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Officials at the prominent consumer watchdog group, Public Citizen, panned the federal government’s decision to approve a new weight loss drug, Belviq, predicting that it may eventually be recalled due to reports of heart damage.
According to a statement released by Public Citizen’s Health Research Group director, Dr. Sidney Wolfe, the FDA ignored critical safety data when they approved Belviq, an Arena Pharmaceuticals drug.
While it is the first new weight loss drug approved by the FDA in a decade, Dr. Wolfe suggested that it is going to be associated with a number of serious side effects, and that it will eventually be removed from the market like a number of other previously-approved weight loss drugs.
In April, when an FDA advisory panel was considering what requirements to impose upon companies wanting to market new weight loss drugs, Wolfe pointed out that there have been four obesity drug recalls over the past 15 years, including fen-Phen, Dexatrim/Accutrim, Meridia and drugs containing ephedra. All involved an increased risk of cardiovascular events such as strokes, hypertension and heart attacks.
Wolfe said that Belviq, which was approved this week by the FDA, would be no different. He noted that there were signs of heart valve problems in the drug’s clinical trials, and pointed out that the advisory panel could not rule out the risk of Belviq heart side effects.
His statement came as a recommendation against the use of diet drugs was published in the Annals of Internal Medicine. That report notes that the U.S. Preventative Services Task Force has determined that there is no data showing people can keep the weight off after they discontinue diet medications. When the health risks of those drugs are factored into the equation, the task force concluded that it could not recommend that anyone be prescribed or use weight loss drugs. Behavioral intervention proved to be far more effective, the task force found, and recommended that behavioral intervention be the route doctors take with patients who are obese.
It has been 13 years since the last weight loss drug, Xenical (orlistat 120mg), was approved in 1999. The lower dose Alli (orlistat 60mg) is an over-the-counter weight-loss drug that was approved in 2007. Both drugs are marketed by GlaxoSmithKline, PLC, though Xenical is manufactured by Roche.
Belviq’s approval came even as another weight loss drug, Qnexa, is under consideration for approval. That drug has been developed by Vivus Inc., and approval has been delayed amid concerns about the risk of birth defects from topiramate, an antiseizure drug contained in the new weight-loss medication, which is also the active pharmaceutical ingredient in Topamax. Last year, side effects of Topamax use during pregnancy were linked to an increased risk of cleft palate and cleft lip.