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Industries / Drugs & healthcare Print article | Email
UK advises against GSK's Seroxat for children
By Josephine Cumbo in London
Published: June 10 2003 12:26 | Last Updated: June 10 2003 12:26

GlaxoSmithKline suffered a blow on Tuesday when UK health regulators told doctors to stop prescribing Seroxat, the group's blockbuster anti-depressant, to under 18s and said the use of the drug by adults was also under review.

Seroxat, known as Paxil in the US, is one of the world's most widely used anti-depressants and had sales last year of 2bn ($3.3bn). Over the past year about 4m prescriptions for the drug were written, with an estimated 8,000 patients being under 18.

The new advice to doctors came after a two-week review into Seroxat and other anti-depressants by the government's Medicine's and Healthcare Products Regulatory Agency.

The review - sparked by complaints of adverse reactions in Seroxat patients - found an increase in the rate of self harm and potentially suicidal behaviour in children and teenagers under 18.

"It has become clear that the benefits of Seroxat in children for the treatment of depressive illnesses do not outweigh the risks," the agency said.

Seroxat is not currently licensed for use in children, but is often prescribed to under 18s at their doctor's discretion.

"It is therefore important that doctors, patients and parents are aware of the new advice," said Professor Gordon Duff, chairman of the Committee on Safety on Medicines.

An expert group investigating SSRIs, the class of anti-depressants known as selective serontonin retake inhibitors, which include Prozac, will now be "examining urgently" the implications of the new findings for Seroxat use in over 18s.

Richard Brook, chairman of the mental health charity MIND, which raised the concerns of Seroxat users, said: "MIND strongly believes that the decision today [Tuesday] requires us to move very quickly forward on the review of Seroxat and other SSRIs, especially given the strength of concern we've heard from people taking these drugs."

Shares in GSK were 3p lower at 12.58 in late morning trade in London.

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