June 13 - Weight loss drug rimonabant can cause serious harm

* Update: The Food and Drug Administration's endocrine metabolic drugs advisory committee voted today 14 to 0 not to approve the diet drug rimonabant. *

The Food and Drug Administration (FDA) should not approve the new diet drug rimonabant (marketed as Acomplia in Europe and known as Zimulti in the U.S.) because it produces only modest weight loss and has been shown to produce serious physical and psychological adverse effects, according to Public Citizen testimony before an FDA advisory committee meeting today. The group argued that more extensive studies of the drug’s effectiveness and safety are needed to fully evaluate its benefit-to-risk ratio.

The testimony about rimonabant was prepared by Dr. Sidney Wolfe, Ben Wolpaw and Elizabeth Barbehenn, Ph.D., all of the Health Research Group at Public Citizen. Wolfe delivered the testimony to the FDA’s endocrine metabolic drugs advisory committee.

Rimonabant inhibits brain receptors involved in eating. But the drug also inhibits other areas of the brain and other organs, raising serious concerns about the drug’s toxicity.

Because the receptors are widespread in the brain, rimonabant has been shown to cause extraordinarily broad kinds of psychiatric dysfunction, in addition to increased suicidal tendencies and other depressive symptoms. A report from the European drug regulatory authority also acknowledges such adverse effects in animals as increased birth defects, impaired fetal survival, convulsions, liver toxicity, chromosomal aberrations and carcinomas.

"Because rimonabant is the first drug of its class, there is no data on its use in humans over an extended period of time," said Wolfe. "The complete lack of information about the long-term effects of this drug is a serious cause of concern."

To read the entire press release, click here.

To read the testimony, click here.

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