Glaxo’s diabetes pill Avandia under FDA scrutiny again

By Dr. Ananya Mandal, MDJul 11 2010

GlaxoSmithKline (GSK) is under Food and Drug Administration (FDA) scrutiny again. This is for its diabetes pill Avandia which is under review for the second time in three years. The drug’s safety will be examined by the FDA in Washington by a high-level advisory committee. The meeting is supposed to last a couple of days and an expert panel will look into the available evidence which links Avandia to an increased risk of heart problems. They will decide whether the drug can remain in the market along with warnings or removed from sale altogether.

Avandia has been in a controversy for three years when in 2007 an FDA advisory committee convened to consider its safety. Dr Steve Nissen one of the critics of the drug had then said that the pill could be associated with a higher risk of heart attack and the panel had voted 22-1 to keep it on the market. But the fears affected sales with a total of £771m last year compared to £1.4bn in 2006. Hundreds of thousands of people still take the drug today.

This year fears rose again after publication of a report by a committee of US senators that spoke of the heart risk. GSK has refuted the risk claims by saying that the findings in the report are selected from damning evidence only. Dr Nissen then published his own study that added to evidence against Avandia. Then there was yet another report from an FDA reviewer, Dr David Graham, which found Avandia was more dangerous to the heart than its rival, Actos. GSK in retaliation has also published a comprehensive review of the drug last Friday and submitted it to the FDA claiming that the drug was safe. Dr Murray Stewart, GSK vice president for clinical development said, “Since 2007, we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show that this medicine does not increase the overall risk of heart attack, stroke or death.”

Now the expert panel will look into all the evidence that is gathered before coming to a final decision and the media now wonders what it is that has delayed a final decision for three years. As the controversy continues, so does the extensive litigation against the drug. Trial lawyer Ed Blizzard of Houston talking about the 11,000 lawsuits and pressure from safety advocates, politicians and some at the FDA to pull Avandia said, “Glaxo is at a crossroads here… Strategically, they need to get as many [cases] as possible out of the way soon, in case the FDA asks them to withdraw the drug.”