SSRI antidepressants must carry warnings that people might become suicidal while taking them, US drug regulator says

March 28, 2004

Prozac, Seroxat and other SSRI antidepressants must carry warnings that children and adults might become suicidal while taking them, the American drug regulator said last week

The Guardian newspaper reported that the Food and Drug Administration (FDA) stopped short of stating that the drugs can cause some people to want to kill themselves, but made it clear it was a possibility.Doctors should be aware that if a patient's depression appeared to get worse, it "could be due to the underlying disease or might be a result of drug therapy", the FDA said.

David Healy, the consultant psychiatrist from north Wales who raised concerns about suicidal thoughts and the SSRI (selective serotonin reuptake inhibitors) class of drugs, told the Guardian that the FDA announcement was close to stating that the drugs caused the problems that have been reported.

"They won't use the 'cause' word all that quickly but they have said this happens during the early days of treatment and it also happens when you change the dose. That is as causal as you can get," he said.

An expert working group was set up by the UK drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), last year to investigate the allegations not only that the drugs made people suicidal and aggressive, but also that they suffered severe side-effects when they tried to stop taking them.

The group looked first at the clinical trial evidence relating to children and found that there were more suicides in those on SSRIs than on the placebo. As a result, the MHRA banned the use of all the drugs except Prozac by those under 18.

But the working group is still examining the evidence in adults.

Richard Brook, chief executive of the mental health charity Mind, resigned a fortnight ago from the group over the MHRA's reluctance to reveal publicly that Seroxat over the minimum dose of 20mg a day was ineffective and led to more side-effects. He now thinks the MHRA should follow the example of the US.

"In view of this decision by the conservative FDA, I think the MHRA must now immediately issue advice to people in the UK over suicidality in adults," he told the Guardian.

Full Guardian article
FDA guidance on SSRIs

See also:
March 21: Chief exec of Medicines and Healthcare Products Regulatory Agency criticises charity director for provoking "alarm" and "confusion" over antidepressant safety - Richard Brook faces rebuffal after accusing Committee of Safety on Medicines group of negligence over its investigations into SSRI antidepressants.
March 15: MIND's chief executive resigns from expert group reviewing safety of antidepressants - Richard Brook accuses regulatory agency of negligence
Feb 8, 2004: GlaxoSmithKline 'held back' data on SSRI anti-depressants for children - latest developments in the SSRI controversy. Plus, advisers to the US Food and Drug Administration warn that SSRIs may increase suicidal thinking among children
June 14, 2003: Seroxat banned for under-18s - the latest from the Guardian
May 10, 2003: GPs accused of not reporting Seroxat suicides - reports the Guardian

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