Selective serotonin reuptake inhibitors (SSRIs) like Paxil are a type of prescription antidepressant medication which function by restoring the balance of serotonin in the brain, a neurotransmitter responsible for controlling mood. By doing so, these drugs may be able to relieve depression and improve other mood disorders. The active ingredient in Paxil is paroxetine, and the drug was approved by the FDA in 1992 for the treatment of major depressive disorder. The FDA added an indication in 1996 for major panic disorder and obsessive-compulsive disorder, in 1999 for social anxiety disorder, in 2000 for post-traumatic stress disorder, and in 2001 for generalized anxiety disorder. Paxil is currently manufactured by pharmaceutical company GlaxoSmithKline, and has become one of the most widely prescribed antidepressant medications on the market.
Regardless of the popularity of Paxil, a significant body of research has surfaced recently which has centered around the potentially harmful nature of SSRI antidepressants like Paxil, especially in treating pregnant women. A number of recent studies have indicated that women who take SSRIs like Paxil during pregnancy may significantly increase their chances of giving birth to infants with one or more serious birth defects, including limb defects.
Limb defects are characterized by the failure of an upper or lower limb, or portion of a limb, to develop properly in utero. There are many different types of limb defects, the classification of which depends upon the manner in which the limb is affected. An infant may suffer from the complete absence of a limb; overgrowth, in which the limb is larger than normal; undergrowth, in which the limb is smaller than normal; duplication, such as extra fingers or toes; failure to separate, such as webbed fingers or toes; or constriction band syndrome, in which a constricting band of tissue forms around the limb and restricts blood flow and tissue growth.
Club foot is one of the most common types of limb defect and affects children whose foot or feet are smaller than normal and internally rotated at the ankles. Without treatment, affected infants may begin to walk on the outside of their feet or ankles, causing large sores or callouses to form. The child may also suffer from an awkward gait and restricted growth of the calf muscle. Although this malformation is relatively painless at birth, club foot can worsen over time and become an extremely debilitating condition later in life.
Because the nature of limb defects can vary widely, depending on the type and severity of the malformation, the proper method of treatment typically differs on a case-by-case basis. Specific treatment is often determined by the child’s age and overall health, the child’s tolerance for certain medications and procedures, and the expectations for the course of the condition. Regardless of the method chosen though, the main goal of limb defect treatment is to restore the appearance and function of the affected limb to the highest extent possible. For instances in which the malformation cannot be repaired, the goal of treatment is to facilitate the child’s adaptation to the defect.
In 2005, the FDA issued a public health advisory warning patients and healthcare providers about the potential connection between fetal exposure to paroxetine (Paxil) and an increased risk of congenital birth defects, namely heart defects. The notice also officially elevated the pregnancy category of Paxil from C to D. This FDA decision was made in response to new information provided by two unpublished epidemiology studies. The first study used data from a Swedish national pregnancy registry in order to evaluate the potentially harmful nature of Paxil in treating pregnant women. According to the report, infants born to women who 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 performed in the United States and determined that women who took Paxil during the first trimester of pregnancy were 1.5 times as likely to to give birth to an infant with a heart defect, and 1.8 times as likely to give birth to an infant with a congenital birth defect in general, compared to infants exposed to other antidepressant drugs in utero.
The FDA issued another public health advisory in 2006, warning patients and physicians about the increased risk of PPHN among infants exposed to SSRIs like Paxil during pregnancy. PPHN, or persistent pulmonary hypertension of the newborn, is a severe heart and lung condition in which a child’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. According to the study, infants whose mothers took an SSRI like Paxil after the twentieth week of pregnancy were an alarming six times more likely to be born with PPHN. In 2007, the New England Journal of Medicine published two additional studies in which researchers sought to examine the adverse effects of SSRI antidepressants on infants exposed to the drugs in utero. The first study indicated that infants born to women who took an SSRI like Paxil during the first trimester of pregnancy were nearly twice as likely to develop birth defects like limb defects, club foot and anal atresia. Researchers also found a connection between the drugs and neural tube birth defects, cleft palate and cleft lip. According to the second study, infants exposed to SSRIs like Paxil in utero were more than twice as likely to be born with devastating birth defects like anencephaly, omphalocele and craniosynostosis.
The FDA has elevated the pregnancy category of Paxil from C to D, which means there is positive human evidence of the drug’s potential to cause significant, unreasonable 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 physicians in order to discuss alternative treatment options. The FDA has advised healthcare providers to avoid prescribing category D medications like Paxil to pregnant women unless the possible benefits of the treatment justify the potential risks to the fetus. You should never suddenly stop taking a prescription medication, as this may cause further harm to you or your child, but with your doctor’s help, you may be able to find a safer way to treat your condition.
SSRI antidepressants like Paxil have the potential to cause significant pain and suffering for an exposed infant and his family. Unfortunately, according to the Journal of the American Medical Association, more than 80,000 pregnant women are prescribed SSRI antidepressants in the United States in any given year. If you or a loved one has suffered from a limb defect, which you believe to be associated with the use of Paxil, contact a Paxil attorney as soon as possible. You may have grounds to file a Paxil lawsuit against GlaxoSmithKline. The goal of Paxil lawsuits and potential Paxil class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from treating the injuries, and the pain and suffering endured by you and your family. Defective drug lawsuits also bring much-needed attention to the importance of safe medications and the need for more stringent regulations on the dangerous drugs already on the market.
Victims of serious injuries resulting from the proper use of a dangerous drug are not at fault. Drug manufacturing companies like GlaxoSmithKline are responsible for the safety of their medications, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies are aware of the potential hazards of their drugs, and intentionally withhold this information in order to avoid negative consequences, such as a drug recall. This deceptive practice exposes millions of consumers to unnecessary harm simply by taking their prescription medications. The only way to protect your rights and collect the compensation you deserve is to hire a qualified Paxil lawyer to represent your case.