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 Food and Drug Administration said 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.
SSRIs, or selective serotonin reuptake inhibitors, include GlaxoSmithKline Plc's Paxil, Eli Lilly and Co's Prozac, Pfizer Inc's Zoloft and Symbyax, Forest Laboratories Inc's Celexa and Lexapro, and Solvay Pharmaceutical's Luvox, which is also sold generically as fluvoxamine.
The SNRIs, or selective serotonin/norepinephrine reuptake inhibitors, cited by the FDA are Lilly's drug Cymbalta and Wyeth's Effexor.
Triptan migraine drugs include Glaxo's Imitrex and Amerge, Johnson & Johnson's Axert, Endo Pharmaceutical's Frova, Merck and Co Inc's Maxalt, Pfizer's Relpax and AstraZeneca Plc's Zomig.
The agency advised patients to talk to their doctors about deciding whether to continue taking the drugs.
