Britain’s Committee on Safety of Medicines advised doctors on Thursday not to prescribe higher doses of GlaxoSmithKline Plc’s antidepressant Seroxat, which is sold as Paxil in the United States.
Committee chairman Gordon Duff said in a statement that increasing the dose beyond recommended levels did not appear to increase the efficacy of the drug and might be detrimental in some cases.
Officials estimate that 17,600 out of the 110,300 Britons who received the drug for the first time in 2003 were prescribed more than the recommended daily starting dose of 20 mg.
“There is no evidence from clinical trials that increasing the dose above the recommended dose increases efficacy,” Duff said in an alert to health professionals.
He added: “If your patient is being treated at higher than the recommended dose and is not doing well then a change of treatment should be considered.
“The adverse events that occur soon after starting therapy may be difficult to distinguish from the underlying condition. There is evidence that increasing the dose in this situation may be detrimental.”
Higher doses could increase the risk of side effects such as tremor, officials said.
The latest advice follows a review of clinical trial data on the use of the drug in adults. It follows advice from the same committee last year not to prescribe Seroxat to children and adolescents.