Britain’s medicines agency tightened warnings on popular Prozac-type antidepressants on Monday following a review of selective serotonin re-uptake inhibitors (SSRI) sparked by concerns over their safety.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said there should be stronger warnings about the risk of withdrawal reactions after ending a course of SSRI treatment and in most cases the lowest recommended dose should be prescribed.
Young adults should be monitored closely as a precautionary measure when being treated with SSRIs, it added.
The agency appointed an expert group to investigate the drugs’ safety following claims they could make people feel suicidal or aggressive. Some patients also complained about unpleasant withdrawal effects when they came off treatment.
Drugs including GlaxoSmithKline Plc’s Seroxat -- the most widely prescribed among the drug class in Britain -- were banned from use in children last year following evidence that they may increase the risk of suicides.
The review said a modest increase in the risk of suicidal thoughts and self harm for patients taking SSRIs could not be ruled out, but there was no clear evidence of increased risk of suicide compared with other antidepressants.
The MHRA is also conducting a separate investigation into whether GlaxoSmithKline, Europe’s biggest drugmaker, withheld important data from clinical studies on the suicide risk among teenagers taking Seroxat.
Seroxat, known as Paxil in the United States, used to be GSK’s biggest-selling product but it has recently declined in importance following the launch of cheap generic copies in key markets. Eli Lilly & Co has also lost patent protection on Prozac.
Drug companies argue that millions of people have been prescribed SSRIs without suffering major adverse events and that suicidal thoughts are more likely to be the result of their depression rather than the treatment.
