products like Avandia. We will fight to ensure that you and your loved ones receive the justice you deserve. Contact our defective drug and wrongful death attorneys at the Strom Law Firm, LLC today for a free consultation to discuss the facts of your case as well as your legal rights. Contact us today. 803.252.4800.