The Hindu : Business : Use of Glaxo drug under review

Online edition of India's National Newspaper
Tuesday, Jun 08, 2004

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Business

Use of Glaxo drug under review

By Our Special Correspondent

NEW DELHI, JUNE 7. The Centre has instituted a review on the use of Glaxo Smithkline's anti-depressant drug, Paroxetine, following a lawsuit filed in the U.S. by the New York State Attorney General alleging that the company had concealed data generated during clinical trials, which indicated that the drug could cause suicidal behaviour among children and teenagers.

Speaking to The Hindu, the Drug Controller General of India, Ashwini Kumar, said that on seeing reports about the lawsuit, his office had begun to collect all relevant details.

The matter would be looked into in detail and decisions would be taken in consultation with experts.

The drug was sold in India under different brand names such as Parotin, Parin and Pexep.

In the civil lawsuit, the New York State Attorney General, Eliot Spitzer, has claimed that the company suppressed the results of at least four different studies that showed that the drug, called Paxil in the U.S., was at best no more effective than a placebo and at the worst was harmful.

According to the lawsuit, in one case, up to 6.5 per cent of the sample taking the drug had developed suicidal tendencies, compared to 1.1 per cent in the placebo group.

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