Avandia Drug Gets Black Box Warning Because of Increased Risk for Heart Attack

11/18/2007- The GlaxoSmithKline diabetes drug Avandia will have a new black box warning added to their product. The Black Box warning is the most severe warning a drug can have, and this is the second warning for Avandia. This second warning may be a little watered-down because it states that the results are not conclusive.

The FDA is warning doctors and patients that Avandia may cause heart attacks. The federal watchdog agency says doctors should monitor “people with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack.” According to Lawyers and Settlements, this will give the company a “seven-year reprieve from further scrutiny.”

The New England Journal of Medicine reported last spring that the drug increases the heart attack risk by 43 percent. Although questions about the drug have been raised since 2000, Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, believes the FDA has moved fast enough.

"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," Janet reported. "(The) FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."

Other manufactures of similar drugs in the same class were not let off so easy, according to the Lawyers and Settlements report. The other labels will not say that the results were not conclusive.

Problems for Avandia help the competing drug Actos. Doctors may opt for prescribing Actos since Avandia is the only diabetes drug linked to heart attacks or heart failure. Diabetes patients are more prone to cardiovascular problems.