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Feb 18

FDA: Vivus Weight Loss Drug Effective But Has Safety Concerns

Long Term Weight Loss Comments Off on FDA: Vivus Weight Loss Drug Effective But Has Safety Concerns

By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The Food and Drug Administration said Vivus Inc.'s ( VVUS) obesity drug Qnexa was effective at helping people lose weight but raised concerns about possible long-term side effects such as birth defects and an unknown impact on the heart.

Qnexa is being reviewed by the FDA for a second time after previously being rejected by the agency in 2010. The agency posted a review of Qnexa to its website Friday in advance of an advisory panel meeting on Wednesday. The review of the drug includes two-year clinical data rather than one year's worth of data that was reviewed in 2010.

Qnexa will face the agency's endocrinologic and metabolic drugs advisory committee, which is made up of non-FDA medical experts. The panel is being asked to vote on and discuss a series of questions including whether the "overall benefit-risk assessment" supports approval of Qnexa. The FDA usually follows the advice of its panels but isn't required to.

In 2010 the FDA rejected Qnexa and asked Vivus for an assessment of the drug's potential to cause birth defects and for evidence that the product doesn't increase the risk for major adverse cardiovascular events.

On Friday, the FDA said Qnexa resulted in "significant" weight loss after the first year of treatment with Qnexa, but noted that patients regained some weight in the second year of the studies. The agency also raised the same concerns as it did in 2010 about a small increase in heart rate and a risk of birth defects.

Other studies of one of Qnexa's ingredients topiramate have suggested an increased risk of birth defect. The FDA said exposure to topiramate in pregnancy "is likely to be associated with a two- to fivefold increased prevalence of oral clefts," a defect of the mouth that can be later treated with surgery.

Vivus initially proposed limiting use of the drug to men, as well as women of nonchild-bearing age. But Vivus said the FDA asked the company to develop a plan to limit use by pregnant women. Vivus, in a document also posted to the FDA's website, said Qnexa produces durable weight loss, which "can be expected to contribute greatly toward ameliorating some of the consequences of obesity and weight-related [illnesses]."

Qnexa is a controlled-release formulation that combines low doses of two older drugs: the stimulant phentermine, which cuts appetite, and topiramate, which increases the sense of feeling full. Topiramate is sold under the brand name Topamax by Johnson & Johnson (JNJ) to treat migraines and seizures.

The development of obesity compounds has been a tough area for companies since the fen-phen drug combination was taken off the U.S. market in 1997 after one of the medication's components was linked to heart-valve damage. Abbott Laboratories (ABT) removed its weight-loss drug Meridia from the U.S. market in 2010 amid concerns about the drug's risk of side effects like heart attack and stroke.

-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

(END) Dow Jones Newswires 02-17-120910ET Copyright (c) 2012 Dow Jones & Company, Inc.

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FDA: Vivus Weight Loss Drug Effective But Has Safety Concerns

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