Prozac Warnings and Alerts

Prozac and other SSRI antidepressants such as Celexa, Lexapro and Zoloft, have been at the center of heated debate due to growing concerns over potential adverse reactions caused by the medication, including serious birth defects. Scientific studies have shown that taking certain antidepressants similar to Prozac during pregnancy can pose serious risks to unborn babies. The Food and Drug Administration has used compelling evidence to warn of certain risks associated with the use of SSRI antidepressants like Prozac during pregnancy.

Category C

The FDA uses a pregnancy category system to classify the potential risk to unborn children when medications are taken during pregnancy. The FDA initially declared Prozac, along with all SSRI antidepressants, a pregnancy “category C” drug, which means that there are no adequate well-controlled studies of the drug on humans, but animal reproduction studies have shown adverse effects on the fetus. The Pregnancy Categories measure the teratogenic effects a drug has on a fetus. Teratogenic means that a drug or other substance is capable of interfering with the development of a fetus.

Congenital heart defects

In 2005, the FDA warned that the use of certain SSRI antidepressants during pregnancy could potentially increase the risk of congenital heart defects in infants. According to an FDA Public Health Advisory, several studies indicated that exposure to SSRI antidepressants similar to Prozac increased the risk of cardiac birth defects. The studies focused on atrial and ventricular septal defects, potentially life threatening conditions in which the wall between the right and left sides of the heart is abnormal.

PPHN

The FDA issued a Public Health Advisory in 2006 for Prozac and several other antidepressants based on a study published in the New England Journal of Medicine (NEJM). The study found that infants born to mothers who took Prozac during their pregnancy were six times more likely to be born with Persistent Pulmonary Hypertension of the Newborn (PPHN). PPHN is a life threatening congenital disorder occurring when the blood vessels in an infant's lungs constrict, causing pressure to increase in the pulmonary artery, thus not allowing oxygen-rich blood to flow through the body.

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