Paxil (paroxetine) belongs to a class of prescription antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs), which function by balancing the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Paxil garnered FDA approval in 1992 for the treatment of major depressive disorder, and was additionally approved in 1996 to treat obsessive-compulsive disorder and major panic disorder, in 1999 for social anxiety disorder, in 2000 for post-traumatic stress disorder, and in 2001 for the treatment of generalized anxiety disorder. In some cases Paxil may be prescribed to children, although the drug has only been FDA approved for treatment in adults. Paxil (paroxetine) is currently manufactured by pharmaceutical company GlaxoSmithKline and can be found in 10mg, 20mg, 30mg and 40mg tablets, and a liquid solution containing 10mg of paroxetine per 5mL of liquid.
In spite of the popularity of antidepressant drugs, Paxil and other SSRIs may be linked to an increased risk of birth defects among infants whose mothers took the drugs during pregnancy. According to a number of SSRI birth defect studies, fetal exposure to antidepressants like Paxil may significantly increase a child’s risk of being born with one or more major malformations, including:
The FDA issued a public health advisory in 2005 warning patients and healthcare providers about the potential connection between fetal exposure to paroxetine (Paxil) and an increased risk of congenital birth defects, particularly heart defects. This FDA decision was directly influenced by two unpublished epidemiology studies, and led to the FDA’s decision to raise Paxil’s pregnancy category from C to D. According to the first study, which used data from a Swedish national registry, women who took Paxil in early pregnancy had a nearly two-fold increased risk for giving birth to an infant with a heart defect, compared to the entire national registry population. The second study was conducted in the United States and indicated that infants whose mothers took Paxil during the first trimester of pregnancy had a 1.5-fold increased risk for heart defects and a 1.8-fold increased risk for congenital birth defects overall, compared to infants whose mothers took other antidepressants during pregnancy.
Another public health advisory was issued by the FDA in 2006 after new information was released concerning the potential connection between SSRI drugs like Paxil and PPHN, or persistent pulmonary hypertension of the newborn. This warning was based upon the alarming results of a study published in the New England Journal of Medicine in 2006, in which researchers found a six-times increased risk of PPHN among infants exposed to SSRI antidepressants like Paxil during the third trimester of pregnancy. 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.
A number of other SSRI antidepressant birth defect studies have been conducted in recent years by credible medical journals. In 2007, the NEJM published two additional studies, the first of which indicated that infants exposed to SSRI antidepressants 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 neural tube birth defects, cleft palate and cleft lip. In the second study, researchers determined that infants born to women who took an SSRI antidepressant like Paxil while pregnant were more than twice as likely to suffer from devastating birth defects like anencephaly, craniosynostosis and omphalocele. Another study published in 2010 in the American Journal of Nursing indicated that infants exposed to SSRIs like Paxil in utero were nearly twice as likely to be born with serious heart defects, particularly atrial and ventricular septal defects.
The FDA has elevated the pregnancy category of Paxil from C to D. Category D is reserved for medications which positive human evidence has shown may cause significant, unreasonable harm to a fetus when taken during pregnancy. Because of this information, the FDA has advised physicians to avoid prescribing Paxil to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus. If you are currently taking Paxil and you are pregnant or planning to become pregnant, consult your physician immediately. You should never stop taking a prescription medication without medical consent, as this may cause further harm to your or your child. However, with your doctor’s help, you may be able to find a safer alternative to Paxil for treating your condition.
The birth defects allegedly associated with the use of Paxil have the potential to cause serious and even life-threatening complications for a newborn child. Unfortunately, for those children whose birth defects are treatable, proper medical care is likely to result in exorbitant medical expenses, which can be an overwhelming burden for an already emotionally distressed family. If you or a loved one has suffered from a birth defect which you believe to be associated with the use of Paxil, contact a Paxil attorney immediately to discuss your legal options. You may be entitled to reimbursement for your injuries and medical expenses, which you can collect by filing a Paxil lawsuit against GlaxoSmithKline.
Consumers expect their prescription medications to effectively treat their condition or disorder without causing them unreasonable harm. Even the FDA measures the value of drugs before they are permitted to enter the market by determining whether or not the possible benefits of the drug outweigh the potential risks to the fetus. However, there are drugs currently on the market which may have the potential to cause consumers more harm than good. It is the responsibility of pharmaceutical companies to provide the public with accurate drug information so that consumers can make educated decisions regarding their use of prescription medications. Unfortunately, some drug companies intentionally conceal the potential hazards of their products in order to avoid negative consequences like a drug recall. This deceptive practice puts millions of consumers at risk of suffering serious injury, illness and even death without their knowledge. The only way to protect your rights and stand up to big drug companies is to hire a qualified Paxil lawyer to represent your case.