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FDA issues hold on much-debated Avandia study
WASHINGTON (AP) - Federal health officials are barring new patients from enrolling in a safety study of GlaxoSmithKline’s controversial diabetes pill Avandia, a week after a panel of experts ruled that the drug increases heart risks.
The Food and Drug Administration said it issued a “partial clinical hold” on the study to update researchers on the latest concerns about Avandia, which has been under scrutiny since 2007.
Last week a panel of experts voted that the drug appears to increase heart risks, but a majority ultimately voted to leave the drug on the market because the evidence was not definitive.
The FDA is currently reviewing the panel’s opinions and deciding what action to take.
GlaxoSmithKline said in a statement it would halt recruitment for the so-called TIDE trial and update the study’s chief investigators on last week’s meeting. Patients already in the study will be permitted to continue participating.
The London-based drugmaker agreed to conduct the trial in 2007, after safety questions about Avandia were first publicized.
The TIDE study is designed to give a definitive assessment of whether Avandia’s heart risks are greater than its chief competitor Actos.
Last week, the FDA’s panel of outside advisers voted 20-10 that the trial should continue if Avandia stays on the market.
Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, said halting enrollment in the trial was “the ethically correct thing to do.”
Nissen first drew attention to Avandia’s risks in a 2007 medical journal article estimating that patients taking Avandia were 43 percent more likely to experience heart attack than those taking other diabetes drugs or no diabetes medication. He noted that the FDA’s advisory panel specifically voted last week that Avandia increased risk of heart attacks more than Actos.
The TIDE study is supposed to enroll 16,000 patients, though safety concerns surrounding Avandia have slowed recruitment. Researchers reported last week that just 1,100 patients have volunteered for the study.
Dr. Robert Califf of Duke University, a researcher who is leading three major industry-funded diabetes studies, said there is still “tremendous uncertainty” about Avandia’s balance of risk and benefit, and that not completing the study could leave a big hole in the information needed by patients and doctors.
Califf said the FDA’s move is “a reasonable and rational step while the company gets its information together” but cautioned that it could push some current study participants to drop out.
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