Federal regulators have asked GlaxoSmithKline to stop enrolling new patients for a clinical trial of its controversial diabetes drug Avandia, while they review whether the drug should be pulled off the market.
Patients already enrolled in the so-called TIDE trial can continue to participate, but GSK announced today it will stop adding new patients.
In North Carolina, the only site participating in the TIDE trial is Duke University Medical Center, with Dr. Mark Feinglos as the principal investigator. Feinglos' office referred calls to a Duke spokesman, who wasn't immediately available.
Wake Forest University Baptist Medical Center in Winston-Salem recently pulled out of the safety study because researchers there were having trouble recruiting patients.
An outside panel of Food and Drug Administration advisors last week recommended that Avandia, which has been linked to health risks, stay on the market. But the panel also said that the drug should come with tougher restrictions and warnings because it can cause heart problems.
GSK is collecting additional clinical trial data to prove that Avandia is safe. The FDA is reviewing the panel's recommendations.
“This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory committee and the committee’s recommendations,” said Dr. Ellen Strahlman, GSK’s chief medical officer, in a prepared statement. “We believe that Avandia is an important treatment option for patients with type 2 diabetes."
The FDA approved Avandia in 1999 and annual sales peaked at $3 billion in 2006. The following year a report linked the drug to an increased risk of heart attacks.
British drugmaker GSK's North American headquarters is in Research Triangle Park and the drug is packaged at its factory in Zebulon.