Under 18s getting drug not approved for them

Hundreds of young people are being prescribed a controversial anti-depressant drug despite study results released this week which show it can place children at greater risk of suicidal behaviour.

GlaxoSmithKline (GSK), the makers of Seroxat, have published details of nine studies they carried out between 1993 and 2003 to determine whether the drug was safe.

One study found children on the drug were twice as likely to have suicidal thoughts than those on a placebo pill. The anti-depressant was also linked to a number of side effects, including insomnia, tremors and emotional irritability.

While Seroxat is not licensed in the Republic for the treatment of patients younger than 18, the Irish Medicines Board (IMB) yesterday said it estimated that around 300 young people were being prescribed the drug.

The IMB does not license the drug for use for under 18s, although a spokeswoman said doctors had the authority to prescribe any product for a patient under their care if it was considered appropriate.

GSK's decision to publish the findings of its studies on the company's website comes amid criticism and threats of legal action over claims that the firm suppressed studies on the drug.

The company, however, said in a statement that it had communicated details of the trial results as normal to the medical community over the last decade. It said it was now publishing details of the research in order to "clarify" the results of its research.

Details of the studies were apparently made available to Britain's medicines regulator and the IMB last year. This led both bodies to request that the drug makers carry a warning that it not be given to under 18s with a depressive disorder.

A GSK spokeswoman said Seroxat was not approved for use for under 18s and it was not the company's policy to promote off-label use of any of its medicines.

The practice of prescribing the drug to young people, however, was criticised yesterday by Dr Terry Lynch, an outspoken critic of the widespread use of anti-depressants.

"It does concern me. There are always situations where doctors will feel that people need such medication and they have a right to reach for it in those situations.

"But what concerns me most is that it may be reached for as a solution too quickly, before people have had their psychological and social issues fully dealt with," Dr Lynch said.

While the medical community in general appears to be divided over the use of anti-depressant drugs, the Department of Health figures indicate that prescriptions for such drugs overall have more than doubled between 1993 and 2002.

Prescription rates appear to be highest among medical card users. Around 200,000 of the one million medical card holders were prescribed anti-depressants in 2002. This compared to figures of around 100,000 among private patients. Seroxat is the fourth highest selling anti-depressant in the Republic.