Healthy Skepticism Library item: 67

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Publication type: news

Hirschler B.
Britain May Tighten Rules on Antidepressant Drugs
Reuters 2004 Dec 3

Full text:

Britain’s medicines agency is likely to tighten up guidelines on the use of antidepressant drugs following a major safety review expected to be published on Monday, people familiar with the situation said.

A spokeswoman for the Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed on Friday that the report was due “shortly” but declined to comment on its contents.

Drugs including GlaxoSmithKline Plc’s Seroxat/Paxil — the most widely prescribed among the drug class of selective serotonin re-uptake inhibitors (SSRIs) in Britain — were banned from use in children last year following evidence that they may increase the risk of suicides.

Since then UK regulators have launched a probe into how adults respond to SSRIs.

The Committee on Safety of Medicines, an advisory body to the MHRA, was asked to estimate the risk of suicide, suicidal thoughts, non-fatal overdose and self-laceration in patients diagnosed with depression taking SSRIs.

There are also worries that some people suffer unpleasant withdrawal effects when they try to come off treatment.

Britain has taken the lead in reviewing the safety of SSRIs following reports that a few depressed patients turn violent or suicidal after starting medication.

Industry analysts believe the MHRA may look critically at the entire SSRI drug class — which also includes Eli Lilly & Co’s Prozac- – in the light of current public concerns about drug safety, highlighted by the global withdrawal of Merck & Co Inc’s painkiller Vioxx in September.

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.

The MHRA spokeswoman said this investigation, which could lead to criminal charges, was still continuing.

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 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.