Craniosynostosis - Consumer Justice Foundation

Craniosynostosis

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Effexor and Craniosynostosis

Effexor is a prescription antidepressant medication which falls into the category of SNRIs, or serotonin-norepinephrine reuptake inhibitors. The active ingredient in Effexor is venlafaxine, and the drug functions by inhibiting the “reuptake” of serotonin and norepinephrine, two neurotransmitters in the brain responsible for affecting mood. Effexor was approved by the FDA in 1993 for the treatment of major depressive disorder, social anxiety disorder and generalized anxiety disorder, although the drug is commonly used for off-label purposes as well, including treatment for diabetic neuropathy and panic disorder. Effexor is currently manufactured by Wyeth Pharmaceuticals, a division of Pfizer, and has become one of the most commonly prescribed antidepressant drugs on the U.S. market.

Despite the popularity of Effexor in treating depression and other mood disorders, a number of studies published in recent years have suggested a potential connection between the use of certain antidepressant drugs and the development of major birth defects, like craniosynostosis. Although the majority of these antidepressant birth defect studies have concentrated on SSRI (selective serotonin reuptake inhibitor) antidepressants in particular, the similarity between these drugs and SNRIs may allow experts to examine these studies in order to evaluate the potentially harmful nature of SNRIs like Effexor.

Craniosynostosis Signs and Symptoms

Craniosynostosis is a congenital birth defect in which a child’s cranial sutures close earlier than normal, resulting in abnormal head growth. Cranial sutures are the joints which connect the different parts of a child’s skull and contribute to the skull’s elasticity, which is essential in allowing the skull to accommodate normal brain growth in early childhood. In children with craniosynostosis, one or more of these sutures closes prematurely, preventing that part of the cranium from expanding as the brain grows. Other parts of the skull will continue to grow however, resulting in an irregularly shaped head. Common symptoms of craniosynostosis include:

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

There are different types of craniosynostosis, named for the type of sutures involved. For cases in which the the main suture on the top of the head is affected, sagittal synostosis may be diagnosed. If one side of the suture which runs from ear to ear on top of the head is affected, the condition is called frontal plagiocephaly, while metopic synostosis involves the suture located close to the forehead.

Craniosynostosis Treatment and Prognosis

The only way to correct craniosynostosis is for the child to undergo reconstructive surgery. The main goals of surgery are to restore the appearance of a child’s head, relieve pressure on the brain, and create enough space in the skull to allow for normal brain growth. With surgery, children born with this birth defect typically make a full recovery. However, without treatment, this condition may become permanent and lead to serious complications like increased intracranial pressure, developmental delay and seizures.

Effexor and Birth Defect Studies

In 2006, the FDA issued a public health advisory warning patients and healthcare professionals about the potential connection between the use of SSRI antidepressant drugs and the development of PPHN among infants exposed to the drugs during pregnancy. 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, depriving the body of its essential oxygen supply. This safety notice was issued on the heels of a 2006 study published by the New England Journal of Medicine in which researchers determined that infants whose mothers took certain antidepressant drugs after the twentieth week of pregnancy were an alarming six times more likely to develop PPHN. The FDA has since also required all SSRI sponsors to update their drug warning labels to include potential pregnancy precautions, namely PPHN.

A number of other antidepressant birth defect studies have been published in recent years in which researchers have sought to examine the adverse effects of antidepressant use on infants exposed to the drugs in utero. In 2007, the NEJM published two additional studies, the first of which suggested that infants born to women who took certain antidepressant drugs during the first trimester of pregnancy were nearly twice as likely to suffer from birth defects like club foot, limb defects, and anal atresia. Researchers also found a possible connection between the use of these antidepressants and cleft palate, cleft lip and neural tube birth defects. According to the second study, infants exposed to certain antidepressant drugs in utero were more than twice as likely to suffer from catastrophic birth defects including craniosynostosis, omphalocele and anencephaly. Another study published in 2010 in the American Journal of Nursing indicated a potential connection between the use of certain antidepressant drugs and heart defects, particularly atrial and ventricular septal defects.

Effexor Use and Pregnancy

The FDA has labeled Effexor a pregnancy category C medication, which means it has the potential to cause serious harm to a human fetus when taken during pregnancy. If you are currently taking Effexor and you are pregnant or planning to become pregnant, consult your physician immediately. It may be dangerous to discontinue use of a prescription medication without medical consent, as this may cause further harm to your or your child, but with your doctor’s help, you may be able to find an alternative treatment option.

Contact an Effexor Attorney for Help

Birth defects like craniosynostosis can be treated, but are likely to cause serious and even life-threatening complications for an affected child. If you or a loved one has suffered from craniosynostosis and you believe Effexor to be the cause, contact an experienced Effexor attorney to discuss your legal options. You may have grounds to file an Effexor lawsuit against Wyeth Pharmaceuticals (Pfizer) in order 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 to the importance of safe medications and the need for more stringent regulations on the dangerous drugs already on the market.

Victims of serious injuries allegedly caused by the use of a dangerous drug are not at fault and should not be held responsible for the negative consequences associated with their injuries. Drug manufacturing companies are expected to produce and market safe medications and are also expected to alert the public of any dangers potentially associated with their drugs. Unfortunately, some pharmaceutical companies intentionally withhold this information in order to avoid negative consequences like a drug recall, thereby disregarding the safety and well-being of the public. The only way to protect your rights and collect the compensation you deserve is to hire an Effexor attorney to represent your case.

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