FDA Warns About Acomplia, The Weight Loss Pill

By John Wolper
17:45, June 12th 2007
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FDA Warns About Acomplia, The Weight Loss Pill

A diet-pill developed by Sanofi-Aventis may trigger suicidal behavior and suicidal behavior and other psychological side effects in some patients, according to an online review posted by FDA.

The drug, called Acomplia, was already approved in Europe, but FDA is still analyzing the drug. Its final decision will be announced July 27.

Acomplia is a brand name for rimonabant affects the level of anandamide and it was introduced summer in Britain as a drug that might help a person lose 10 percent of their weight within a year by interacting with anandamide to reduce appetite.

After evaluating the clinical studies submitted by Sanofi Aventis FDA said patients

taking Acomplia daily showed significant weight loss after two years,but the US agency warned about an increased rate of psychiatric adverse events.

Sanofi Aventis reported one patient committing suicide and eight having suicidal thoughts. Among patients taking a fake pill, the French drug maker reported two suicide attempts and five instances of suicidal thoughts.

Last year a study conducted at the Vanderbilt University Medical Center in Nashville, Tenn., suggested that a key chemical affected by the drug rimonabant is needed for embryos to implant normally in the womb.

Anandamide governs the development and implantation of the embryo and researchers said even a small variation in the level of anandamide might have disastrous consequences.

Last year FDA rejected the company's application and said it needed more information on Acomplia's psychiatric side effects. If FDA approves the drug it will be sold on the US market under the brand name Zimulti.



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