FDA Panel Says Glaxo Diabetes Drug Avandia Should Stay on Market

An FDA advistory board has recommended that Avandia, a diabetes drug recenlty found to increase the risk of heart attacks in some patients, should stay on the market. The FDA usually follows such recommendations.

Earlier today, one FDA scientists, David Graham, recommended that the drug be pulled from the market. Graham, however, was apprently the odd man out. The rest of the panel voted that the drug should stay on the market (the vote was 22-1).

According to a Dow Jones story, some suggested the drugs label should carry a stronger "black box" warning indicating that the drug should not be taken along with insulin.

During the meeting, GlaxoSmithKline officials strongly defended Avandia and said there isn’t a difference in heart-attack rates when comparing Avandia to other diabetes drugs, such as metformin and sulfonylurea.

"None of these drugs are perfect," said Ronald Krall, Glaxo’s senior vice president and chief medical officer. "Avandia is an important option." Drugs like Avandia and Actos are typically added when older drugs metformin and sulfonylurea fail to properly control blood sugar.

Graham has a history of questioning the FDA’s drug approvals, and warned of problems with Vioxx long before the drug was pulled from the market in 2004.

On a related note, Steven Nissen, the lead author of the New England Journal of Medicine study that found the increased risk of heart attack was profiled in the New York Times on July 21.