Craniosynostosis - Consumer Justice Foundation


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Zoloft and Craniosynostosis Birth Defects

Antidepressant medications like Zoloft were originally developed as a first-line defense against depression, although the drugs have been indicated for additional purposes in recent years. One of the most common types of antidepressant drugs are SSRIs, or selective serotonin reuptake inhibitors, which function by balancing the level of serotonin in the brain, a neurotransmitter responsible for affecting mood. By doing so, these drugs can effectively relieve depression and improve certain mood disorders. Zoloft (sertraline) is currently manufactured by pharmaceutical giant, Pfizer Inc., and was approved by the FDA in 1991. Since its introduction, Zoloft has been approved for the treatment of major depression, panic disorder, post-traumatic stress disorder, obsessive-compulsive disorder, social anxiety disorder, and premenstrual dysphoric disorder.

Although Zoloft and other SSRI antidepressants have become increasingly prescribed by physicians across the country, recent research has identified these drugs as a potential risk factor for the development of major birth defects among infants. According to a number of studies, women who take SSRIs like Zoloft while pregnant may significantly increase their chances of giving birth to infants with one or more severe birth defects, including craniosynostosis.

What is Craniosynostosis?

Craniosynostosis is a craniofacial birth defect characterized by the premature closure of one or more cranial sutures on a child’s skull. Cranial sutures are the joints which connect the different parts of a child’s cranium. Because of presence of these sutures, the skull is able to expand in order to accommodate normal brain growth. Unfortunately, when these sutures close earlier than normal, that part of the skull loses its elasticity. While the affected portion of the skull will be unable to expand, the rest of the skull will, resulting in abnormal head growth. Other symptoms of craniosynostosis include a raised hard edge along the affected sutures, slow or lack of increase in head size over time, and absence of the fontanelle (soft spot on the child’s head). There are three main types of craniosynostosis, named for the sutures involved. Sagittal synostosis involves the main suture on the top of the head, frontal plagiocephaly involves the suture which runs from ear to ear on top of the head, and metopic synostosis involves the suture close to the forehead.

Craniosynostosis Treatment and Complications

The main method of treatment for children with craniosynostosis is reconstructive surgery, which can restore the appearance of the child’s head, relieve excessive pressure on the brain, and create enough space in the skull to allow for normal brain growth. With prompt treatment, children with craniosynostosis typically make a full recovery. Unfortunately, if this condition is left untreated, the malformation may become permanent and lead to serious complications like developmental delay, increased intracranial pressure and seizures.

FDA Warnings and Zoloft Birth Defect Studies

In 2006, the New England Journal of Medicine published a study in which researchers found a potential connection between the use of SSRI antidepressants and PPHN. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening 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 antidepressant like Zoloft during the third trimester of pregnancy were a shocking six times more likely to develop PPHN, compared to infants whose mothers took no antidepressants while pregnant. In response to these findings, the FDA issued a public health advisory that same year, warning patients and healthcare providers about the increased risk of PPHN among infants exposed to SSRIs in utero. The FDA also required all sponsors of SSRI drugs to change prescribing information to include the potential risk for PPHN.

In 2007, the NEJM published two additional studies in which researchers sought to examine the adverse effects of SSRI antidepressants on infants exposed to the drugs during pregnancy. According to the first study, infants born to women who took an SSRI antidepressant like Zoloft during the first trimester of pregnancy were nearly twice as likely to develop birth defects like anal atresia, limb defects and club foot. Researchers also found a potential connection between SSRIs and cleft lip, neural tube birth defects and cleft palate. The second study indicated that infants whose mothers took an SSRI while pregnant were more than twice as likely to develop devastating birth defects like craniosynostosis, anencephaly and omphalocele. In 2010, the American Journal of Nursing concluded that infants exposed to SSRIs like Zoloft during the first trimester of pregnancy were nearly twice as likely to be born with major heart defects, namely atrial septal defects and ventricular septal defects.

Zoloft Use During Pregnancy

The FDA has classified Zoloft as a pregnancy category C medication, a category reserved for medications which have the potential to cause serious harm to a human fetus when taken during pregnancy. If you are currently pregnant or planning to become pregnant and you are taking Zoloft, consult your physician to discuss alternative treatment options. It may be dangerous to suddenly discontinue use of a prescription medication, but with your doctor’s help, you may be able to find a safer way to treat your condition.

A Zoloft Attorney Can Help

Birth defects like craniosynostosis have the potential to cause significant pain and suffering for an affected child, as well as overwhelming financial difficulties for the child’s family. If you or a loved one has suffered from craniosynostosis and you believe Zoloft to be the cause, contact a Zoloft attorney, as you may have grounds to file a Zoloft lawsuit against Pfizer. The goal of Zoloft lawsuits and potential Zoloft class action lawsuits is to seek financial compensation for your injuries, the medical expenses associated with injury treatment, and the pain and suffering endured by you and your family. Defective drug lawsuits also bring public attention the allegedly harmful nature of certain medications, potentially preventing serious injuries in the future.

Victims of severe injuries caused by the use of a dangerous drug are not at fault, and should not be held accountable for the resulting consequences. Drug manufacturing companies like Pfizer are responsible for producing safe and effective drugs, and 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 avoid a drug recall, thereby putting millions of consumers at risk of suffering serious injury and even death. Only by hiring an experienced Zoloft lawyer to represent their case can victims of alleged Zoloft birth defects protect their rights and collect the compensation they deserve.

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