Avandia Information and Warning

A recent study raises concern about Avandia, GlaxoSmithKline’s (GSK) best-selling and widely prescribed oral diabetes drug. Avandia, generic resiglitazone maleate, is a PPAR agonist, a kind of drug that functions by activating and suppressing genes. Several other kinds of PPAR agonists have been denied approval by the FDA (Food and Drug Administration) because of serious side effects.

The new study is a meta-analysis of 42 predominantly short-term studies that appeared as a headline article in the May 21, 2007 online Journal of New England Medicine (JNEM). The article got extra attention because one of the authors, Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic, raised concerns several years before that Mereck’s painkiller Vioxx caused heart problems. Vioxx was later removed from the market and was the target of several lawsuits. Now Dr. Nissen is giving an Avandia warning that the drug is potentially deadly to type 2 diabetes patients.

Dr. Nissen and his fellow author, Kathy Wolski, M.P.H., did a meta-analysis of the results of 42 studies reported on the GlaxoSmithKline and FDA websites. Their analysis showed that Avandia significantly raised the risk of heart attack or other heart problems by 43%. Dr. Nissen admits that there are weaknesses in his study because he relied on public information and didn’t have access to the source data for patients in the various studies. As a result, he was unable to do some analysis. Nevertheless, Dr. Nissen thinks his results are cause for alarm.

Heart disease is the leading cause of death for people with diabetes, with 65% of deaths caused by cardiovascular problems. In that population a drug that increases the risk of heart attacks and other cardiovascular problems could have devastating effects. For that reason Dr. Nissen is advocating more studies of Avandia’s side effects and stricter FDA requirements for approving such drugs. See Avandia Side Effects and Risks for more information about criticism of FDA monitoring of Avandia safety.

GlaxoSmithKline is denying that Avandia creates a significantly increased risk of heart attack or other cardiovascular problems. Glaxo claims that its long-term trials do not show a significant increase in risk.

On the other hand, Bruce M. Psaty of the University of Washington’s cardiovascular health research unit and Curt D. Furberg of the Wake Forest University division of public health wrote an editorial that accompanied the May 21, 2007 NEJM article, in which they questioned the wisdom of prescribing Avandia until the questions about its side effects have been resolved.

Another 2007 study revealed a less serious, but still significant Avandia side effect. The study found that women taking Avandia, and some other drugs manufactured by GSK, have an increased risk of bone fractures, particularly in the upper arm, hand, and foot. While this is not life threatening, the heath consequences on millions of women who take Avandia could be significant. Men don’t appear to suffer this side effect.

Check out the following articles for more information about Avandia, filing an Avandia lawsuit and finding an Avandia attorney.