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Of some 41,000 patients treated with rimonabant since it was launched in the U.K. in June 2006, 364 “psychiatric reactions have been reported,” the Department of Health’s Medicines and Healthcare Products Regulatory Agency (MHRA) said on July 19th.

“Amongst these, there have been 48 reports of depression, 16 reports of suicidal thoughts and one report of self-injury,” the regulatory agency said.[acomplia on line purchase]

The MHRA said evidence suggested one person in 10 taking Acomplia may develop psychiatric side effects, and “approximately one patient in every 100 may experience suicidal thoughts.”

The MHRA advised: “If you start to experience symptoms of depression while taking Acomplia, or if you are currently being treated with antidepressants, consult your doctor.

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“If you have had depression in the past but feel well on Acomplia, you should continue treatment with Acomplia and discuss your treatment with your doctor at your next routine appointment.” \

The European Medicines Agency (EMEA,acomplia on line purchase) recommended contraindicating Acomplia (rimonabant) from sanofi-aventis, in patients with ongoing major depression or who are being treated with antidepressants, because of the risk of psychiatric side effects.

Doctors in the EU have already been warned about this since June 2006 but the Agency’s Committee for Medicinal Products for Human Use (CHMP,acomplia money order) has now recommended upgrading this warning.

Acomplia has been authorised in the EU since June 2006 as an adjunct to diet and exercise for the treatment of obese or overweight adult patients. Psychiatric side effects, in particular depression, were identified as the main safety issue at the time of approval. They were reflected in the medicine’s product information as a warning that doctors should not prescribe Acomplia in patients with uncontrolled serious psychiatric conditions such as major depression.

As part of its continuous monitoring of the safety of medicines, the CHMP requested sanofi-aventis in June 2007 to submit all available information on the psychiatric side effects of Acomplia. Finalising the assessment of the available data at its 16-19 July 2007 meeting, the CHMP concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or acomplia on line purchase taking antidepressants.

The CHMP also recommended adding a warning that treatment with acomplia money order should be stopped if a patient develops depression, as well as the inclusion of additional information on the psychiatric safety of Acomplia.

Doctors will be sent a letter to inform them about the updated prescribing information. Patients and their carers should be aware of the risk of depression in patients taking Acomplia.

The CHMP recommendation will now be forwarded to the European Commission for adoption of a Decision.

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The European Medicines Agency has warned consumers that the weight loss drug Acomplia heightens the risk of suicide among those taking anti-depressants.
The agency wants stronger warnings placed on the drug to reflect that risk but has stopped short of suspending the drug.The agency says though the benefits of Acomplia outweigh its risks, it should not be used under any circumstances in patients with ongoing major depression or those who are taking antidepressants.

The panel has also called for a new warning on Acomplia’s label to state that treatment should be stopped if a patient develops depression.

Information regarding the updated information will be sent to all doctors as the agency says it is important patients and their carers are aware of the risk of depression with the drug.

The move is in line with that of an advisory panel to the Food and Drug Administration (FDA) in the U.S. which has said the product should not be approved because it may increase suicidal thinking and depression.

The FDA decision was the result of a study which found that of 120 patients taking the drug, two had committed suicide and one was considering it, while another attempted to strangle his daughter.

Since that decision drug company Sanofi has withdrawn its application to sell Acomplia in the United States and acomplia money order; it has been available under the brand name Zimulti in Europe since the middle of last year.

European officials are likely to allow the drug to remain on the market but with stricter warnings.

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Acomplia is the first in a new class of drugs that work by switching off the same brain circuits that make people hungry when they smoke cannabis and it was forecast to become a multibillion dollar blockbuster.

More than 40,000 Britons have been treated with Acomplia since last year which was lauded as a wonder drug after trials showed it could help dieters lose up to 10 per cent of their body weight and also help smokers quit.

The Medicines and Healthcare Products Regulatory Agency in the UK says to date there have been 318 cases of patients being adversely affected by Acomplia.