Paxil - Cleft Lip - Consumer Justice Foundation

Paxil – Cleft Lip

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Paxil and Cleft Lip Birth Defects

Paxil belongs to a group of prescription antidepressant drugs called SSRIs, or selective serotonin reuptake inhibitors. These drugs function by balancing the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Paxil was approved by the FDA in 1992 for the treatment of major depressive disorder, 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. The active ingredient in Paxil is paroxetine, and the drug is currently manufactured by GlaxoSmithKline. Despite the popularity of Paxil and other SSRI antidepressants however, a number of recent studies have indicated a potential danger associated with these drugs, especially in treating pregnant women. According to this research, infants born to women who take Paxil during pregnancy may have a significantly increased risk of suffering from one or more serious birth defects, including cleft lip.

Cleft Lip Birth Defects Described

Cleft lip is a congenital birth defect which affects the formation of a child’s upper lip during fetal development. Under normal circumstances, a child’s lip is fully developed between the fifth and sixth week of gestation. However, if there isn’t enough tissue in the lip area when the structure is forming, a cleft lip may occur. This malformation is characterized by a vertical fissure in one or both sides of the upper lip, which can vary from a small notch in the lip to a significant opening which may extend up through the nose.

Cleft Lip Treatment and Complications

Because of the opening between the mouth and nose, many infants suffering from a cleft lip struggle with feeding difficulties in which food and liquid pass from the mouth back through the nose. Children born with this defect are also more prone to having fluid build up in their ears, which may lead to chronic ear infections and even hearing loss. Affected infants may also experience dental problems like missing or malformed teeth, and speech and language delay. Although there are temporary treatment options for children with cleft lip, the only way to permanently correct the defect and alleviate these complications is for the child to undergo reconstructive surgery.

FDA Warnings and Alleged Paxil Birth Defects

The FDA issued a public health advisory in 2005 warning patients and healthcare providers about the increased risk of congenital birth defects, particularly heart defects, among infants exposed to paroxetine (Paxil) during pregnancy. The notice also officially elevated the pregnancy category of Paxil from C to D. The FDA’s decision was directly influenced by information provided by two unpublished epidemiology studies. The first study gathered data from a Swedish national pregnancy registry in order to evaluate the potentially harmful nature of fetal exposure to Paxil. According to researchers, women who took Paxil during 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 1.8-fold increased risk for congenital birth defects overall, and a 1.5-fold increased risk for heart defects, compared to infants whose mothers took other antidepressant drugs while pregnant.

The FDA issued another public health advisory in 2006 after a New England Journal of Medicine study found a six times increased risk of PPHN among infants exposed to SSRI antidepressants like Paxil after the twentieth week of pregnancy. PPHN, or persistent pulmonary hypertension of the newborn, is an extremely dangerous heart and lung condition in which a child’s circulation continues to bypass the lungs after birth, depriving the rest of the body of oxygen. The NEJM published two additional studies in 2007; the first of which determined that infants born to women who took an SSRI like Paxil during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like club foot, limb defects and anal atresia. Researchers also found a connection between SSRIs and cleft lip, cleft palate and neural tube birth defects. In the second study, researchers indicated that infants exposed to SSRIs like Paxil during pregnancy were more than twice as likely to develop catastrophic birth defects like anencephaly, craniosynostosis and omphalocele.

Paxil Use During Pregnancy

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. The FDA has also advised physicians 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. If you are currently taking Paxil and you are pregnant or planning to become pregnant, consult your physician as soon as possible. You should never stop taking a prescription medication without medical consent, as this may cause further harm to you or your child. However, with the help of your doctor, you may be able to find a safer alternative to Paxil for treating your condition.

Contact a Paxil Attorney for Help

Drug manufacturing companies like GlaxoSmithKline are responsible for the safety and effectiveness of their medications, even after they enter the market. They should also be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies deny liability for dangerous drug injuries in order to avoid negative consequences like a drug recall. If you or a loved one has suffered from cleft lip and you believe Paxil to be the cause, contact a Paxil attorney 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.

Filing a Paxil lawsuit or a potential Paxil class action lawsuit can be a complex process. Fortunately, Paxil lawyers are well-versed in defective drug litigation and can help victims of alleged Paxil birth defects protect their rights and collect the compensation they deserve. Defective drug lawsuits also bring public attention to the importance of safe medications and the need for more stringent regulations on the dangerous drugs already on the market. Consumers expect their prescription medications to effectively treat their condition without causing them any unreasonable harm. Unfortunately, some pharmaceutical companies are aware of the harmful nature of their drugs and intentionally conceal this information in order to avoid a drug recall. This deceptive practice puts millions of consumers at risk of suffering serious injury, illness and even death. With the help of a qualified Paxil attorney, you can stand up to big drug companies and feel confident that your case is in good hands.

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