02/24/2010 — Avandia (rosiglitazone mleate), marketed by drug giant GlaxoSmithKline, is the brand name for an oral anti-diabetic agent that was approved by the Food and Drug Administration (FDA) in 1999. Over six million diabetics worldwide have taken Avandia to help control their blood sugar levels.
While Avandia may be helpful in treating diabetes, it has been found in independent clinical studies to dramatically increase the risk of heart attack or heart failure. Some studies found the risk of heart attack while taking Avandia increased by 43 percent and the risk of dying from cardiovascular causes while taking the drug increased by 64 percent. Avandia’s harmful side effects first came to light following a 2007 study by the Cleveland Clinic, and since then 42 different clinical trials involving nearly 28,000 people have been conducted.
Researchers have concluded that Avandia may be capable of provoking heart attacks or death from cardiovascular illness even after relatively short-term exposure in patients who are already susceptible to these conditions.
Recently, an FDA advisory committee was assembled to assess whether or not Avandia should continue to be sold. Now, two officials from the FDA are recommending that Avandia be pulled from the market because of its potential to harm the heart, The New York Times reported. Clinical analyses suggests that if every diabetic taking Avandia switched to a different medication, about 500 heart attacks would be averted each month.
In the third quarter of 2009, Avandia was linked to 304 deaths, The Times reported.
Lawsuits launched throughout the United States and Canada accuse GlaxoSmithKline of knowing about the severe side effects of Avandia and failing to disclose them to the FDA and the public. Since it was approved in 1999, thousands of Avandia users have suffered serious and potentially fatal injuries.
Patients taking Avandia should be on the lookout for signs and symptoms of heart failure, including excessive, rapid weight gain, dyspnea (shortness of breath) and/or edema (buildup of excessive fluid in body tissue), persistent coughing or wheezing, fatigue, lack of appetite or nausea, confusion or impaired thinking, and increased heart rate.
Other conditions caused by Avandia include liver toxicity, severe allergic reaction, bone fractures, macular edema (vision loss), and stroke.
The FDA, meanwhile, has urged diabetics taking Avandia to talk to their doctors about whether they should remain on the treatment. Sales of the drug topped $3 billion in 2006, but have since slumped as negative results of the studies became public. There is no generic equivalent for Avandia.