Drugs Giant Attacked Over Seroxat Secrecy

HEALTH regulators have criticised drugs firm Glaxosmithkline (GSK) for withholding information over the risk of suicide relating to one of its anti-depressant drugs.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said yesterday it remained concerned that GSK failed to raise the alarm earlier over the side-effects of Seroxat.

Government prosecutors have ruled that there is no realistic prospect of getting a conviction over the issue.

But new legislation ensuring drugs companies pass on results of clinical trials promptly is to be introduced, Public Health Minister Dawn Primarolo told Parliament.

Seroxat is the most frequently-prescribed anti-depressant in the UK, but there have been complaints that it triggers suicidal feelings in some patients.

The MHRA launched an investigation into GSK in May 2003 over allegations that it knew of the drug’s dangers for several years but failed to pass on the information.

Data from an earlier clinical trial showed Seroxat was not effective in treating under-18s and had in some cases triggered a higher risk of suicidal behaviour.

Once the results were made known, the watchdog immediately warned doctors of the side effects.

Announcing the results of the subsequent investigation into GSK, Professor Kent Woods, chief executive of the MHRA, said: “I remain

concerned that GSK could and should have reported this information earlier than they did.

“All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.”

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