FDA: Diabetes drug may cause fewer problems than thought

Philadelphia Inquirer

PHILADELPHIA

The controversial diabetes drug Avandia, made by GlaxoSmithKline, might not cause as many heart problems as was earlier thought, the U.S. Food and Drug Administration said Monday.

The report was prepared in advance of an unusual advisory committee hearing set for this week to re-examine a clinical trial called Record done by Glaxo in the mid-2000s to support continued approval of the medication.

The FDA is in a bind with this drug. It approved the medication in 1999, but then was criticized after a 2007 study found cardiovascular problems in users. The agency did not pull the drug, but added to the official label in 2007 restrictions on how it could be prescribed. In 2010, the FDA requested that London-based Glaxo do more to prove safety.

This week’s hearing is meant to review those efforts. FDA can leave current restrictions in place, add more, subtract some, or withdraw approval. The FDA report hastened to add that no conclusions have been drawn.

Avandia was one of Glaxo’s attempts to meet the medical needs of the exploding population of Type 2 diabetics.

But after $3.2 billion in sales in 2006, the bottom fell out after publication of a May 2007 study in the New England Journal of Medicine that said Avandia caused heart problems. Doctors wrote 5.1 million prescriptions in 2008 but only 12,600 in 2012, according to the FDA report.