FDA Alerts

FDA Letter to Doctors and Patients

As a result of the increasing concerns about Paxil, the U.S. Food and Drug Administration issued an FDA alert to health care professionals and patients in September 2005. This letter advised doctors and patients that a study demonstrated taking Paxil during the first three(3) months of pregnancy increases the risk of birth defects, and in particular heart defects. In fact, women who took Paxil were twice as likely to give birth to a baby with a heart defect, than other women.

Paxil has also been associated with a condition called Persistent Pulmonary Hypertension of the Newborn (PPHN).

Because of recent studies and new information, Paxil's "pregnancy use classification" has been changed from category C to category D. In December 2005, the FDA required a label revision to warn of the possible adverse effects of Paxil use during pregnancy. Pregnancy Category D means there is positive evidence of human fetal risk based on adverse reaction data from investigation or marketing experience or studies in humans.

Protecting Your Child's Health

Knowledge is the first step to protecting the health of your child, as well as your rights.  As pharmaceutical litigation lawyers serving clients nationwide, Blizzard, McCarthy & Nabers seek to win justice and compensation for you.

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