Paxil - Craniosynostosis - Consumer Justice Foundation

Paxil – Craniosynostosis

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Paxil and Craniosynostosis Birth Defects

Recent research has indicated that SSRI antidepressants like Paxil may not be safe in treating pregnant women. A number of antidepressant birth defect studies have been conducted in recent years in which researchers have suggested that women who take SSRI antidepressants like Paxil while pregnant may significantly increase their risk of giving birth to infants with major birth defects, including a craniofacial defect called craniosynostosis. Unfortunately, according to the Journal of the American Medical Association, over 80,000 pregnant women in the U.S. are prescribed SSRI antidepressants in any given year.

Paxil is a prescription antidepressant medication known as an SSRI, or selective serotonin reuptake inhibitor. The active ingredient in Paxil is paroxetine, and the drug functions by restoring balance to the level of serotonin in the brain, thereby relieving depression and improving other mood disorders. Paxil was originally approved by the FDA in 1992 for the treatment of major depressive disorder, in 1996 for 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. Paxil is currently manufactured by GlaxoSmithKline and has become one of the most widely prescribed antidepressants on the U.S. market.

Craniosynostosis Signs and Symptoms

When a child is born, the different parts of the skull are connected by cranial sutures. These sutures are critical in allowing the skull to remain elastic enough to accommodate normal brain growth. Once the brain is finished growing, these sutures will close and the child’s head will no longer be able to expand. In children with craniosynostosis however, one or more of these cranial sutures close earlier than normal and prevent that part of the skull from growing, but the other parts will continue to expand. This results in a misshapen head.

There are different kinds of craniosynostosis, which are named for the type of sutures involved. Sagittal craniosynostosis involves the main suture on the top of the head, frontal plagiocephaly affects the suture running from ear to ear on the top of the head, and metopic synostosis involves the suture close to the forehead. Besides an abnormal head shape, children with this condition may also exhibit symptoms like:

  • A raised ridge along the affected sutures
  • Absence of the fontanelle (soft spot) on the child’s head
  • Failure of head size to increase over time

Craniosynostosis Treatment and Complications

The main method of treatment for children with craniosynostosis is surgery in order to repair the appearance of the child’s head, to relieve any excess pressure on the brain, and to make sure there is enough room in the skull to allow the brain to grow normally. Treatment does depend on several factors though, including the number of sutures affected, the amount of damage sustained by the child, and the potential involvement of other congenital defects. Without treatment, the malformation may become permanent and can result in complications like increased intracranial pressure, seizures, developmental delay, mental retardation and blindness.

Alleged Paxil Birth Defects and FDA Warnings

In 2005, the FDA issued a public health advisory warning patients and healthcare providers about the potential connection between the use of paroxetine (Paxil) during pregnancy and an increased risk of congenital birth defects, particularly heart defects. With this notice, the FDA also increased the pregnancy category of Paxil from C to D. These FDA warnings were instituted in response to 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, infants born to women who took Paxil in early pregnancy were nearly twice as likely to be born with a heart defect, compared to the risk among 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 of developing heart defects and a 1.8-fold increased risk of suffering from congenital birth defects overall, compared to infants exposed to other antidepressants during pregnancy.

In 2006, the FDA issued another public health advisory in response to new information provided by the New England Journal of Medicine concerning potential Paxil dangers, and warned patients and healthcare providers about the increased risk of PPHN among infants exposed to SSRI antidepressants in utero. According to the study, infants whose mothers took SSRIs like Paxil after the twentieth week of pregnancy were an alarming six times more likely to develop PPHN. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening heart and lung condition in which the child’s circulation continues to bypass the lungs after birth, depriving the rest of the body of oxygen.

In 2007, the NEJM published two additional studies in which researchers sought to examine the potentially harmful nature of SSRIs like Paxil. According to the first study, infants whose mothers took an SSRI 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 possible connection between SSRIs and cleft palate, cleft lip and neural tube birth defects. The second study indicated that infants born to women who took an SSRI like Paxil during pregnancy were more than twice as likely to develop devastating birth defects like omphalocele, craniosynostosis and anencephaly.

Paxil Use While Pregnant

The FDA has elevated Paxil’s pregnancy category from C to D, which means there is positive human evidence illustrating 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 physician as soon as possible. You should never suddenly stop taking a prescription medication, as this may cause further harm 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.

Contact a Paxil Attorney for Help

Birth defects like craniosynostosis have the potential to cause serious, life-altering complications for an affected child. In addition, the necessary treatment for children with this malformation is likely to result in costly medical expenses for the victim’s family. If you or a loved one has suffered from craniosynostosis and you believe Paxil to be the cause, contact a Paxil attorney to discuss your legal options. 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 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, there are some drugs currently on the market whose possible benefits may actually be outweighed by the drug’s potential for causing harm. In fact, some pharmaceutical companies are aware of the hazards associated with their medications and intentionally conceal this information in order to avoid negative consequences, such as a drug recall. This misleading practice exposes millions of consumers to serious injury and even death, just by taking their prescription medications. Defective drug litigation can be a complicated process; with the help of an experienced Paxil lawyer, victims of alleged Paxil birth defects can feel confident that their case is in good hands.

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