An anti-obesity drug that has been prescribed to 97,000 people in the UK doubled the risk of psychiatric disorders in those who took it, the European Medicines Agency has found.

The EMA has decided that the benefits of the drug Acomplia - which has been licensed in Europe since June 2006 - no longer outweigh the risks, and have advised doctors to no longer prescribe the drug.

In a trial of 36,000 this summer, five of those taking the drug committed suicide, compared to only one of those taking the placebo.

Acomplia, whose active substance is rimonabant, has been available on the NHS since June this year. It works by suppressing the appetite. During clinical trials, one third of patients lost more than 10% of their initial bodyweight in a year. Nearly two thirds of patients lost over 5%.

The drug is prescribed for people who are clinically classified as obese, or those who are overweight and suffer from problems like type 2 diabetes and a high cholesterol.

Warnings about the side effects of the drug-- which can cause depression-- have been known since the drug was introduced. It is only now however, that it has been decided that these side effects make the drug too dangerous to prescribe.

Following a re-evaluation of the drug, the EMEA said that “there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients.”

The EMEA, and their UK counterpart the Medicines and Healthcare products Regulatory Agency (MHRA), have recommended that the drug is no longer prescribed, and said that those currently on the drug- thought to be about 20,000 in the UK- should consult a doctor about their treatment. The MHRA is alerting healthcare professionals about the recommendation.

The MHRA said: “Patients who may be at highest risk of psychiatric reactions cannot be identified reliably. Therefore, further restrictions on the use of this medicine would be unlikely to reduce the risk to an acceptable level.”

There are three main anti-obesity drugs prescribed in the UK- Acomplia, Sibutramine, and Orlistat. Acomplia is prescribed in for about 9% of cases, whereas Orlistat, approved by the EMEA in July 2007, is prescribed in 66% of cases.

The manufacturer of the drug, Sanofi-Aventis, said: “Sanofi-Aventis will comply with the European authorities’ request to temporarily suspend the marketing authorisation of Acomplia in obese and overweight patients and will make every effort to actively support patients and healthcare professionals in this process.”

They said that the drug had provided “significant clinical benefits to patients” and that 700,000 people worldwide had used the drug.

Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA said : "Most medicines work well and are acceptably safe and most people take medicines without suffering any side effects. The MHRA and the EMEA work together to continuously monitor the safety and quality of medicines after they have been licensed, and use a range of approaches to minimise risk.

"In the case of Acomplia these measures have not proved to be effective in clinical use.

"People can report suspected side effects of medicines to us directly through our Yellow Card Scheme. They can do this online at www.yellowcard.mhra.gov.uk or telephone 0808 100 352."

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