Tegretol is one of a group of pharmaceutical drugs called anticonvulsants, which have become widely prescribed in the United States and other countries for the treatment of epilepsy. Tegretol was initially approved by the FDA in 1974 and has since been approved for the treatment of epilepsy, bipolar disorder, and neuropathic (nerve) pain. The active ingredient in Tegretol is carbamazepine, and the drug works by inhibiting certain nerve impulses in the brain which cause seizures and pain. Tegretol is currently manufactured by Novartis Pharmaceuticals and is becoming increasingly popular on the U.S. market. According to the Journal of the American Medical Association, the number of anticonvulsant drugs on the market has increased dramatically since the 1990s. Unfortunately, in light of recent anticonvulsant side effect studies, Tegretol and other anticonvulsants may no longer be considered safe in the treatment of pregnant women. According to these studies, infants born to women who take Tegretol during pregnancy may have a considerably increased risk of suffering from birth defects, including dangerous skeletal birth defects.
Skeletal defects are malformations of a child’s skeletal structure, resulting from the failure of the skeleton to form correctly during fetal development. Under normal circumstances, a fetus’ skeleton is initially composed of soft cartilage which later hardens into bone. When there is an interruption in this process however, a fetus’ bones may not develop properly, resulting in a skeletal birth defect. Skeletal malformations can present in any number of ways, the most common being defects of the limbs and defects of the skull.
Limb defects are characterized by the underdevelopment of an entire upper or lower limb, or a portion of the limb. Some of the most common limb defects include an arm, leg, foot, hand, finger or toe that is absent, extra, or abnormally small or large. Limb defects are typically classified as the following: complete or partial absence of the limb or digit, overgrowth (the limb is larger than normal), undergrowth (the limb is smaller than normal), failure to separate (commonly, webbed fingers or toes), duplication (extra fingers or toes), or constriction band syndrome (a constricting band of tissue forms around the limb and cuts off tissue growth and blood flow).
Defects of the skull are particularly dangerous because they often involve the absence or underdevelopment of portions of the cranium. In some cases, this type of defect may be accompanied by a malformation of critical parts of the brain as well, which can have significant adverse consequences for infants. Two of the most common types of skull defects are craniosynostosis and microcephaly, both of which present serious dangers to the affected child. Craniosynotosis occurs when a child’s cranial sutures close prematurely, resulting in abnormal head growth and excessive pressure on the brain, which can cause seizures and developmental delay. Microcephaly is a dangerous birth defect commonly diagnosed in children who are born with an abnormally small head, due to the failure of the brain to grow at a normal rate. Children born with microcephaly have an increased risk of suffering from delays in speech and motor functions, seizures, mental retardation, and other neurological problems.
In 1989, a study was published in the New England Journal of Medicine which sought to evaluate the potential teratogenicity of the anticonvulsant drug, Tegretol. According to researchers, Tegretol’s teratogenicity, or potential to cause fetal malformations, was effectively illustrated by the presence of birth defects among infants exposed to the drug during pregnancy. Of the thirty-five children observed in this study, 11% were born with craniofacial defects like cleft palate and cleft lip, 26% were born with hypoplasia of the nails, and 20% experienced delays in development.
In 2001, the NEJM published an additional study with similar results. Researchers observed over 100,000 women who became pregnant while taking an anticonvulsant drug, and divided these women into groups based on extent of anticonvulsant exposure. Of the women who took only one anticonvulsant during pregnancy, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote). According to the report, the prevalence of birth defects among infants exposed to one anticonvulsant was 20.6%, compared to 28% among infants exposed to two or more anticonvulsants, and 8.5% among unexposed infants. Among the side effects observed in this study were birth defects like microcephaly, spina bifida, growth retardation, hypoplasia of the midface, and hypoplasia of the fingers.
More recently, in 2010, the British Medical Journal published a Tegretol side effect study in which researchers reviewed eight cohort studies involving 2,680 pregnant women exposed to Tegretol. According to the study, 3.3% of infants exposed to Tegretol during the first trimester of pregnancy were born with major birth defects, including spina bifida. In fact, infants exposed to Tegretol in utero were 2.6 times more likely to develop spina bifida compared to unexposed infants. Despite this potential for harm, Tegretol and a number of other anticonvulsants remain on the market, available to millions of consumers across the country.
The FDA has advised physicians to avoid prescribing Tegretol to pregnant women unless the possible benefits of the treatment outweigh the potential risks to the fetus. This safety notice was issued as a result of the FDA’s classification of the drug as a pregnancy category D medication. This means there is positive human evidence of the potential for Tegretol to cause serious, unreasonable harm to a fetus when taken during pregnancy. If you are currently taking Tegretol and you are pregnant or planning to become pregnant, consult your healthcare provider immediately. It is never encouraged to terminate use of a prescription medication without medical consent, as this may cause further harm to you or your child. However, with the help of your doctor, you may be able to find a safer alternative to Tegretol for treating your condition.
Skeletal birth defects have the potential to cause serious complications for an affected child, especially defects of the skull like craniosynostosis and microcephaly. While some limb defects can be repaired with surgery without fear of further complications, skull defects can lead to severe damage sometimes requiring life-long treatment. Unfortunately, seeking proper medical care for birth defect victims typically results in costly medical bills, which can be an overwhelming burden for many families. If you or a loved one has suffered from a skeletal birth defect, which you believe to be associated with Tegretol, contact an experienced Tegretol attorney to discuss your legal options. You may be entitled to financial compensation for your injuries and medical expenses, which you can collect by filing a Tegretol lawsuit against Novartis Pharmaceuticals. Defective drug lawsuits are also important because they bring much-needed attention to the allegedly harmful nature of certain medications, potentially preventing dangerous drug-related injury and death in the future.
If you took Tegretol while pregnant and your child was born with a serious birth defect, you are not at fault. Drug companies like Novartis are expected to produce safe medications, and are also expected to notify consumers of any possible hazards associated with their products. Unfortunately, some pharmaceutical companies intentionally conceal this information, in an attempt to avoid negative consequences, such as a drug recall. This misleading practice exposes millions of consumers to serious injury, which could have been avoided had the drug company taken the appropriate steps to avoid unnecessary harm. Only by hiring a knowledgeable Tegretol lawyer can victims of alleged Tegretol birth defects protect themselves from further harm and collect the compensation they deserve.