Pregnant Women, Those Planning Pregnancy Should Avoid Taking Antidepressant Paxil, ACOG Opinion Says

Pregnant women or those who are planning for pregnancy should avoid taking GlaxoSmithKline's antidepressant Paxil because it can increase the risk of birth defects, according to an opinion published by an American College of Obstetricians and Gynecologists committee in the December issue of ACOG's journal Obstetrics & Gynecology, the AP/Seattle Post-Intelligencer reports (AP/Seattle Post-Intelligencer, 11/30). ACOG's Committee on Obstetric Practice's opinion recommends that women who were exposed to Paxil in early pregnancy should consider having a fetal echocardiography, which detects heart trouble HealthDay News/Forbes reports (HealthDay News/Forbes, 11/29). FDA in December 2005 issued a public health advisory warning pregnant women and physicians about an increased risk of fetal heart defects from taking Paxil -- known generically as paroxetine -- during the first three months of pregnancy. The warning moved Paxil to Category D, FDA's second-highest category for risk of birth defects. According to FDA, Category D means that either "controlled or observational" studies of pregnant women "have demonstrated a risk to the fetus." The advisory was based on previous studies that questioned the safety of using Paxil during pregnancy. One study found an increased risk of an infant experiencing a potentially fatal lung disorder if the woman takes a group of antidepressants called selective serotonin reuptake inhibitors during pregnancy, and two other studies found that use of Paxil during pregnancy could cause cardiac fetal heart defects. Before the advisory, Paxil had been classified as a Category C drug for pregnant women, which means comprehensive studies of its effects during pregnancy have not been performed (Kaiser Daily Women's Health Policy Report, 12/9/05).

ACOG Committee Opinion
ACOG's Committee on Obstetric Practice's opinion also recommends physicians make decisions on treating pregnant women with other SSRIs -- such as Pfizer's Zoloft, Eli Lilly's Prozac and Forest Pharmaceuticals' Lexapro -- on an individual basis (AP/Seattle Post-Intelligencer, 11/30). The opinion says the committee "recommends that treatment with all SSRIs or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine use among pregnant women or women planning to become pregnant be avoided, if possible." ACOG also acknowledged another study that found pregnant women who stopped taking their antidepressant regimen were five times more likely to relapse into depression than women who continued their medication, HealthDay News/Forbes reports. "Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications," the opinion says. ACOG estimates that about one in 10 women of reproductive age will experience a period of major or minor depression sometime during or after pregnancy or the postpartum period (HealthDay News/Forbes, 11/29).

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