FDA to Issue Public Health Advisory on Antidepressants During Pregnancy
According to Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs, the agency will issue a public health advisory within days in response to an article in the New England Journal of Medicine that links use of drugs like Paxil, Prozac, and Zoloft late in pregnancy with a condition that can endanger infants’ lives.
A Boston Globe report carried by the APA’s PsycPort quotes Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs, commenting on a paper in the New England Journal of Medicine that links use of drugs like Paxil, Prozac, and Zoloft late in pregnancy with a condition that can endanger infants’ lives.
Summarizing the New England Journal of Medicine article:
- Persistent pulmonary hypertension of the newborn (PPHN) is associated with substantial infant mortality and morbidity. A previous cohort study suggested a possible association between maternal use of the selective serotonin-reuptake inhibitor (SSRI) fluoxetine late in the third trimester of pregnancy and the risk of PPHN in the infant.
- Fourteen infants with PPHN had been exposed to an SSRI after the completion of the 20th week of gestation, as compared with six control infants (adjusted odds ratio, 6.1; 95 percent confidence interval, 2.2 to 16.8). In contrast, neither the use of SSRIs before the 20th week of gestation nor the use of non-SSRI antidepressant drugs at any time during pregnancy was associated with an increased risk of PPHN.
According to the Boston Globe article, regulatory options include updating drug labels, searching public and private databases to corroborate the drug link to the lung condition, and requiring additional trials from drug manufacturers.
The article goes on:
But because the condition — persistent pulmonary hypertension of the newborn — is rare and failure to treat maternal depression can cause its own problems, the study’s lead author does not expect the FDA to follow the lead of Canadian regulators, who warned against using new-generation antidepressants during pregnancy.
In October 2004, the FDA told manufacturers to add warnings on boxes alerting patients that the antidepressants increase suicidal thoughts and behaviors in children taking them. Last December it warned of an association between Paxil and heart defects when the drug is taken early in pregnancies.
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This article was last reviewed by on Thursday, 9th February 2006. You can leave a response below.
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12th February 2006
My wife’s daughter just lost her baby due to her taking prozac late in her pregnncy. Everybody is angry,sad, and hurt. We just heard about the news on antidepressants and pregnancy. It’s not right.
13th February 2006
Hi Jason,
I’m very sorry to hear of your family’s loss. I wouldn’t expect you to say very much (if anything) here, but am I right in inferring from the context that your wife’s daughter’s baby died of the condition the article refers to as persistent pulmonary hypertension of the newborn (PPHN)?
The New England Journal of Medicine article represents the very latest findings in this area, which by the sounds of it may well lead to revised labelling for the drugs, helping to ensure that doctors and patients alike will know of the risks in the future. Unfortunately, the fact that no one previously knew about this problem does not make the magnitude of loss any less for those of you who have been directly affected by it.
Again, my condolences,
Greg