Acomplia users at Risk of Pshychiatric Disorders, page 1

Came across this story, and thought it worth a look - the weight loss pill has been linked to deaths in people suffering from depression.

Acomplia drug patients at psychiatric risk

Last Updated: 1:07am BST 20/07/2007

A weight-loss drug used by thousands of UK patients should not be taken by people on anti-depressants, a European health watchdog warned yesterday.

The European Medicines Agency (EMEA) said it was recommending that anyone taking anti-depressants or suffering ongoing major depression should not take rimonabant, which is sold under the brand name Acomplia.

About 41,000 patients in the UK have been treated with rimonabant since it was launched here in June 2006.
The Department of Health's Medicines and Healthcare products Regulatory Agency (MHRA) said it had received reports of psychiatric reactions to Acomplia in the UK.

"Three hundred and sixty-four (364) psychiatric reactions have been reported," it said. "Amongst these, there have been 48 reports of depression, 16 reports of suicidal thoughts and one report of self-injury."

It said evidence suggested one in 10 people who take Acomplia may develop psychiatric side effects.

"Approximately one patient in every 100 may experience suicidal thoughts."

Last month, a committee advising the Food and Drug Administration (FDA) in the United States voted to ban the drug because of an increased risk of suicide.
www.telegraph.co.uk.../news/2007/07/20/nweight120.xml

The RIO-North America trial was the first to produce two-year safety and efficacy data for Acomplia, and concern over possible side effects has focused on the noticeable rate of withdrawal from the trial due to depression.

Some 2.9 percent on the optimal higher dose of Acomplia had to drop out of the trial because they developed depression, compared with only 1.5 percent of those taking placebos, according to Dr. Douglas Greene, vice president for corporate and regulatory affairs for Sanofi-Aventis, developer of the drug.
www.acompliareport.com...

Yet another example of drug companies caring more about money than the welfare of those they want to peddle their drugs to.

It is unfortunate that it led to this, but Rimonabant interacts with the central nervous system which is an area of the human body that varies greatly from person to person. So, in clinical trials for such drugs results can vary greatly from one test subject to the next and results are often inconclusive. Laws governing the introduction of medications also vary from country to country and this is why Rimonabant never really made it through FDA scrutiny in the United States. For anyone knocking the FDA (which happens quite a bit on this board), they are one of the better organizations in the world for the rigorous testing and clinical information they require before medications enter the U.S. market. You can read a bit more about it here:

FDA: Rimonabant

If I remember correctly the manufacturer of Rimonabant is Sanofi-Aventis who is one of the biggest pharmaceutical companies in the world, or at least in Central Europe. Their plan for introduction of the drug into the United States failed because of the number of reports that suggested its potential harm to the nervous system and interfering with human physiology which lead to a number of mental conditions. Back when the drug was first being tested and in the trial stages, there were huge demands for the drug to enter the market. Physicians and patients were eagerly awaiting the release of Rimonabant...hands out and mouth drooling. Now, pharmaceutical companies are a business, and the key to running any successful business is to maximize profit and minimize loss. I would tend to believe that Sanofi-Aventis wanted to maximize profit on the hundreds of millions of dollars that they poured into Rimonabant; not only the money to manufacture the medication but the money to test it. Due to the huge demand for the medication by both patients and physicians the medication was pushed into the market a little early, particularly in Europe. The FDA, on the other hand, scrutinized the noted mental side effects from the medication and realized that early release of the drug into the United States would be unsatisfactory. For the FDA, I believe they were in a bind; sort of a no win situation...if it was released and side effects were noticed by patients then the patients would be screaming about why it was released early...if they didn't release it then people would be equally upset about the loss of a potentially good weight loss medication. However, the drug was approved for sale in Europe by the European Commission. Here is a bit more on the approval by Forbes Financial:

European Commission approves Acomplia

Due to the fact that results can vary greatly in patient to patient studies involving medications that interact with the central nervous system there is a grey area concerning their approval.

[edit on 20-7-2007 by Jazzerman]

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