Wednesday, July 19, 2006

FDA toughen up antidepressant labels

Information about risks to newborns and migraine sufferers linked to some of the world's most widely used antidepressants should be added to the drug labels, the U.S. Food and Drug Administration said on Wednesday.

The FDA warned that taking antidepressants known as SSRIs -- including Prozac and Zoloft -- or certain SNRIs in combination with migraine drugs known as triptans could result in a life-threatening condition called serotonin syndrome.

It also warned consumers about the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy. The agency added it was seeking more information about persistent pulmonary hypertension in newborns from the drugs.

The agency asked drug makers to list the potential risks on their drug labels.

Source: Reuters

Insider wonders how the newborn PH issue will sit with the "CME psychs" advising SSRI use throughout pregnancy?

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