FDA Panel Rejects Vivus’ Weight Loss Pill Qnexa
July 19th, 2010 - 8:34 pm ICT by Pen Men At WorkJuly 19, 2010 (Pen Men at Work): According to the latest reports, the FDA panel has rejected Qnexa, the anti-obesity pill from Vivus Inc, which was in the final stages of the FDA approval. The drug got a 10-6 vote by the panel indicating that the drug if taken for over a long period can be risky.
This new drug was expected to lower down the obesity cases in America. The drug Qnexa is supposed to contain the anti-seizure medicine Phentermine and Topamax. Taste of food is altered by Qnexa and boosts metabolism. In fact, the results have indicated that the drug can reduce body weight by almost 15%.
The advisory committee has expressed its major concerns on the use of this drug. They said it may lead to birth defects, heart risks and psychiatric problems. There is no magic pill to diet, says a physician and suggests the patients to practice portion control.
Dr. Larry Gordon of Aspirus Hospital in Wittenberg says, “You will easily lose weight if you lose more calories you take in a day. So, I don’t prescribe most weight loss drugs as a physician.”
Kenneth Burman of the panel said, “The drug may cause suicidal thoughts, memory lapses, birth defects and also heart palpitations. Some of the side effects of the drug are very serious and mere weight loss cannot be more important than this.”
By the end of this October, FDA will give its final decision on its approval of Qnexa.
This decision of FDA is an alarming call for some other pharmaceutical companies, which plan to get their anti-obesity pill evaluated by the FDA in the next few months.
Vivus has been reportedly asked to conduct one more study with 10000 patients to get an approval from FDI, which might cost around $150 million.
Well, the FDI has definitely taken an appreciative step because life with obesity is at least better than that with other serious side effects!
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Tags: birth defects, burman, dr larry, fda approval, fda panel, fdi, heart palpitations, heart risks, magic pill, memory lapses, men at work, pen men, pharmaceutical companies, portion control, psychiatric problems, qnexa, suicidal thoughts, topamax, vivus inc, weight loss drugs