Former FDA Regulator May Testify that GlaxoSmithKline Withheld Avandia Information
According to a recent article in Businessweek, a former FDA regulator may testify that GlaxoSmithKline, makers of the diabetes drug Avandia, withheld information indicating that Avandia increased the risks of heart trouble.
In a recent deposition, former FDA drug-safety unit manager Dr. Rosemary Johann-Liang testified that the FDA's 2001 study of Avandia found that the drug increased the risk of heart attack more than did rival medications. Glaxo also received an email from separate researchers stating that Avandia “strengthens the signals” of heart ailments, which it failed to turn over to the FDA.
Dr. Johann-Liang left the FDA in 2007 after recommending that Glaxo add additional warnings and information to Avandia's label about the risks Avandia posed to heart health. She stated that the FDA also provided Glaxo with internal information about how to improve the Avandia warnings.
An upcoming FDA advisory panel meeting in Washington will consider the risks Avandia poses of increasing heart attacks, strokes, and cardiovascular disease and whether these risks outweigh Avandia's beneficial ability to help control blood sugar. The panel may consider Dr. Johann-Liang's testimony when making its decision. The drug's manufacturer, GlaxoSmithKline, continues to maintain that no studies have proven that Avandia is dangerous.
Pharmaceutical companies have an obligation to provide consumers with the information they need to make their personal medical decisions. When information about a medication's potential harmful effects is withheld, the resulting side effects, injuries, and even deaths can affect a patient and his or her family for years to come.
If you or a loved one has been injured by a harmful or recalled drug, the experienced Avandia side effects attorneys at Anapol Schwartz stand ready to assist you. Our legal team will review the details of your case and help you hold negligent parties accountable as we fight to obtain the compensation you deserve. Please don't hesitate to call Anapol Schwartz today at 866-735-2792 for a free and confidential consultation.
