Rimonabant Side Effects

Acomplia's most common side effects are nausea, dizziness and diarrhea. The drug also can affect mood. Depression and anxiety, while not common, did occur at higher rates than on a placebo in tests.

Some 2.9 percent on the optimal higher dose of Acomplia (Rimonabant/Zimulti) had to drop out of the trial because they developed depression, compared with only 1.5 percent of those taking placebos.

But earlier this fall, European researchers reporting on results of a quality of life study among patients receiving either Acomplia or placebo said two patients suffered amnesia while taking Acomplia -- a condition that apparently cleared up after the drug was stopped.

They also reported mood disorders (such as depression) were higher among patients taking Acomplia.

These trial results suggest that while most patients do well on Acomplia, there are likely to be some who do not. And if a side effect like depression shows up in only one in 100 patients, that could translate into a huge number of people if millions of people are taking the drug.

FDA seems certain to want a lot of data on any potential risk factors in the use of a new drug that affects the brain.

While Sanofi-Aventis is hoping the drug can be on the market in the United States in 2006, some experts think FDA concern over side effects may make this timetable a bit optimistic.

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