FDA Issues “Black Box” Warning for GlaxoSmithKline Diabetes Mellitus Type II Drug Avandia

      On August 14, 2007 The FDA mandated a “Black Box” warning for the GlaxoSmithKline (GSK) diabetes mellitus type II drug, Avandia. Black Box warnings are the strongest and most serious form of warning from the FDA. The upgraded warning emphasizes the drug Avandia may cause or worsen heart failure in certain patients:

WARNING: CONGESTIVE HEART FAILURE (Avandia labeling with boxed warning approved 8/14/2007)

• Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (see WARNINGS). After initiation of AVANDIA, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDIA must be considered.
• AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated. (See CONTRAINDICATIONS and WARNINGS.)

FDSA post marketing surveillance addresses concerns of significant weight gain and edema-warning signs of heart failure sometimes leading to death associated with use of the drug Avandia.

Other serious diseases including congestive heart failure, stroke, edema, macular edema, macular degeneration, Primary Pulmonary Hypertension (PPH), and bone fractures have all been reported with Avandia usage.

Hersh & Hersh has developed an expertise in Avandia cases and is currently undertaking Avandia litigation. If you or a loved one has been injured due to taking Avandia, please contact us online or email us at general@hershlaw.com for more information.

As with all prescription medications, please consult your physician for your own treatment options. Do not discontinue this drug without medical supervision.

Related News

FDA Issues Safety Alerts on Avandia

On August 14, 2007, the U.S. Food and Drug Administration issued a BLACK BOX warning for AVANDIA labels.

On May 21, 2007 the U.S. Food and Drug Administration issued an alert warning of a potential and significant risk of heart attack and heart related deaths from use of Avandia.

Avandia is one of a class of drugs used to treat diabetes mellitus type II. Avandia acts by lowering plasma levels of insulin while increasing insulin sensitivity. Over 6 million Americans have used the drug to treat adult-onset, or type 2, diabetes.

In May 2007 the New England Journal of Medicine published a pooled analysis of over 40 clinical trials studying cardiac events and the use of Avandia. The rate of heart attack and risk of death from cardiovascular events was significantly increased in Avandia users. The study suggested that diabetic Avandia patients have a 43% higher rate of heart attack and 64% increase in the death from all cardiac events over diabetics not using Avandia. However, the study noted there were limitations to the study and recommended additional studies. In actuality, the cardiovascular risks from Avandia may be much higher than this study suggested. Other adverse effects potentially include congestive heart failure, stroke, macular edema, macular degeneration, edema, PPH and increased chest pain.

If you believe you or a loved one has suffered serious side effects associated with Avandia please keep in mind that there may be time limits on when you can commence suit. As with all medications, patients should consult a physician prior to changing or stopping any medication.