California Injury Attorney Blog

This week, the Food and Drug Administration (FDA) gathers its panel of outside medical experts to determine the fate of Avandia, a diabetes drug. The California Injury Attorney Blog has posted previously on the Avandia controversy and more information is available here.

The Wall Street Journal has an interesting angle on Avandia's moment of truth. They write that a big part of Avandia's fate can be viewed "[a]gainst a backdrop of legal maneuvering and internal struggles" within the FDA.

The question of Avandia's safety and the studies that have shown it to increase heart-attack, and other cardiac events, would seem to be the main event this week. But the WSJ says this is a "battle that could redefine" FDA's response to drug safety after approval and sale to the public.

The criticism of Avandia continues into this new phase of review. The diabetes drug was one of GlaxoSmithKline's big sellers until serious medical issues with its use began to arise. Another drug called Actos, which is made by Takeda Pharmaceutical Co., is also part of the review going on at FDA this week although the issues with Actos do not appear to be the same as with Avandia.

The larger issues center around how FDA handles Avandia in light of the safety issues it has presented. It has yet to be withdrawn from the market, despite evidence that it is harmful to some users. One study linked it a 43% increase in risk of heart attack. The recent study, called RECORD, funded by Glaxo and has been viewed critically and apparently came up with a different outlook on the heart attack risk.

At least one FDA doctor has said that the recent study was not well designed and has led to inaccurate results. As the Boston Globe reports, the issues regarding the safety of Avandia linger as the advisory panel convenes to consider what to do about this drug. Some in the FDA are calling the recent clinical trials, flawed.

We will keep you posted on the FDA's review.