Paxil (generic paroxetine) belongs to the selective serotonin reuptake inhibitors (SSRIs) class of antidepressants, and is prescribed to treat depression and anxiety disorders. Paxil is also marketed as Sereupin, Seroxat, Aropax, Deparoc, Deroxat, Divarius, Rexetin, Loxamine, Xetanor, and Paroxat. It was approved in 1993 and has become one of the most popular antidepressant drugs; about 25 percent of those taking Paxil are women of childbearing age.
Several research studies have shown that taking Paxil during the first trimester can increase the risk of having a baby with birth defects. In light of these studies, the Food and Drug Administration (FDA) has reclassified Paxil as a pregnancy category D drug, meaning that studies have shown positive evidence of risk to the fetus. The FDA warned that Paxil "should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future."
In December 2005, the FDA issued a warning that using Paxil during the first trimester may double the risk of fetal heart defects such as atrial and ventricular septal defects. According to studies cited by the FDA, the overall risk of heart defects is about 1 percent, compared to 1.5 to 2 percent in infants who were exposed to Paxil in the womb. Also, according to a study published in the New England Journal of Medicine, taking SSRIs like Paxil, Zoloft, and Effexor after the 20th week of pregnancy may increase the risk of having a baby with Persistent Pulmonary Hypertension of the Newborn (PPHN). PPHN is a rare but serious lung condition which prevents the baby from getting enough oxygen. Treating PPHN requires serious medical intervention, and unfortunately about 10-20% of babies with this condition do not survive.
Paxil is also linked to an increased risk of other birth defects such as craniosynostosis (skull defect), omphalocele (abdominal wall defect), anencephaly (open cranium without a brain), hydrocephalus (abnormal buildup of fluid in the brain), spina bifida, and club foot. In July 2011, CNN reported on a new study showing that exposure to Paxil and other SSRI antidepressants in the first trimester may lead to four times the risk of autism spectrum disorder.
General Information on Birth Defects
Certain over-the-counter and prescription medications contain teratogenic (birth defect-causing) substances. Teratogenic drugs can cause harm to the fetus in three ways. Some damage the fetus directly, while others compromise the ability of the placenta to function (resulting in low birth weight). Lastly, some drugs harm the fetus by triggering contractions or premature labor.
Teratogenic drugs affect the fetus most during the first trimester of pregnancy. However, some medications can harm the fetus during the entire nine months of pregnancy. Drugs that are taken before conception (20 days or more) may either have no effect, or induce miscarriage.
The FDA uses pregnancy categories to indicate the possible risk to a fetus when taken during pregnancy:
- Category A - Sufficient, well-controlled studies indicate no evidence of risk to a fetus.
- Category B - Studies on animals indicate no evidence of risk to a fetus; sufficient and well-controlled studies on humans do not yet exist.
- Category C - Studies on animals show possible risk to a fetus, but the benefits of the drug may outweigh the potential risk. Sufficient, well-controlled human studies do not yet exist.
- Category D - Studies on pregnant women show evidence of risk to the fetus. However, in some cases the health benefits of using this drug may outweigh the possible risk.
- Category X - Positive evidence of risk to the fetus. Women who are or planning to become pregnant should not use this drug.
- Category N - The FDA has not yet classified this drug.
If you have used Paxil during pregnancy and believe it may have caused your child's birth defects, you could be entitled to compensation. The experienced birth defect attorneys [link to About the Firm page] at Oshman & Mirisola, LLP have provided quality, compassionate legal representation for over 35 years. Call us at (800) 400-8182 or submit our online Contact Us form for a free initial consultation.