The FDA's Avandia Decision

August 13, 2010, 5:45PM. By Heidi Turner

Washington, DCNow that the US Food and Drug Administration's (FDA) advisory panel has met and made their recommendations, the FDA must now decide what to do about Avandia. Recent studies have suggested a risk of serious Avandia side effects, including an increased risk of heart attack. Although the advisory panel voted to keep Avandia on the market, with stricter warnings, the FDA can decide to withdraw the diabetes medication, if it feels the Avandia risks outweigh the drug's benefits.

The FDA has already faced this decision once. At the time, the FDA's advisory panel recommended that Avandia stay on the market. The decision was made after a 2007 study, published in the New England Journal of Medicine suggested that Avandia was linked to a 43 percent higher risk of heart attacks when compared with other medications or placebos.

According to an article in TIME (08/12/10), GlaxoSmithKline may have already known about the increased risk of heart attack. TIME reports, based on sealed court proceedings, that GSK officials met with FDA officials to convince them that evidence against Avandia was inconclusive. They reportedly managed this by focusing on data about general heart problems as opposed to heart attacks.

Specifically, GlaxoSmithKline officials reportedly told the FDA that recent Avandia studies, "yielded information that is inconsistent with an increased risk of myocardial ischemic events," (as quoted by TIME)

But, TIME notes, GlaxoSmithKline may already have known about the increased risk of heart attacks associated with Avandia. Two days prior to meeting with the FDA, GlaxoSmithKline's Global Safety Board reportedly noted that the Avandia studies seemed to strengthen the risk found in previous studies. And just over one week earlier, Moncef Slaoui, GlaxoSmithKline's head of research and development, sent an e-mail to the company's chief medical officer noting that Avandia patients showed between a 30 percent and 43 percent increased risk of ischemic event.

In January 2010, the Senate Finance Committee issued a report accusing GlaxoSmithKline of failing to promptly inform the FDA about the risks of Avandia. The FDA then undertook another review of Avandia and during that review, evidence was uncovered suggesting that a study of Avandia's safety—called RECORD—minimized the risks associated with Avandia, including omitting one death from the final numbers.

GlaxoSmithKline maintains that Avandia is safe and that the company has been forthcoming with information.

The FDA must now decide what to do about Avandia. Although the advisory panel has made its recommendations, those recommendations are not binding. The FDA can still choose to withdraw Avandia from the market if it believes the risks of Avandia outweigh the benefits.

In the meantime, the FDA has ordered GlaxoSmithKline to stop enrolling patients in its comparison study, which compared the safety of Avandia with the safety of Actos. Patients who are already enrolled in the trial are allowed to remain in it.