Washington — According to the Food and Drug Administration Dept. of U.S., all 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 FDA has 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 mentioned the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy. However, FDA is seeking more information about persistent pulmonary hypertension in newborns from the drugs.
But, the agency has 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.
FDA has also advised patients to talk to their doctors about deciding whether to continue taking the drugs.
These concerns are being thought to be the result of a February study in The New England Journal of Medicine that found those taking SSRIs were six times more likely to have a baby suffering from the condition in which high blood pressure in the lungs makes it hard to breathe.
FDA has advised women who are pregnant or thinking about becoming pregnant to talk to their doctors about deciding whether to continue taking an antidepressant.
“The decision to continue medication or not should be made only after there has been careful consideration of the potential benefits and risks of the medication for each individual pregnant patient,” the FDA said.
Patients also should be closely monitored to see if their depression returns, said FDA.