New Warnings about Paxil:
Studies in pregnant women, taking Paxil have shown a risk to the fetus. Two studies of pregnant women taking Paxil during their first trimester showed that their babies have heart defects at a rate of 1.5 to 2 times the norm. The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.
Birth Defects
The FDA is strengthening its warning for the antidepressant Paxil because it may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects. The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name Paroxetine, as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus.
What is Paxil (Paroxetine hci) used for?
Paxil is prescribed for the treatment of depression. Manufactured by SmithKline Beecham (dba GlaxoSmithKline), Paxil entered the market in the United States in December of 1992. It was the third of the selective serotonin reuptake inhibitors (SSRIs) to hit the U.S. market for the treatment of depression.
American College of Obstetricians and Gynecologists Opinion
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).
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