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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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