FDA Review Spotlights Heart Risk of Diabetes Pill

A study by GlaxoSmithKline has been attacked by federal health scientists. The study had been used by the company to defend the diabetes drug, Avandia. The drug, at one time a huge seller, has been linked to heart attacks.

The Food and Drug Administration is to meet to decide if the drug should remain on the market. At the meeting the FDA will look at recommendations from a group of outside doctors, which could include banning the drug, limiting prescriptions for the drug, or adding more warning labels.

Glaxo has referred to a study that it said proved the safety of Avandia. The FDA disagrees claiming the study was seriously flawed. The study was biased since the chief clinical trial was set up to offer reassurance on the safety of the drug.

Diabetics are unable to break down carbohydrates because of the body’s inability to produce insulin. This leaves them at a higher risk for heart attacks, blindness, or kidney problems. Avandia increases the body’s sensitivity to insulin.

According to IMS Heath’s statistics, Avandia had been Glaxo’s third best selling drug. Its United States revenue was $2.2 billion in 2006. In 2007 studies start linking Avandia to heart attacks and sales fell by 75%. Last year’s sales were only $520 million.

In 2007 the FDA added warning labels to the drug, but a panel of experts voted to keep it on the market.

Critics of Avandia said there were not enough large studies done before the drug was approved for the sale. The FDA is under political pressure to pull the drug. Republican Senator Charles Grassley on the Senate Finance Committee has called for the banning of the drug.