FDA Issues Stronger Avandia Warning

Avandia, an oral medication used for treatment of Type 2 diabetes has been under harsh scrutiny since the publication of a study in the New England Journal of Medicine, which claims that Avandia has been linked to a significantly increased risk of heart attack among patients taking it for diabetes. The findings of this study then prompted the federal Food and Drug Administration to issue a safety alert Avandia warning for doctors and patients. The FDA stopped short of actually instituting any recall of the drug, contingent on further examination of medical research on the drug. The stronger Avandia warning is now required to be included with any Avandia medication prescribed to patients. The Avandia warning is what is called a black-box warning, the FDA's strongest form of warning about a drug's potential side-effects. In addition, the FDA also stated in their safety alert Avandia warning that any patient taking Avandia for treatment of Type 2 diabetes should consult with their doctor about other possible treatment options.

Previous Attempts to Issue an Avandia Warning May Have Been Rebuked

Following the release of the New England Journal of Medicine's study and the subsequent stronger Avandia warning issued by the FDA, many began to wonder how this potentially serious side-effect could have escaped the FDA's notice. Shockingly, the New York Times reported in an June 6, 2007 article that previous attempts to put a black-box Avandia warning on the medication may have been suppressed. A supervisor in the drug safety office at the FDA, Dr. Rosemary Johann-Liang, stated that in March 2006 she approved a stronger Avandia warning, based on information that Avandia could lead to swelling of the heart, and ultimately heart failure. However, according to Dr. Johann-Liang, officials at the FDA who worked closely with Avandia's manufacturer GlaxoSmithKlein complained about the stronger Avandia warning, and as a result she was ordered to retract her approval for the black-box Avandia warning. In addition, she was also removed from her supervisory position and could therefore not issue any other Avandia warning.

What Should You Do in Response to the Avandia Warning?

Any patient who has been taking Avandia to treat Type 2 diabetes should heed the FDA's Avandia warning and immediately consult with their physician to determine what, if any, other treatment course should be followed. Once the proper treatment has been determined, patients may want to consider consulting an experienced Avandia attorney to evaluate their specific case and how it may relate to any possible Avandia litigation. As a result of the Avandia warning, as of June 12th one class-action Avandia lawsuit has already been filed against GlaxoSmithKlein. Other lawsuits may follow, and many Avandia patients may be eligible for compensation. Patients seeking more information about the Avandia warning and possible Avandia litigation can contact a qualified Avandia attorney by simply filling out the Avandia Warning Case Evaluation Form below, and an Avandia lawyer will contact them regarding their case.

Avandia Warning Case Evaluation Form