Craniosynostosis and Zoloft

Craniosynostosis is a birth defect in which a baby's skull fuses prematurely and causes abnormal head growth. SSRI antidepressants such as Zoloft may be linked to the development of craniosynostosis in babies whose mothers took the medication during pregnancy.

The class of antidepressant medications known as selective serotonin reuptake inhibitors, or SSRIs, has been the subject of significant scrutiny in recent years because of a potential link between the use of the drugs during pregnancy and the development of major birth defects in infants. SSRIs function by restoring the balance of serotonin in the brain, which can relieve depression and improve certain mood disorders. Unfortunately, recent andtidepressant side effect research has indicated a possible connection between these SSRI antidepressants and birth defects like persistent pulmonary hypertension of the newborn (PPHN), heart defects, limb defects, anal atresia, cleft palate, cleft lip, omphalocele, neural tube birth defects and craniosynostosis.

One of the most widely-prescribed forms of SSRIs is a drug called Zoloft, which has been on the U.S. market since 1991. The active ingredient in Zoloft is sertraline, an antidepressant drug which has been FDA-approved to treat depression, panic attacks, premenstrual dysphoric disorder, social anxiety disorder, and post-traumatic stress disorder in adults, as well as severe cases of obsessive-compulsive disorder in adults and children ages six and older. Zoloft is currently manufactured by the pharmaceutical company, Pfizer, and since its inception has become one of the most widely-prescribed antidepressant drugs available. In fact, in 2007, Zoloft was the most prescribed antidepressant on the market, with 29,652,000 prescriptions filled.

Craniosynostosis Described

Craniosynostosis is a birth defect which causes an affected infant's cranial sutures to close earlier than normal, causing the head to grow abnormally. Cranial sutures are connections or joints which separate individual cranial bones and allow the skull to remain elastic enough to accommodate brain growth after birth. When these sutures close too early however, that particular part of the cranium will lose its elasticity, but the skull will still attempt to expand in order to allow for normal brain growth. The result is a misshapen head.

Craniosynostosis Symptoms

The symptoms associated with craniosynostosis depend largely upon the type of sutures involved. If the child's main suture on the top of the head is affected, the condition is qualified as sagittal synostosis. If one side of the suture running from ear to ear on the top of the head closes early, the condition is called frontal plagiocephaly. If the affected suture is the one located close to the forehead, the child may suffer from metopic synostosis. Regardless of the specific type of craniosynostosis, the common symptoms associated with this birth defect are:

• Abnormal head shape
• A raised hard edge along the affected sutures
• Absence of the fontanelle (soft spot on the child's head)
• Slow or lack of increase in head size over time

Craniosynostosis Treatment and Complications

Surgery is required in order to correct craniosynostosis, and is typically performed during infancy. The main goal of craniosynostosis treatment is to improve the appearance of the child's head, relieve pressure on the brain, and create enough room in the skull to accommodate normal brain growth. Infants with this condition typically make a full recovery after surgery. Unfortunately, if craniosynostosis is left untreated, the defect may be severe and permanent. Additional complications may also occur, including seizures, increased intracranial pressure, and developmental delay.

Zoloft and Birth Defects

The most significant antidepressant side effect study involving the potential connection between the use of SSRI antidepressant drugs like Zoloft and birth defects in infants was published in the New England Journal of Medicine in 2006. According to the report, the risk of infants developing a potentially fatal heart and lung condition called PPHN after exposure to an SSRI was six times the rate among infants not exposed to these drugs in utero. Researchers determined that up to twelve out of 1,000 infants whose mothers took an SSRI like Zoloft after the twentieth week of pregnancy developed PPHN shortly after birth, compared to what would be expected among infants who are not exposed, which is one to two per 1,000 infants. Almost immediately after this study was released, the FDA issued a health advisory warning patients and health professionals about the potential side effect connection between SSRI antidepressant use and the risk of PPHN. The FDA also required all SSRI sponsors to update their drugs' warning labels to include potential pregnancy precautions, including PPHN.

Another side effect study published in the American Journal of Nursing in 2010 suggested a potential connection between the use of SSRIs like Zoloft and an increased risk of heart defects among infants, namely atrial septal defects and ventricular septal defects. This particular side effects of antidepressants study involved 1,370 women who took an SSRI like Zoloft during the first trimester of pregnancy and 493,113 women who took no antidepressants while pregnant. According to researchers, the prevalence of septal heart defects among infants exposed to an SSRI in utero was 0.9%, compared to the prevalence among the general population, which was 0.5%. This birth defect risk was even higher among infants who were exposed to more than one SSRI during pregnancy. Other studies suggested a possible link between SSRI use and additional birth defects.

Zoloft Use During Pregnancy

Zoloft has been labeled by the FDA as a pregnancy category C medication, which means it may cause harm to a human fetus as a side effect if taken during pregnancy. If you are currently taking Zoloft and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It is never advised to terminate use of a prescription medication without medical consent, but with the help of your doctor you may be able to find a safer alternative to Zoloft for treating your medical condition. The FDA has advised patients and healthcare professionals to carefully consider all benefits and risks involved in taking Zoloft during pregnancy before deciding whether to continue or discontinue use of the medication.

A Craniosynostosis Attorney Can Help

If you or a loved one has suffered craniosynostosis and you believe the antidepressant drug Zoloft to be the cause, contact a Zoloft attorney to discuss your legal options. Victims of serious injury potentially resulting from side effects of using Zoloft are not at fault and may be entitled to reimbursement by filing a Zoloft lawsuit. The goal of Zoloft lawsuits and potential Zoloft class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering incurred by you and your family. By filing a defective drug lawsuit or joining a class action lawsuit, potential Zoloft birth defect victims can also bring considerable attention to the importance of safe medications and the need for more stringent regulations on the potentially dangerous drugs already on the market. Victims of alleged Zoloft birth defects are not at fault, and with the help of an experienced Zoloft lawyer, you can feel confident that your case is in good hands.