From: Reuters
Published November 16, 2007 05:53 AM

Study warns on safety of Sanofi's Acomplia

By Michael Kahn

LONDON (Reuters) - Patients taking the Sanofi-Aventis anti-obesity drug Acomplia have well over double the risk of depression and anxiety, researchers said, adding to the bad news for a drug already linked to suicidal thoughts.

Danish researchers reviewed four studies featuring 4,105 patients and found that people taking 20 milligrams per day of the drug were 2.5 times more likely to discontinue treatment due to depressive disorders and three times more likely to stop because of anxiety than those who received a placebo.

The findings published in the Lancet journal follow a U.S. advisory panel decision in June that the drug should not be approved in the world's largest drugs market because it may increase suicidal thoughts and depression.

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"Taken together with the recent U.S. Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric reactions," Arne Astrup of the University of Copenhagen and colleagues wrote.

A study in the British Medical Journal on Friday also found that people taking anti-obesity drugs -- including Acomplia -- would only see "modest" weight loss with many remaining significantly obese or overweight.

Salah Mahyahou, Sanofi's head of product communication, said caution raised about who should get Acomplia was in line with the firm's efforts' to ensure the medicine is not prescribed to patients with severe depression or on anti-depressive treatment.

"We believe the meta analysis does not reveal any new data or any new evidence beyond what is already known by physicians or health authorities," he said by telephone.

SIDE EFFECTS

The researchers did not conduct the studies themselves but did what is called a meta-analysis by reviewing four separate trials of patients who received 20 gram doses of Acomplia and others who took a placebo.

They also found that while patients given Sanofi's drug lost nearly 5 kilograms more over a one-year period, the risk of serious side effects -- ranging from dry mouth to headaches to depression -- rose 40 percent.

Acomplia -- also known by the brand name Zimulti in the United States and generically as rimonabant -- is the first in a new class of drugs that switch off the same brain circuits that make people hungry when they smoke cannabis.

Its unique biochemical effect and ability to reduce several risk factors for cardiovascular disease initially led to predictions it would become a multibillion-dollar-a-year blockbuster. It recorded sales of just 21 million euros ($31 million) in the third quarter.

But the latest findings are bad news for the world's third biggest drug maker after it announced in September it planned to begin new clinical trials of the medicine as a treatment for type 2 diabetes, which is linked to obesity.

Other researchers called the Danish findings especially striking given that people with a history of serious depression or other psychiatric illnesses had been excluded from the studies.

"Their meta-analysis has raised major questions about the safety of rimonabant in obese people, who are already at an increased risk of depression," Philip Mitchell and Margaret Morris of the University of New South Wales in Australia wrote in a Lancet commentary.

(Editing by Matthew Tostevin)

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