UK tightens antidepressant rules, curbs Wyeth drug

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British health authorities tightened warnings on popular Prozac-type antidepressants on Monday, urging doctors to use them sparingly and consider non-drug interventions, such as counseling.

The Medicines and Healthcare Products Regulatory Agency, which reviewed the medicines after concerns over their safety, said there should be stronger warnings about the risk of withdrawal reactions after ending a course of treatment.

Doctors should also, in most cases, prescribe only the lowest recommended dose of selective serotonin re-uptake inhibitors, or SSRIs, and young adults should be monitored closely as a precautionary measure when being treated, it added.

No antidepressant is recommended for the initial treatment of mild depression.

Overall, the MHRA found the benefits of most SSRIs outweighed the risk of adverse drug reactions in adults but it highlighted potential problems with Wyeth’s product Efexor, use of which will in future be restricted.

New guidelines say the medicine, which is sold as Effexor in the United States, should only be prescribed by specialist doctors and patients with heart disease should not be given it at all.

The move follows evidence that Effexor is involved in a higher rate of deaths from overdose than other SSRIs and that it may affect heart function.

The MHRA appointed an expert group last year to investigate the safety of SSRIs in adults following claims they could make people feel suicidal or aggressive. Some patients also complained about disturbing withdrawal effects when they came off treatment.

BANNED IN CHILDREN

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 new review, involving examination of hundreds of clinical trials, concluded that a modest increase in the risk of suicidal thoughts and self-harm among adults taking SSRIs compared with placebo could not be ruled out.

There was, however, no clear evidence of increased risk of suicide compared with other antidepressants.

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.

Coinciding with the MHRA review, the National Institute for Clinical Excellence—which assesses the cost effectiveness of treatments—issued new guidelines on depression and anxiety, emphasizing the benefit of non-drug interventions.

For many people with mild to moderate depression, “talking” treatments such as problem-solving therapy, cognitive behavior therapy and counseling could be just as effective as drug therapy, the institute said.

The MHRA is 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 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.

Other big SSRI sellers include Pfizer Inc’s Zoloft.

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