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Acomplia drug patients at psychiatric risk
Last Updated: 1:07am BST 20/07/2007
A weight-loss drug used by thousands of UK patients should not be taken by people on anti-depressants, a European health watchdog warned yesterday.
The European Medicines Agency (EMEA) said it was recommending that anyone taking anti-depressants or suffering ongoing major depression should not take rimonabant, which is sold under the brand name Acomplia.
About 41,000 patients in the UK have been treated with rimonabant since it was launched here in June 2006.
The Department of Health's Medicines and Healthcare products Regulatory Agency (MHRA) said it had received reports of psychiatric reactions to Acomplia in the UK.
"Three hundred and sixty-four (364) psychiatric reactions have been reported," it said. "Amongst these, there have been 48 reports of depression, 16 reports of suicidal thoughts and one report of self-injury."
It said evidence suggested one in 10 people who take Acomplia may develop psychiatric side effects.
"Approximately one patient in every 100 may experience suicidal thoughts."
Last month, a committee advising the Food and Drug Administration (FDA) in the United States voted to ban the drug because of an increased risk of suicide.
The RIO-North America trial was the first to produce two-year safety and efficacy data for Acomplia, and concern over possible side effects has focused on the noticeable rate of withdrawal from the trial due to depression.
Some 2.9 percent on the optimal higher dose of Acomplia had to drop out of the trial because they developed depression, compared with only 1.5 percent of those taking placebos, according to Dr. Douglas Greene, vice president for corporate and regulatory affairs for Sanofi-Aventis, developer of the drug.