Product News and Recalls

FDA panel votes to reduce Avandia restrictions

A U.S. Food and Drug Administration panel has recommended allowing the diabetes drug Avandia to remain on the market with relaxed restrictions on its use, according to NBC News.

The story says Avandia was once the world’s top-selling diabetes drug. But in 2007, an analysis of other studies suggested that it raised the risk of heart attack by 43 percent. European regulators removed it from the market in 2010 and the FDA severely restricted its use in the United States.

In the intervening years, some other types of diabetes drugs that became increasingly popular ended up generating health concerns of their own.

For example, the FDA is reviewing data on Byetta and Januvia following studies that have linked both drugs to an inflammation of the pancreas called pancreatitis, and to pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

Meanwhile, other researchers have questioned the validity of the analysis identifying Avandia as a health risk. The FDA ordered an outside review of the clinical trial originally used to approve Avandia in the first place.

Two days of review ended with a divided panel. The experts comprising the panel agreed that the available information was confusing.

According to NBC News, the majority of panel members voted to ease the restrictions on Avandia’s use, but not to eliminate them entirely. The FDA usually follows the advice of its panels

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you or a loved one was diagnosed with pancreatic cancer after taking Januvia or Byetta.