Philadelphia Inquirer (PA)
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 loosen restrictions.
"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 regulatory restrictions."
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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