September 21, 2004

All antidepressant drugs must carry the public warning that they could cause children to harm themselves or commit suicide, US authorities said last week.

Societyguardian.co.uk reported that advisers to the Food and Drug Administration at a public hearing agreed that antidepressants can cause some young people to become suicidal.

They opted to require "black box warnings" on the risks to children from all antidepressant drugs.

The outcome of the FDA advisory committee hearings has ramifications for the older antidepressants and those yet to come on the market.

All will be required to show black box warnings that children could become suicidal.

The warnings go beyond the unilateral action taken by the UK regulator, the Medicines and Healthcare Products Regulatory Authority, last year.

It banned the use of certain drugs in children under 18 years old. Prozac was the exception.

But Prozac was not exempted by the FDA advisory committee.

The UK authorities did not extend their ban to Prozac because it was said to be more effective than the rest of the class, which showed little improvement in the condition of depressed children when compared with the placebo.

The FDA is not bound to follow the advice of its advisory committee.

See societyguardian.co.uk article in full

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