On July 19, 2006 the Food and Drug Administration (FDA) released a special Public Health Advisory about SSRIs like Paxil and birth defects. Entitled “Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns,” the advisory was the culmination of several studies into one federal policy – and one that many believed was long overdue. 

The first study mentioned in the FDA Advisory was published in the Journal of the American Medical Association (JAMA) February 1, 2006. This study underlined that pregnant women who stopped taking their medication were five times more likely to have a relapse into depression than those women who continued to take their prescribed medication.

The second study discussed talks about the “additional, though rare, risks” of taking Paxil and other SSRIs during pregnancy. The study, published in the New England Journal of Medicine (NEJM) on February 9, 2006, suggests that the risk of persistent pulmonary hypertension (PPHN) in infants increases by as much as six times for women taking SSRIs during their pregnancies. This serious and potentially fatal condition causes high blood pressure in the infant’s lungs, reducing the amount of oxygen reaching the bloodstream – and in some cases preventing the babies from getting enough to live and thrive.

The FDA points out that “the uncommon potential risk to the newborn of PPHN has not been confirmed by additional studies,” and that it is “seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy.”

What is interesting about the Advisory is not so much what it says, but how it says it. The supposedly-objective agency seems to downplay the risks of taking drugs like Paxil during pregnancy, even in the case of severe birth defects. The simple fact that the FDA mentions a study that found women are more likely to become depressed when not taking an antidepressant can be viewed as a protection of the pharmaceutical industry, not the consumer. Besides, is it really news that taking an antidepressant reduces your risk of depression?

Ultimately, the safety of any product is the responsibility of the manufacturer. If you or a loved one has been injured while taking Paxil or any other medication, contact the medical law experts at Jim S. Adler & Associates. We have the knowledge and experience to fight these sometimes-complex cases in a court of law, and we may be able to get you the compensation you deserve. Call Jim S. Adler & Associates directly or fill in the details of your Paxil birth defect on this page for a free case review.

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