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U.S. panel splits on Abbott diet drug ban
Sep 17, 10 FDA warningsA U.S. advisory panel was divided over whether to recommend banning Abbott Laboratories’ controversial weight-loss drug on Wednesday, although most agreed that the drug’s heart risk cast a shadow on its future use.
Eight of the 16 members of the U.S. Food and Drug Administration’s panel of outside advisers urged withdrawing Meridia, saying the potential for heart attacks and stroke outweighed any benefits of minor weight loss. Six urged restricted sales along with a strong “black box” warning, while two others said the warning and patient monitoring was enough.
The move places the fate of Meridia, which is expected to generate $30 million in U.S. sales this year, squarely at the feet of the FDA.
The regulator is struggling with how to handle Meridia amid a new crop of prescription diet drugs that many had hoped would be safer but may carry their own concerns.
FDA panelists said at the meeting there was just not enough evidence to support the benefits of Meridia, which was approved in 1997.
“I have yet to see any of the positive benefit of the weight loss with this drug,” said panelist Lamont Weide, head of endocrinology at Truman Medical Centers in Kansas City, Missouri.
The FDA will weigh the panel’s advice as it makes its final decision on Meridia, which already saw sales in Europe halted.
Before the panel’s vote, Abbott shares closed up less than one percent at $51.66.
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ADELPHI, Maryland (Reuters)
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