F.D.A. Takes Action on Antidepressants and Migraine Drugs - New York Times: "F.D.A. Takes Action on Antidepressants and Migraine Drugs
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By THE ASSOCIATED PRESS
Published: July 20, 2006
WASHINGTON, July 19 (AP) � The Food and Drug Administration asked Wednesday that manufacturers of Prozac and similar antidepressants change their labels to include information about an uncommon but life-threatening lung problem that can affect babies born to mothers who take the drugs during pregnancy.
The agency also issued an alert about the possible risk of combining antidepressant medications with common migraine drugs called triptans, saying a life-threatening condition called serotonin syndrome might occur when the drugs are combined.
The agency said it was seeking more information on both risks.
Babies with the lung disorder, called persistent pulmonary hypertension, have high pressure in the blood vessels of their lungs and are not able to get enough oxygen into their bloodstreams. One or two babies per 1,000 develop the disorder shortly after birth. But a study published Feb. 9 in The New England Journal of Medicine found that infants whose mothers took antidepressants in the second half of pregnancy had six times the expected risk of it.
That report was issued just days after The Journal of the American Medical Association published a study illustrating the potential risk of depression relapse in women who stopped taking prescribed antidepressants during pregnancy. Taken together, the two studies worried many women because they implied that there were risks during pregnancy in both continuing on the medications and not.
The drugs, also called selective serotonin reuptake inhibitors, or S.S.R.I.�s, include Prozac, Zoloft, Paxil and Lexapro. The F.D.A. said Wedn"
E-MailPrint Reprints Save
By THE ASSOCIATED PRESS
Published: July 20, 2006
WASHINGTON, July 19 (AP) � The Food and Drug Administration asked Wednesday that manufacturers of Prozac and similar antidepressants change their labels to include information about an uncommon but life-threatening lung problem that can affect babies born to mothers who take the drugs during pregnancy.
The agency also issued an alert about the possible risk of combining antidepressant medications with common migraine drugs called triptans, saying a life-threatening condition called serotonin syndrome might occur when the drugs are combined.
The agency said it was seeking more information on both risks.
Babies with the lung disorder, called persistent pulmonary hypertension, have high pressure in the blood vessels of their lungs and are not able to get enough oxygen into their bloodstreams. One or two babies per 1,000 develop the disorder shortly after birth. But a study published Feb. 9 in The New England Journal of Medicine found that infants whose mothers took antidepressants in the second half of pregnancy had six times the expected risk of it.
That report was issued just days after The Journal of the American Medical Association published a study illustrating the potential risk of depression relapse in women who stopped taking prescribed antidepressants during pregnancy. Taken together, the two studies worried many women because they implied that there were risks during pregnancy in both continuing on the medications and not.
The drugs, also called selective serotonin reuptake inhibitors, or S.S.R.I.�s, include Prozac, Zoloft, Paxil and Lexapro. The F.D.A. said Wedn"
posted by Chris Placitella | 11:55 AM
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