Women who take the widely prescribed anti-depressant Prozac in the final months of pregnancy may be doing harm to their babies, according to a new study.
California researchers followed hundreds of women taking the medicine, generically known as fluoxetine, during all stages of pregnancy and found that the risk of prematurity, admission to a special-care nursery and poor outcome were more common in babies exposed to the drug in the last trimester.
But researchers from several laboratories caution that the study, to be published today in the New England Journal of Medicine, lacks the proper controls, and that the effects could be due to the mother’s depression and not to the medication.
“I do not think that fluoxetine or tricyclic anti-depressant drugs have been clearly proved unsafe for pregnant women,” Dr. Elisabeth Robert, a researcher at the Institut Europeen des Genomutations in France, wrote in an accompanying editorial. “It seems unjustified to use these new results as a reason to withhold fluoxetine from women who require an anti-depressant drug during pregnancy.”
Christina Chambers and her colleagues at the California Teratogen Information Service and Clinical Research Program at the University of California, San Diego, studied 228 pregnant women taking fluoxetine, and compared the birth outcomes with another 254 women not taking the anti-depressant. Thirty percent of the women on Prozac were also taking another mind-altering medication.
According to the study, babies whose mothers took Prozac during the first trimester had no greater percentage of miscarriage, stillbirth or major birth defects than those unexposed to Prozac.
Among those mothers who continued to take Prozac, a drug that alters the brain chemical serotonin, well into the last trimester, there was a higher incidence of premature delivery and their babies were twice as likely to be placed in special-care nurseries. These babies were more jittery, suffered more respiratory problems and even the full-term babies were smaller than the comparison groups.
“Depressed women need to know what the risks might be so that they can discuss them with their doctors and be ready to deal with complications should they occur,” Chambers said in an interview.