Study warns on safety of Sanofi's Acomplia

Study warns on safety of Sanofi's Acomplia
A logo of pharmaceutical company Sanofi Aventis is seen in Ambares near Bordeaux, southwestern France, September 20, 2006. Patients taking the Sanofi-Aventis (Regis Duvignau/Reuters)LONDON (Reuters) - Patients taking the Sanofi-Aventisanti-obesity drug Acomplia have well over double the risk ofdepression and anxiety, researchers said, adding to the badnews for a drug already linked to suicidal thoughts.
Danish researchers reviewed four studies featuring 4,105patients and found that people taking 20 milligrams per day ofthe drug were 2.5 times more likely to discontinue treatmentdue to depressive disorders and three times more likely to stopbecause 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 beapproved in the world's largest drugs market because it mayincrease suicidal thoughts and depression.
"Taken together with the recent U.S. Food and DrugAdministration finding of increased risk of suicide duringtreatment with rimonabant, we recommend increased alertness byphysicians to these potentially severe psychiatric reactions,"Arne Astrup of the University of Copenhagen and colleagueswrote.
A study in the British Medical Journal on Friday also foundthat people taking anti-obesity drugs -- including Acomplia --would only see "modest" weight loss with many remainingsignificantly obese or overweight.
Salah Mahyahou, Sanofi's head of product communication,said caution raised about who should get Acomplia was in linewith the firm's efforts' to ensure the medicine is notprescribed to patients with severe depression or onanti-depressive treatment.
"We believe the meta analysis does not reveal any new dataor any new evidence beyond what is already known by physiciansor health authorities," he said by telephone.
SIDE EFFECTS
The researchers did not conduct the studies themselves butdid what is called a meta-analysis by reviewing four separatetrials of patients who received 20 gram doses of Acomplia andothers who took a placebo.
They also found that while patients given Sanofi's druglost nearly 5 kilograms more over a one-year period, the riskof serious side effects -- ranging from dry mouth to headachesto depression -- rose 40 percent.
Acomplia -- also known by the brand name Zimulti in theUnited States and generically as rimonabant -- is the first ina new class of drugs that switch off the same brain circuitsthat make people hungry when they smoke cannabis.
Its unique biochemical effect and ability to reduce severalrisk factors for cardiovascular disease initially led topredictions it would become a multibillion-dollar-a-yearblockbuster. It recorded sales of just 21 million euros ($31million) in the third quarter.
But the latest findings are bad news for the world's thirdbiggest drug maker after it announced in September it plannedto begin new clinical trials of the medicine as a treatment fortype 2 diabetes, which is linked to obesity.
Other researchers called the Danish findings especiallystriking given that people with a history of serious depressionor other psychiatric illnesses had been excluded from thestudies.
"Their meta-analysis has raised major questions about thesafety of rimonabant in obese people, who are already at anincreased risk of depression," Philip Mitchell and MargaretMorris of the University of New South Wales in Australia wrotein a Lancet commentary.
(Editing by Matthew Tostevin)