Two members of an expert panel that recommended the Food and Drug Administration approve a fish-oil-based heart drug, Vascepa, said recently released data would have led them to reconsider their votes.
The concern stems from the suggestion that a substantial benefit the drug showed in a large clinical trial might have been in part due to harm caused by the placebo it was compared to in the study. A new analysis published in the medical journal Circulation on June 28 indicated that in the group that received the placebo, which contained mineral oil, volunteers had blood test results that might indicate heightened risk of heart attacks and strokes.
The experts’ comments raise concerns not only about the use of one drug, but about processes at the FDA and the future of fish-oil-derived medicines as heart treatments. They are a further headache for the drug’s maker, Amarin, which is also facing generic competition in the U.S. for Vascepa, its only product.
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