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Dec. 7, 2010 
FDA Must Not Approve Another Dangerous Weight Loss Drug

Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

 An advisory committee for the Food and Drug Administration (FDA) will weigh approval of another weight loss drug today – and the agency must reject it.

 The diet pill Contrave is the latest in a long line of dangerous and, ultimately, failed weight loss drugs. All of the following drugs, once approved for weight reduction, had severe cardiovascular side effects and were later either banned or de-listed for weight loss: thyroid hormone, amphetamine, fenfluramine/dexfenfluramine (also known as fen-phen), phenlylpropanolamine (PPA), ephedra and sibutramine (also known as Meridia).

 Contrave, manufactured by Orexigen Therapeutics, has shown to worsen key cardiovascular risk factors, including increased blood pressure, heart rate and palpitations, which nullify the cardiovascular benefit of weight loss in these patients.

 Additionally, the drug is expected to cause seizures. With millions of new people likely to receive this drug, if approved, this could represent an enormous burden of new disease.

 To further increase the cardiovascular and other health risks of these obese patients – who are already vulnerable to cardiovascular disease – is unacceptable. The FDA advisory committee and the agency as a whole should reject the approval of Contrave. The fact that one of its ingredients, bupropion, was previously known to cause increased blood pressure – an unequivocal risk factor for heart attacks and strokes – makes the attempt to study and approve this drug unethical.

 To read the full remarks presented to the FDA advisory committee on Contrave, visit: http://www.citizen.org/hrg1922.

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