What is Acomplia,latest news

What is Acomplia?Acomplia is the brand name of a new prescription weight loss drug for dieters, Rimonabant, that has recently (June 28th, 2006) been approved for use by patients in the UK.

Who is Acomplia suitable for?

It is designed as a slimming aid for obese patients or overweight patients with other risk factors such as type 2 diabetes or dyslipidaemia - see BMI for the definitions of what constitutes overweight or obese. In particular, the drug reduces the risk of heart disease and type 2 diabetes. It may also help people to stop smoking, although it has not yet been licensed for this purpose.

What results can I expect?

In clinical trials, over one year 33% of patients lost more than 10% of their initial bodyweight, with nearly two thirds of patients losing over 5%. Patients were placed on a calorie controlled diet whilst on the trial, but still lost statistically significantly more weight than the control group who were only given a calorie controlled diet to follow and a placebo.

Will I regain the weight lost?

Patients who took the drug for a further year did not regain the weight lost. However, it is reasonable to assume, in the absense of any data to the contrary, that once patients stop taking the drug completely, the weight will be regained.

Are there any other benefits to taking Acomplia?

It has been shown to have a beneficial effect on blood glucose and fat levels. Specifically it raises HDL cholesterol levels (the good cholesterol).

Latest News

19th July, 2007

As expected, Sanofi Aventis has changed the labelling on Acomplia for the European Union market, to contraindicate it for patients with ongoing depressive illness, or for patients currently undergoing treatment for depression. This is because of the risk of psychiatric side effects.

These side effects have been known about, and doctors have been warned about them, since June 2006. It is just now that an upgrading of the warning has occurred following advice by the CHMP - the Committee for Medicinal Products for Human Use.

4th July, 2007

A research study, published in the July 2007 edition of “Hepatology, The Official Journal of the American Association for the Study of Liver Damage” has shown that Acomplia reduces the risk of liver damage in obese rats. Obesity in general causes many health problems, one of which is hepatic steatosis - a fatty liver. There are no other drug treatments for this condition. However, in a study where male obese rats received an oral dose of Acomplia daily for a duration of 8 weeks, treated rats had a reduced incidence of an enlarged liver and there were no incidences of hepatic steatosis. These results were more favourable than those of the control group, who recieved the same diet as the treated group but did not receive Acomplia.

20th June, 2007

German regulators have labelled Acomplia a “lifestyle” drug, meaning that state health insurance will not contribute to the cost of the drug. This means that the users of Acomplia will have to pay the full cost of the drug themselves.

18th June, 2007

Indian drug companies have launched a generic version of Acomplia.

14th June, 2007

The FDA advisory panel yesterday recommended that the FDA reject Acomplia. They were concerned about issues concerning the mental health of patients who take Acomplia, even though the drug has been approved for use in 37 countries outside the US. The FDA is not bound to follow the advice of its advisory panel, but it usually does.

However, given the decision in the US, it is likely that the EU licence for Acomplia will be reviewed. Sanofi-Aventis have stated that tests show that Acomplia brings about an increased incidence of “suicidal thoughts” and is not recommended for patients who are clinically depressed.

The European Medicines Agency (EMEA) are meeting on June 18th - 21st and will most likely discuss Acomplia, perhaps reinforcing warnings about dosing and contraindications. In theory, they could revoke the licence for the drug, but this would be an extreme move and is thought to be unlikely.

UPDATE: The EMEA are taking no action at present but will continue to review new clinical data on Acomplia, especially in patients who have psychological issues.

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