Craniosynostosis - Consumer Justice Foundation


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Craniosynostosis and Prozac

Prozac is an SSRI antidepressant, or selective serotonin reuptake inhibitor, a class of drugs developed as a first-line defense against depression. These drugs work by increasing the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Prozac (fluoxetine) garnered FDA approval in 1987 and has since been approved for the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder and bulimia nervosa. Prozac is currently manufactured by pharmaceutical company, Eli Lilly and Company, and is one of the most popular antidepressants available. In fact, as of 2007, Prozac was the third most commonly prescribed antidepressant on the market, behind Zoloft and Lexapro, with 22.2 million prescriptions filled.

Despite the fact that SSRI drugs like Prozac have been embraced and widely prescribed by physicians across the country, recent research has identified the use of these drugs during pregnancy as a possible risk factor for the development of birth defects among infants. According to a number of studies, women who take Prozac or other SSRIs while pregnant may significantly increase their chances of giving birth to infants with one or more major birth defects, including craniosynostosis. Unfortunately, according to the Journal of the American Medical Association, more than 80,000 pregnant women are prescribed SSRI antidepressants like Prozac in the United States in any given year.

Craniosynostosis Described

Craniosynostosis is a craniofacial defect involving the skull, in which a child’s cranial sutures close earlier than normal. Cranial sutures are the joints which separate the different sections of the skull, allowing the skull to remain elastic enough to accommodate brain growth during infancy. When one or more of these sutures close prematurely, that part of the cranium loses its elasticity, but the rest of the skull will continue to expand, resulting in an abnormal head shape. There are different forms of this birth defect, named for the type of sutures involved. Frontal plagiocephaly occurs when one side of the suture running from ear to ear on top of the head is affected, sagittal synostosis involves the main suture on the top of the head, and metopic synostosis affects the suture close to the forehead. Although the most obvious symptom of craniosynostosis is irregular head growth, there are a number of other complications associated with this condition, including a raised hard ridge along the affected sutures, absence or early disappearance of the fontanelle (soft spot on the skull), and a lack of increase in head size over time.

Craniosynostosis Treatment and Prognosis

The main treatment for children born with craniosynostosis is reconstructive surgery, which is often performed during infancy. The goals of surgery are to improve the appearance of the child’s head, relieve pressure on the brain, and create enough space in the skull for future brain growth. Unfortunately, without treatment, craniosynostosis may become permanent, leading to life-threatening complications like seizures, developmental delay and excessive intracranial pressure.

FDA Warnings and Alleged Prozac Birth Defects

In 2007, the New England Journal of Medicine published two side effect studies concerning SSRI antidepressants like Prozac. According to one study, infants born to women who took an SSRI like Prozac during pregnancy were more than twice as likely to develop devastating birth defects like craniosynostosis, omphalocele and anencephaly. The other study indicated that women who took Prozac or other SSRIs during the first trimester of pregnancy were nearly twice as likely to give birth to infants with birth defects like anal atresia, club foot and limb defects. Researchers also found a potential connection between SSRIs and cleft palate, cleft lip and neural tube birth defects.

Previously, the NEJM published a revealing study in 2006 in which researchers examined the adverse side effects potentially associated with SSRIs like Prozac. According to the study, infants whose mothers took an SSRI after the twentieth week of pregnancy were a shocking six times more likely to develop PPHN, compared to unexposed infants. PPHN, or persistent pulmonary hypertension of the newborn, is a serious heart and lung condition in which a child’s circulation continues to bypass the lungs after birth. The report indicated that up to twelve out of 1,000 infants exposed to an SSRI in utero developed PPHN, compared to the expected rate among the general population, which is one to two infants out of 1,000. Months after this study was released, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of PPHN among infants exposed to an SSRI during pregnancy. The FDA also required all SSRI sponsors to change prescribing information to include the potential risk of PPHN.

Prozac Use During Pregnancy

The FDA has classified Prozac as a pregnancy category C medication, a category reserved for drugs with the potential to cause serious harm to a fetus when taken during pregnancy. If you are currently taking Prozac and you are pregnant or planning to become pregnant, consult your physician immediately. You should never suddenly stop taking a prescription medication, but with your doctor’s help, you may be able to find a safer way to treat your condition.

Contact a Prozac Attorney For Help

Craniosynostosis is an extremely serious birth defect, potentially leading to life-threatening complications for an affected child if left untreated. Other birth defects potentially associated with Prozac, including PPHN and neural tube birth defects, are equally dangerous and can even result in death. If you or a loved one has suffered from craniosynostosis or another birth defect, and you believe Prozac to be the cause, contact an experienced Prozac attorney to discuss the benefits of filing a Prozac lawsuit against Eli Lilly. The goal of Prozac lawsuits and potential Prozac class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering endured by you and your family.

Most consumers assume that their prescription medications are safe because they have been approved by the FDA. Unfortunately, even the FDA receives inaccurate drug information sometimes. In fact, some drug companies actually conceal the hazardous nature of their medications in order to expedite the FDA approval process and to make their product more quickly available to the public. This dishonest practice leaves millions of consumers vulnerable to serious injury and even death, which could have been avoided had the drug company taken the appropriate steps to prevent unnecessary harm. Only by hiring a qualified Prozac lawyer to represent their case can victims of potential Prozac birth defects protect their rights and collect the compensation they deserve.

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