The Malta Independent 2 September 2026, Wednesday
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UK Medicines watchdog

Malta Independent Sunday, 10 October 2004, 00:00 Last update: about 13 years ago

The Panorama programme claims that past trial results on the drug contain evidence it may increase the risk of suicide in young adults.

The programme also claims that the trials had evidence that the drug can leave a quarter of users addicted, while rapid increases in its dosage can cause serious side effects.

Panorama alleges some of the evidence could have been spotted earlier by the body responsible for monitoring medicines, the Medicines Healthcare products Regulatory Authority (MHRA).

The MHRA adamantly denies the allegations while Seroxat’s manufacturer, GlaxoSmithKline, said the drug’s effectiveness had been demonstrated in clinical trials involving more than 24,000 people, the BBC said.

Richard Brook, head of the mental health charity Mind, told Panorama that he had “little confidence” in the way drugs were being licensed.

He stepped down from the MHRA earlier this year, but had previously served on a group which reviewed the safety of anti-depressants. This gave him access to confidential clinical trial information on Seroxat.

Nevertheless, Sir Alasdair Breckenridge, chairman of the MHRA, said there was no evidence the drug made adults suicidal.

He told the BBC: “There is no other agency which has kept these agents, these drugs under such constant and careful review since 1990 as we have, and we will continue to do so in the interests of public health.”

And a statement from GlaxoSmithKline to the broadcaster said: “The effectiveness of Seroxat has been demonstrated in clinical trials involving more than 24,000 people and through its use in tens of millions of patients over more than a decade.

“As with all important medicines, Seroxat and other SSRI anti-depressants can cause side effects in some people.

“Information about these is provided to doctors and patients via regulatory-approved labelling and patient leaflets, and is updated as we learn more from clinical trials and the monitoring of patients world-wide.”

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