A year ago, the FDA reclassified Paxil from a Category C drug to a Category D for pregnant women. Category C is for drugs that have been shown to harm the fetus in animals. Category D means a drug has been found to harm the human fetus.
In a December 1, 2006, news release, the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice, advised that Paxil should be avoided "by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects."
An interesting comment in the announcement states: "Unpublished data regarding the use of Paxil® during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations."
This discussion begs the question of exactly how much more "unpublished data" is out there about the dangers of Paxil that the public will hear about later, rather than sooner.
On December 8, 2005, the FDA issued a public advisory to report that a Swedish study showed women who received Paxil in early pregnancy had an approximately 2-fold increased risk of having an infant born with a cardiac defect compared to the general population.
The agency also reported that another study, of a US insurance claims database, found that infants born to women who received Paxil in the first trimester of pregnancy were at a 1.5-fold increased risk for cardiac malformations compared to women who received other antidepressants or women in the general population.
Medical experts say Paxil exposure is especially harmful in the first trimester because fetal heart development occurs early in pregnancy. According to Dr Lara Jana, MD, FAAP, in Early Fetal Heart Development: 0-9 Weeks, published on the Dr Spock Web site, the most critical period in development is between three and seven weeks after fertilization, when a heart tube assumes the shape of a 4-chambered heart.
It is always important to point out that because GlaxoSmithKline (GSK) promotes Paxil to treat a wide variety of "disorders," many pregnant women may be taking the drug, who are totally unaware of the risks because they have never been diagnosed with depression.
According to GSK, Paxil is indicated for the treatment of obsessive-compulsive disorder, major depressive disorder (MDD), panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder; and Paxil CR is indicated for the treatment of panic disorder, social anxiety disorder, and premenstrual dysphoric disorder. Doctors are also too eager to prescribe Paxil off-label for everything from migraines to nail biting.
An important point to consider when weighing the risks and benefits of prescribing Paxil to pregnant women, is that most experts who have evaluated the study data on SSRIs, say the drugs do not work.
One of latest reviews in the July 2005, British Medical Journal, by Moncrieff & Kirsch, states in part: (1) Recent meta-analyses show [SSRIs] have no clinically meaningful advantage over placebo; (2) Methodological artefacts may account for the small degree of superiority over placebo; and (3) Given doubt about their benefits and concern about their risks, current recommendations for prescribing antidepressants should be reconsidered.
Infant SSRI Withdrawal Syndrome
The fact that SSRIs can be extremely difficult to quit due to debilitating withdrawal reactions also adds to the dilemma that women face if they become pregnant. "A lot of these medicines are associated with withdrawal syndromes, which can be very problematic for many patients, so stopping is something that needs to be monitored carefully by your doctor," Sandra Kweder, MD, deputy director of the FDA's Office of New Drugs, states in a March/April 2006 update about the risks of Paxil use by pregnant women on the FDA's Web site.
But on the other hand, staying on the SSRI places infants at risk. A February 2006, study in the Archives of Pediatrics & Adolescent Medicine reported that nearly one-third of babies born to mothers taking SSRIs showed severe symptoms of withdrawal, including high-pitched crying, tremors, gastrointestinal problems and disturbed sleep patterns.
Other Birth Defects
Over the past several years, in addition to heart defects, a variety of birth defects have been found to be associated with Paxil and the other SSRIs. A 2005 study in Teratology Society Abstracts, found that women who took Paxil were more likely to have an infant with omphalocele, a malformation where the abdominal contents protrude into the base of the umbilical cord, and craniosynostosis, an early closing of one or more of the sutures of an infant's head, causing a malformation of the skull.
