Avandia Poses Serious Heart Risks

Type 2 diabetes drug, <"http://www.yourlawyer.com/topics/overview/avandia">Avandia, has long been connected to significant risks of heart attack, strokes, and heart failure. As a matter-of-fact, this September 2010, the U.S. Food & Drug Administration (FDA) placed severe restrictions on Avandia, citing these dangerous health risks. Avandia has also been restricted in Canada, and its sales have been suspended in Europe.

This means that US patients can only be prescribed Avandia after they and their physicians confirm that they have exhausted all other prescription avenues and that the patient confirms he/she has been told about the cardiac side effects connected to Avandia.

Known generically as rosiglitazone, Avandia is marketed stand-alone, as Avandia; in combination with metformin, as Avandamet, or with glimepiride, as Avandaryl. Since November 2007, Avandia’s label has included a black box warning, the agency’s strongest, which discussed Avandia’s link with myocardial ischemia. That warning was included after the respected Cleveland Clinic published a meta-analysis of 42 clinical trials that revealed that patients taking Avandia experienced a 43-percent increased risk of suffering a heart attack.

In the summer of 2010, the FDA convened an outside advisory panel to consider Avandia once again. The panel voted 20-12 to recommend that Avandia be allowed to stay on the market; however, 10 members voted its sales be restricted and warnings on its label regarding heart risks be strengthened.

Evidence presented to that panel included a study conducted by Dr. David Graham of the FDA’s Center for Drug Evaluation and Research, in which it was found that of 227,500 patients in the US Medicare system who took Avandia likely underwent some 48,000 heart attacks, strokes, and other problems between 1999 and 2009. The study found that patients who took Avandia were 27 percent likelier to suffer a stroke, 25 percent likelier to develop heart failure, and 14 percent likelier die, versus patients taking the diabetes medication, Actos.

In September, acting on the panel’s recommendation, the FDA imposed the current restriction on Avandia. The FDA also ordered Glaxo to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, another study considered by the advisory panel in which the cardiovascular safety of Avandia was compared to standard diabetes drugs. RECORD was released in 2009, and did not find increased heart risks as other Avandia studies have, and was touted by Glaxo as evidence of the drug’s safety. RECORD was widely criticized for a range of reasons and the agency posted an Avandia briefing document on its website stating that RECORD was “inadequately designed and conducted to provide any reassurance about the CV (cardiovascular safety) of rosiglitazone …” RECORD results “confirm and extend the recognized concerns regarding heart failure” and possibly suggest an increased risk for heart attacks. The FDA review revealed at least a dozen cases in which patients taking Avandia suffered serious heart problems not included in the trial’s adverse events lists.

The FDA also halted a Glaxo-funded clinical trial known as TIDE, rescinding all regulatory deadlines for completion of the trial, which was designed to compare Avandia to Actos and to standard diabetes drugs.

Help filing claims and other legal assistance for the victims of Avandia, Avandamet, or Avandaryl is is available at <"http://www.yourlawyer.com/topics/overview/avandia">www.YourLawyer.com.

This entry was posted in Avandia, Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.