Since 1999, GlaxoSmithKline has been selling the drug Avandia for Type 2 diabetes. The medication Avandia has a single ingredient – rosiglitazone — which has been linked to literally hundreds of heart attacks and heart failures. Other medications Avandamet and Avandaryl contain this ingredient. These medications still await their shelf life fate.
The risk of heart problems with this medication are well established and are the subject an FDA black boxed warning and FDA safety alerts issued in 2007 and 2010. In addition, in December 2008 the FDA issued Guidance for Industry recommending that manufacturers study heart safety in formulating diabetes treatments.
The 2007 black box warning clearly indicates that patients with symptomatic heart failure should not take the medication. It also states that the medication causes or exacerbates congestive heart failure in some patients. Finally, it notes that the data on the risk of myocardial ischemia are not conclusive and are under review.
The data still under review by the FDA includes a clinical study called “Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes” or RECORD, which was designed to evaluate the cardiovascular safety of rosiglitazone.
The FDA’s completed review of this study is expected in July 2010. Once the FDA completes its review of the data from the RECORD study, the agency will present the cardiovascular safety data on rosiglitazone at a joint meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At this time, the Advisory Committee will provide updates on “the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.”
In the earlier warnings, the FDA noted the following recommendations to patients taking Avandia and medications with rosiglitazone, including: don’t stop taking the medication without healthcare professional advice; talk with your healthcare professional about concerns regarding this medication; read the risks included in the medication guide, and report side effects to the FDA’s MedWatch.
Earlier this year, The New York Times published an extensive piece on Avandia and rosiglitazone. The article noted the opinions of several scientists who have urged the removal of Avandia from the market and as well as the ongoing “fierce debate” at FDA over whether to allow it to continue to be sold.
If you or a loved one has taken Avandia or a medication containing rosiglitazone and have had suffered heart attack or other cardiovascular problems, contact Hersh & Hersh for a free consultation on your legal rights.
Related Web Resources
Visit the Food and Drug Administration’s site for more information on how drugs are approved for use.