A report in the prestigious medical journal The Lancet linking diet pill Acomplia (rimonabant) to "severe adverse psychiatric events" is potentially the most damaging blow to efforts by Sanofi-Aventis to market the obesity drug since the decision earlier this year to keep it off the market in the United States.
In a study published in the Nov. 17 edition of The Lancet, scientists at the University of Copenhagen reported on their meta-analysis of four clinical trials that in part formed the basis of approval of sale of Acomplia in the European Union but not in the United States.
"Our findings suggest that 20 mg per day rimonabant increases the risk of psychiatric adverse events -- ie, depressed mood disorders and anxiety -- despite depressed mood being an exclusion criterion in these trials," the researchers concluded.
"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 adverse reactions," the researchers added.
While the European Medicines Agency (EMEA) has permitted continued sale of Acomplia in the European Union countries, Sanofi earlier this month conceded that sales have been disappointing -- and headlines generated by this Lancet study seem likely to make things worse.
Britain's Press Association, which publishes stories carried by newspapers around the UK, reported that "doctors have issued a new warning about the mental health hazards of taking weight-loss drug rimonabant. A review of trial evidence involving more than 4,000 patients found those taking the drug had a 40% higher risk of suffering 'adverse events or serious adverse events'."
The London Evening Standard ran a story headlined "Weight-loss pill taken by 40,000 'can lead to suicidal thoughts," and reported that "a weight-loss pill that has been used by 40,000 Britons may increase the risk of depression, anxiety and suicidal thoughts, scientists have warned."
The London Telegraph, in an equally alarming story, reported that "the safety of an slimming drug taken by tens of thousands of people in UK has been questioned after new research linked it to depression."
The Guardian, another UK newspaper, reported "people taking the weight-loss drug rimonabant have an increased risk of mental health problems, according to a study of more than 4,000 patients in four clinical trials."
Sanofi-aventis, developer of Acomplia, was sufficiently concerned by The Lancet report and a similar report that appeared this week in the British Medical Journal to rush out a statement on Nov. 16th responding to the stories.
"The clinical data resulting from these meta-analyses do not add any new information and are in line with the clinical trials on efficacy and safety known with rimonabant today," the Sanofi statement said. "However, the extrapolation of certain data appears to us to be the sole result of the authors’ opinion."