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 in a report released Monday.
The report was prepared in advance of an unusual advisory committee hearing set
for later 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 something of a bind with this drug. It approved the medication in
1999, but then was criticized after a 2007 study found cardiovascular problems
in those who used it. 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, which has facilities in and around
Philadelphia, 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. The FDA
commissioner is not required to follow the advisory committee's recommendations,
but usually does.
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 following
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.
Steven Nissen, a Cleveland Clinic cardiologist who co-wrote the New England
Journal study, told The Associated Press this week that the FDA should not
"You want to take a regulatory action because it's going to benefit patients,"
he said. "I don't see how patients could possibly benefit from lifting these
In 2012, Glaxo pleaded guilty to three criminal charges and paid $3 billion in
penalties following an investigation of the company's activities in the early
part of the last decade. One of the criminal charges related to withholding
safety information about Avandia.
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