Safety Concerns Of Diet Drug;Qnexa

Dr. Wayne Anderson, Medical Director of Medifast and Co-founder of Take Shape For Life appears on Fox News to talk about diet drugs and their obvious health risks…

July 2010

FDA Panel Flunks Qnexa Due to Safety Concerns

The Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has failed to endorse recommendation of the obesity drug phentermine/topiramate (Qnexa; Vivus, Inc) because of concerns about its safety….

“A lot of these potential problems are brain related — depression, anxiety, memory, cognitive, and that always makes me worry a little more than with other kinds of problems. I don’t think we have enough data to be able to say whether they are serious issues or not. I think if we had had longer follow-up I probably would have voted the other way but I just don’t feel comfortable with 1-year follow-up,” Dr. Proschan said.

Acting Chair Kenneth D. Burman, MD, from Washington Hospital Center in Washington, DC, said he hoped that his no vote will prompt further discussion with the FDA to address the safety issues, “We know that obesity is a major health problem and all efforts to address this issue should be lauded,” he said. “Qnexa does meet or exceed the agency’s requirement for efficacy. On the other hand the medication has serious potential adverse effects, including potential teratogenicity, increased suicidal ideation, cognitive issues, decreased bicarb, tachycardia, and possible renal stones. Some of these side effects are serious and could be life threatening, and they have to be weighed against the potential of a relatively modest weight loss and its long-term health benefits…”

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