Women Not Warned About SSRI-Related Lung Birth Defect

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Dr Steinhorn also notes that an increased frequency of social problems, academic difficulties at school age and higher rates of attention deficit disorder are reported in children who received ECMO.

Although the actual FDA warning about PPHN was not added to the antidepressant labels until August 2006, the drug makers were well aware of the risk of this birth defect for more than a decade, due to a long and steady line of studies that linked the drugs to serious respiratory problems in newborns dating back to 1996.

A study in the October 3, 1996, New England Journal of Medicine, lead by Dr Christina Chambers of the Department of Pediatrics at the University of California-San Diego, reported that PPHN developed in 2.7% of a group of infants whose mothers took Prozac throughout their pregnancy.

From 1989 through 1995, the California Teratogen Information Service and Clinical Research Program received approximately 1,500 calls requesting information on the potential teratogenic effects of Prozac (fluoxetine), and an estimated one-third of the calls were made by pregnant women who were currently taking Prozac.

For their study, the researchers selected 228 of these women. Because they hypothesized that birth size, gestational age, and neonatal adaptation were influenced by exposure to Prozac late in pregnancy, the women were divided into two groups.

One group was referred to as the exposed-early group because the women discontinued Prozac in the first or second trimester, and another group was referred to as the exposed-late group because the women continued to take Prozac in the third trimester.

A third group of 254 pregnant women who called the same California Information Program between 1989 through 1995, but with questions about other drugs and procedures that were not considered teratogenic, was enrolled as a control group.

The researchers determined that 73 infants in the exposed-late group had higher rates of premature delivery, admissions to special care nurseries, and poor neonatal adaptation, including respiratory difficulty, cyanosis on feeding and jitteriness. Birth weight was also lower and birth length shorter in the exposed-late infants, they found.

The study authors noted their concern over the 15.5% incidence of three or more minor anomalies in some infants exposed to Prozac in early pregnancy. "The combination of any three minor anomalies in a single child is an unusual finding," they wrote.

The 15.5 percent incidence, they said, indicates that exposure during the first trimester has an effect on embryonic development. "This finding raises the possibility of an associated defect in the development of the central nervous system that may become evident when the infant is older," the authors wrote.

In January 1998, a study in the international journal of medical science and practice, The Lancet, explained that the lungs act as a reservoir for antidepressants and this study suggests that SSRI's could play a pivotal role in infant respiratory conditions, such as PPHN. Another study, in the April 2002 Journal of Laboratory and Clinical Medicine, investigated the effects of SSRI's on pulmonary circulation and found that SSRI's affect the pulmonary smooth muscle cells and aggravate pulmonary hypertension.

In June 2004, a study in Prescrire International also reported that newborns exposed to SSRI's toward the end of pregnancy showed signs of altered muscle tone, breathing and suction problems, and agitation, with an estimated 20% to 30% of the infants affected.

The next month, after receiving hundreds of adverse event reports over a decade, in July 2004, the FDA finally revised the labels for all SSRI's and SNRI's, warning that some newborns exposed to the drugs had developed problems requiring prolonged hospitalizations, respiratory support and tube feeding.

Less than a year later, a study in the May 2005 Journal of the American Medical Association reported that women who took SSRI's or SNRI's late in pregnancy were at a 3 times higher risk of giving birth to infants suffering from serious respiratory problems, jitteriness and irritability. Lead author, Dr Eydie Moses-Kolko, reported that serious respiratory problems developed in about one out of every 100 infants.

According to Dr David Healy, a leading expert on pharmacology and author of "The Antidepressant Era," the doctors who prescribe SSRI's are often not able to spend enough time with patients to discuss their emotional issues in depth. "For some doctors," he notes, "SSRI's may appear to provide a quick solution for patient problems arising from normal life events such as bereavement, work stress, or marital conflict."

However, he says, a review of the actual SSRI studies shows that only one patient in 10 responds to these drugs, and he attributes the massive prescribing to successful marketing rather than benefits.

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