People given 20 mg of Acomplia per day along with dietary counseling lost an average of 9.5 pounds after 1.5 years compared to a weight loss of 1.1 pounds for those given a placebo according to a new study called the STRADIVARIUS study. The study involved 839 patients at 112 centers in North America, Europe, and Australia. 

“Significant psychiatric and gastrointestinal tract adverse effects were observed [ in people given 20 mg of Acomplia ( rimonabant ) ] but were usually mild or moderate in severity,” noted the authors of the STRADIVARIUS study that involved 839 patients at 112 centers in North America, Europe, and Australia.

A total of 43.4 percent of those given Acomplia ( rimonabant ) reported psychiatric side effects versus 28.4 percent of those given a placebo.

“These adverse events consisted primarily of an increase in anxiety and depression,” the authors noted.

Severe psychiatric adverse effects, defined as major depression, thoughts of suicide, or attempted or successful suicide occurred with 4.7 percent of patients given 20 mg of Acomplia ( rimonabant ) per day versus 3.8 percent of those given a placebo according to the STRADIVARIUS study that involved 839 patients at 112 centers in North America, Europe, and Australia.

“A single patient in the placebo group attempted suicide, and a single patient in the rimonabant [ Acomplia ] group successfully completed suicide,” the paper noted.

Gastrointestinal side effects were reported by 33.6 percent of patients given 20 mg of Acomplia ( rimnoabant ) per day versus 17.8 percent of those given a placebo according to the STRADIVARIUS study that involved 839 patients at 112 centers in North America, Europe, and Australia. 

A total of 17.5 percent of patients given 20 mg of Acomplia ( rimnoabant ) per day dropped out of the study due to side effects versus 7.5 percent of those given a placebo according to the STRADIVARIUS study that involved 839 patients at 112 centers in North America, Europe, and Australia. 

Acomplia (rimonabant) causes an average weight loss of 10.3 pounds more than placebo according to an analysis by researchers from the University of Alberta in Edmonton, Alberta, Canada.

Side effects that have been reported with Acomplia (rimonabant) according to an analysis by Arnie Astrup and others from the University of Copenhagen in Frederiksberg, Denmark include:

• irritability
• insomnia
• stress
• nervousness
• panic attacks
• agitation
• nightmare
• abnormal dreams

Psychiatric side effects such as depression and anxiety have been reported with 26 percent of patients given Acomplia (rimonabant) compared to 14 percent of those given a placebo according to an analysis by Arnie Astrup and others from the University of Copenhagen in Frederiksberg, Denmark.

This is despite the fact that “[all of] the included trials excluded patients with existing depression, or those with a history [of depression],” as Astrup noted.

Nine percent of patients given 20 mg of Acomplia (rimonabant) required anti-anxiety medication or sleep medication compared to 4 percent of those given a placebo according to an analysis by Arnie Astrup and others from the University of Copenhagen in Frederiksberg, Denmark.

Five percent of patients given 20 mg of Acomplia (rimonabant) required anti-depressant medication compared to 3 percent of those given a placebo according to an analysis by Arnie Astrup and others from the University of Copenhagen in Frederiksberg, Denmark.

This is despite the fact that “[all of] the included trials excluded patients with existing depression, or those with a history [of depression],” Astrup noted.

Three percent of patients given Acomplia (rimonabant) dropped out of studies due to depression compared to 1.4 percent given a placebo according to an analysis by Arnie Astrup and others from the University of Copenhagen in Frederiksberg, Denmark. This means that dropouts due to depression are 2.5 times as likely with Acomplia (rimonabant) than with placebo.

This is despite the fact that “[all of] the included trials excluded patients with existing depression, or those with a history [of depression],” Astrup noted.

One percent of patients given Acomplia (rimonabant) dropped out of studies due to anxiety compared to 0.3 percent given a placebo according to an analysis by Arnie Astrup and others from the University of Copenhagen in Frederiksberg, Denmark. This means that dropouts due to depression are 3 times as likely with Acomplia (rimonabant) than with placebo.

There have been two suicides in patients given Acomplia (rimonabant) in obesity studies so far according to an analysis by Arnie Astrup and others from the University of Copenhagen in Frederiksberg, Denmark. One patient was taking 20 mg, while the other patient was taking 5 mg.

This is despite the fact that “[all of] the included trials excluded patients with existing depression, or those with a history [of depression],” Astrup noted.

Here is a story posted in one of the Discussion Forums about weight loss with Acomplia. 

Evidence from the United Kingdom suggests that Acomplia (rimonobant), also known as Zimulti, causes psychiatic side effects in roughly one of 10 people who take it and suicidal thoughts in approximately one out of 100.

Yesterday, an FDA advisory committee recommended that the U.S. Food and Drug Administration (FDA) not approve Acomplia (rimonabant) because of concerns about an increased risk of suicide and psychiatric problems associated with the drug. The FDA will makes its final decision on July 26th, 2007.

Acomplia (rimonabant) reduces appetite by blocking a receptor called the cannabinoid-1 receptor. Stimulation of these and other receptors help to protect against anxiety, phobias, depression and posttraumatic stress disorders. Stimulation of these receptors may also protect against neurotoxicity and some forms of epilepsy. Therefore, drugs that block this receptor, such as Acomplia (rimonabant), should not be used carefully and monitored closely in patients with anxiety, depression, epilepsy and neurodegenerative disorders according to the U.S. Food and Drug Administration (FDA) briefing document about the drug. 

Acomplia (rimonabant) increased the need for antidepressant drugs according to the U.S. Food and Drug Administration (FDA) briefing document about the drug. Antidepressant were prescribed for 4.8 percent of patients on 20 mg of Acomplia versus 2.9 percent of patients on placebo.

Acomplia (rimonabant) increased the need for anti-anxiety drugs and sleeping pills according to the U.S. Food and Drug Administration (FDA) briefing document about the drug. These drugs were prescribed for 8.5 percent of patients taking 20 mg of Acomplia versus 4.1 percent of patients on placebo.

Acomplia (rimonabant) increases the risk of insomnia according to the U.S. Food and Drug Administration (FDA) briefing document about the drug. Insomnia occurred in 5.4 percent of people given 20 mg per day compared to only 3.3 percent of people given a placebo.

Acomplia (rimonabant) doubles the risk of anxiety according to the U.S. Food and Drug Administration (FDA) briefing document about the drug. Six (6) percent of those given 20 mg per day reported anxiety compared to only 2.5 percent of people given a placebo.

Acomplia (rimonabant) increases the risk of irritability which occurred in 1.9 percent of people given 20 mg per day versus 0.6 percent of people given a placebo according to the U.S. Food and Drug Administration (FDA) briefing document about the drug.

Acomplia (rimonabant) increases the risk of psychiatric symptoms according to the U.S. Food and Drug Administration (FDA) briefing document about the drug. Twenty-six (26) percent of those given 20 mg per day had psychiatric symptoms compared to 14 percent of people given a placebo. Psychiatric symptoms include things like depression, anxiety, insomnia, nervousness, panic attacks, etc.

Acomplia (rimonabant) increases the risk of depression according to the U.S. Food and Drug Administration (FDA) briefing document about the drug. Nine (9) percent of those given 20 mg per day reported depression compared to 5 percent of people given a placebo.

The most frequently reported side effects reported from patients taking Acomplia (rimonabant) in the 30 countries where the drug is already approved and being sold include nausea, diarrhea, vomiting, anxiety, depression, insomnia, dizziness, headache, unusual skin sensations, tremor, sleepiness, amnesia and difficulty with attention according to the U.S. Food and Drug Administration (FDA) briefing document about the drug.