Here is an interesting post from “JohnTall”. I am posting it here so that more people will see it.

“Nearly two years ago I posted a note detailing my experience with Taranabant.  In that post I fudged my actual weights for concern that Merck might be able to identify me and end my participation in the trial.  Since then Merck has pulled the plug on Taranabant and I am no longer concerned about them knowing that I am posting.

My actual experience was that I started at 244 pounds and I lost to 183 in 101/2 months (61 pounds lost).  I then slowly regained 9 pounds to 192 and that was my weight when I left the study in December of 2007. I was in the study for 27 months.”

The “benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union” according to a recommendation by the European Medicines Agency (EMEA) to French drugmaker Sanofi Aventis on October 23rd, 2008.

The European Medicines Agency is based in London and regulates treatments in the 27 nations of the European Union.

The EMEA has determined that Acomplia doubles the risk of psychiatric disorders such as anxiety, depression, panic attacks and “suicidal ideation”.

The drug has been taken by more than 700,000 people worldwide.

Acomplia was linked to 5 deaths and 720 adverse drug reactions in Britain in the past two years according to a report in June 2008.

The drug has never been approved for sale in the U.S., but has been available in the EU since June 2006.

Because of this, it is likely that it will never be approved for sale in the U.S.

“Sanofi-Aventis [the drug company that makes Acomplia] had long rejected concerns over [Acomplia’s] psychiatric side- effects, but failed to win approval for it from the US Food & Drug Administration,” according to the Financial Times.

“Warnings to patients on the drug’s use have been strengthened several times since its launch in Europe in 2006.”

“The company said it ‘believes that Acomplia will remain an important therapeutic answer to a highly prevalent and increasing unmet medical need’, and pledged to continue studies on its use for patients with diabetes and at risk of cardiovascular disease.”

[The European Medicines Agency’s (EMEA’s) Committee for Medicinal Products for Human Use (CHMP)] noted, that the effectiveness of Acomplia in clinical practice is more limited than was expected on the basis of the clinical trials, because available data indicate that patients generally take Acomplia only for a short period,” according to a press release from the European Medicines Agency which recommended sales of Acomplia be suspended in Europe.

“Acomplia has been authorised in the European Union since June 2006 and is marketed in 18 EU Member States” which include “Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Lithuania, Malta, the Netherlands, Slovakia, Spain, Sweden and the United Kingdom” according to a Question and Answer document from the European Medicines Agency.

Acomplia (rimonobant) has been cited in 5 deaths and 720 adverse drug reactions in the UK according to figures published on June 3rd, 2008 by the Medicines and Healthcare products Regulatory Agency (MHRA).

One person on the drug committed suicide. Another person died from an infection, while three others died from heart attacks.

The European Union approved Acomplia in 2006.

“Depressive reactions may occur in up to 10% of patients treated with [Acomplia] rimonabant,” notes a report from the UK’s Medicines and Healthcare products Regulatory Agency.

“Rimonabant is [ should not be used by ] patients with ongoing major depression or those taking antidepressants.”

“mportant risks that were identified during clinical development were depressive disorders, anxiety, sleep disorders, and sensory neurological disturbances.”

Acomplia (rimonabant) can cause depression in 10 percent of patients who take it. One-third of these cases occur within the first week, and nearly one-half within the first two weeks notes a report from the UK’s Medicines and Healthcare products Regulatory Agency.

As of January 2008 there had been 15 reports of paranoia caused by Acomplia (rimonabant) according to a report from the UK’s Medicines and Healthcare products Regulatory Agency. Some, but not all, cases were in association with depression.

The most common adverse reactions associated with Acomplia (rimonabant), notes a report from the UK’s Medicines and Healthcare products Regulatory Agency, include:

• Psychiatric disorders (depression, anxiety, nervousness, irritability, sleep disorders, parasomnias where a patient is aroused during sleep and caught between being awake and a sleep)
• Nervous-system disorders (memory loss, dizziness, hypoesthesia (reduced sense of touch or sensation), paraesthesia (tingling, pricking, or numbness of a person’s skin))
• Gastrointestinal disorders (nausea, diarrhoea, vomiting)
• General disorders (fatigue, asthenia (a feeling of weakness))
• Skin and subcutaneous disorders (itching, sweating)

Sales for Acomplia (rimonabant) in 2007 totaled 79 million euros which is approximately $122 million.

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.