Product News and Recalls

FDA taking another look at diabetes drug

The U.S. Food and Drug Administration is taking a second look at the diabetes drug Avandia, with an agency report already suggesting that the drug’s attendant risk of heart problems may not be as serious as reported.

The Philadelphia Inquirer reports that Avandia, originally approved in 1999, was once a blockbuster for GlaxoSmithKline. But a 2007 study published in the New England Journal of Medicine said the drug caused heart problems. Although the FDA did not ban the drug, it added restrictions to the official label on how it could be prescribed.

The number of Avandia prescriptions dropped from 5.1 million in 2008 to 12,600 in 2012.

Meanwhile, sales grew for newer types of diabetes medication such as Eli Lilly’s Byetta and Merck’s Januvia. Now, recent studies are linking Januvia and Byetta to a higher risk of an inflammation of the pancreas called pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

And in an unusual move, an FDA advisory committee has scheduled a hearing to reexamine a clinical trial done by Glaxo in the mid-2000s to support continued approval of Avandia. A report prepared in advance for the hearing suggests that links between the drug and heart problems may have been overstated.

According to the Inquirer, there are several possible outcomes for the hearing. The FDA can leave restrictions in place for Avandia, add more, subtract some, or withdraw approval altogether.

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.

See the story here:

http://www.philly.com/philly/business/20130604_FDA_weighs_lifting_restrictions_on_Glaxo_s_Avandia.html