Paxil belongs to a class of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors. These drugs work by increasing or restoring the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Paxil was approved by the FDA in 1992 to treat individuals with major depressive disorder, and was further indicated in 1996 for the treatment of obsessive-compulsive disorder and major panic disorder, in 1999 for social anxiety disorder, in 2000 for post-traumatic stress disorder, and in 2001 for generalized anxiety disorder. The active ingredient in Paxil is paroxetine and the drug is currently manufactured by pharmaceutical company, GlaxoSmithKline.
Despite the fact that Paxil and other SSRI antidepressants have become some of the most commonly prescribed medications on the U.S. market, an emerging body of research has identified these drugs as potentially dangerous in treating pregnant women. In fact, according to a number of credible studies, women who take SSRI antidepressants like Paxil while pregnant may significantly increase their risk of giving birth to infants with one or more major birth defects, including anal atresia.
Anal atresia, also called imperforate anus, is a congenital birth defect in which the opening to the anus is missing or blocked, preventing stool from leaving the body properly. In some instances, the rectum may end in a blind pouch that fails to connect to the colon, or it may have openings to the urethra, bladder, vagina in girls, or base of the penis in boys. Common symptoms of anal atresia include:
The only proper method of treatment for anal atresia is for the child to undergo reconstructive surgery in order to repair the defect. If the rectum connects to other organs, these organs may need to be repaired as well. Unfortunately, even with prompt diagnosis and treatment, some children may suffer from complications like bowel incontinence, intestinal blockage and constipation. Some infants born with anal atresia are affected by additional malformations, especially those involving the genitals, urinary tract and spine, so all children with this defect should be tested for other birth injuries.
The FDA issued a public health advisory in 2005 warning patients and healthcare providers about the increased risk of congenital birth defects, namely heart defects, among infants exposed to paroxetine (Paxil) during pregnancy. The advisory also effectively elevated the pregnancy category of Paxil from C to D. This FDA warning was issued based on information provided by two unpublished epidemiology studies which indicated that paroxetine exposure during fetal development may have harmful effects on the exposed fetus. According to the first study, which gathered data from a Swedish national pregnancy registry, infants whose mothers took Paxil during early pregnancy were nearly twice as likely to develop a heart defect, compared to the entire registry population. The second study was conducted in the United States and determined that infants exposed to Paxil during the first trimester of pregnancy had a 1.5-fold increased risk of heart defects, and a 1.8-fold increased risk of congenital birth defects overall, compared to infants exposed to other antidepressant drugs in utero.
The FDA issued another public health advisory in 2006, shortly after the New England Journal of Medicine published a revealing SSRI antidepressant birth defect study. According to the study, women who took an SSRI antidepressant like Paxil after the twentieth week of pregnancy were an alarming six times more likely to give birth to an infant with PPHN, compared to women who didn’t take an SSRI while pregnant. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening birth defect in which a child’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. The NEJM published two additional studies in 2007, the first of which indicated that infants whose mothers took an SSRI like Paxil during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like anal atresia, club foot and limb defects. Researchers also found a connection between these drugs and cleft palate, neural tube birth defects and cleft lip. According to the second study, infants exposed to SSRIs like Paxil during pregnancy were more than twice as likely to develop catastrophic birth defects like craniosynostosis, anencephaly and omphalocele.
The FDA has elevated the pregnancy category of Paxil from C to D, a category reserved for drugs which positive human evidence shows may cause serious harm to a fetus when taken during pregnancy. If you are currently taking Paxil and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It may be dangerous to discontinue use of a prescription medication without medical consent, as this may cause further damage to you or your child. However, with your doctor’s help, you may be able to find a safer alternative to Paxil for treating your medical condition.
Although birth defects like anal atresia can typically be repaired with surgery, seeking proper medical care is likely to result in costly medical expenses for the child’s family. Unfortunately, this can lead to a severe financial burden for a family already emotionally distressed by a birth defect diagnosis. Furthermore, anal atresia is often accompanied by additional birth defects which may cause more severe complications for an affected child. If you or a loved one has suffered from anal atresia, and you believe Paxil to be the cause, contact a Paxil attorney immediately. You may have grounds to file a Paxil lawsuit against GlaxoSmithKline in order to seek financial compensation for your injuries, medical expenses, and pain and suffering. Defective drug lawsuits also bring public attention to the need for safer medications on the market.
Victims of serious injuries associated with the use of a dangerous drug are not at fault. Drug manufacturing companies like GlaxoSmithKline are responsible for the safety of their medications, even after they enter the market, and they should be held liable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally conceal dangerous drug information in order to ensure FDA approval and avoid negative consequences like a drug recall. Consumers have a right to accurate information concerning the benefits and risks involved in taking their prescription medications. Regrettably, the deceptive practices of some drug companies blindly rob consumers of this right. Only by hiring a qualified Paxil lawyer to represent their case can victims of alleged Paxil birth defects protect their rights and collect the compensation they deserve.