Tegretol is one of a group of pharmaceutical medications called anticonvulsants, which have become some of the most popular treatments for individuals suffering from epilepsy. Tegretol was approved by the FDA in 1974 and is commonly used in the treatment of epilepsy, bipolar disorder and neuropathic (nerve) pain. The active ingredient in Tegretol is carbamazepine, and the drug functions by decreasing certain nerve impulses in the brain which are responsible for causing seizures and pain. Tegretol is currently manufactured by Novartis Pharmaceuticals and has become one of the most commonly prescribed anticonvulsants on the market. Unfortunately, a number of studies have been conducted in recent years in which researchers have identified Tegretol use during pregnancy as a potential risk factor for the development of major birth defects among infants. Among these birth defects is a severe neural tube birth defect called spina bifida.
Spina bifida is an extremely serious neural tube birth defect occurring when the neural tube fails to close completely during fetal development. The neural tube is the precursor to the child’s central nervous system, and any malformation in this structure can result in serious, life-threatening damage to the brain and spinal cord. Spina bifida typically results in an opening in the vertebrae protecting the spinal cord through which, in severe cases, the spinal cord may actually protrude. Common symptoms of spina bifida include incontinence, paralysis, loss of sensation in parts of the body, hydrocephalus, and weakness in the legs, hips or feet.
The two most common types of spina bifida are spina bifida occulta and spina bifida cystica, which vary greatly in severity. Spina bifida occulta is the most common and least serious type of this condition, sometimes allowing affected children to live their entire lives without ever being diagnosed or requiring treatment. In children with spina bifida occulta, at least one vertebrae is typically malformed, but the spinal cord and nerves are intact. Spina bifida cystica, on the other hand, is the most serious type of this condition, characterized by a fluid-filled cyst which protrudes from the child’s back and may contain the spinal cord, membranes, or both. In some cases, the cyst may be covered by a thin layer of skin, and in other cases the spinal cord nerves may actually be exposed.
Most children born with spina bifida require surgery in order to repair the malformation. In some cases, the child may require a shunt if there is a build-up of fluid in the brain, or antibiotic treatment in order to prevent infections like a urinary tract infection or meningitis. Unfortunately, even with treatment, children with spina bifida typically require long-term medical care in order to carefully monitor development and prevent further complications, including intellectual, physical or neurological problems.
In 2001, the New England Journal of Medicine published a study in which researchers sought to examine the adverse effects of fetal exposure to anticonvulsant drugs like Tegretol. The study involved three groups of women: those who took one anticonvulsant while pregnant, those who took more than one anticonvulsant while pregnant, and those who received no anticonvulsant treatment during pregnancy. Of the women who took only one anticonvulsant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote). According to the study, 20.6% of infants exposed to one anticonvulsant were born with birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and 8.5% of unexposed infants. Among these anticonvulsant birth defects were spina bifida, growth retardation, microcephaly, hypoplasia of the fingers, and hypoplasia of the midface, among other malformations. One or more of these birth defects were present in 13.8% of infants whose mothers took Tegretol alone during pregnancy, and researchers also discovered that the prevalence of spina bifida was highest among infants whose mothers took Tegretol in combination with Depakote.
More recently, in 2010, the British Medical Journal published a study in which researchers found that women who take Tegretol while pregnant may significantly increase their chances of giving birth to infants with one or more major birth defects, particularly spina bifida. The study reviewed eight cohort studies involving 2,680 women who took Tegretol during pregnancy. According to researchers, 3.3% of infants exposed to Tegretol during the first trimester of pregnancy were born with serious malformations, including spina bifida. More specifically, infants born to women who took Tegretol during pregnancy were 2.6 times more likely to develop spina bifida, compared to infants whose mothers received no Tegretol treatment during pregnancy.
Tegretol has been classified by the FDA as a pregnancy category D medication, which means there is positive human evidence of the drug’s potential to cause serious harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoid prescribing Tegretol to pregnant women unless the possible benefits of the treatment justify the potential risks to the fetus. If you are currently taking Tegretol and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It is never advised to discontinue 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 way to treat your condition.
Spina bifida is an extremely serious birth defect, while can have life-long consequences for an affected child. Furthermore, seeking proper medical care for spina bifida is likely to result in costly medical expenses, which can be an overwhelming burden for many families. If you or a loved one has suffered from spina bifida and you believe Tegretol to be the cause, contact a Tegretol attorney to discuss the benefits of filing a Tegretol lawsuit against Novartis Pharmaceuticals. The goal of Tegretol lawsuits and potential Tegretol class action lawsuits is to seek financial compensation for your injuries, medical expenses, and pain and suffering. Defective drug lawsuits also bring much-needed attention to the potential hazards of certain medications, potentially preventing further injury or death in the future.
Victims of serious injury resulting from the proper use of a dangerous drug are not at fault. Pharmaceutical companies like Novartis are expected to manufacture and market safe medications, and are also expected to alert the public of any hazards potentially associated with their products. Unfortunately, some drug companies actually withhold this information, in a desperate attempt to avoid negative consequences, such as a drug recall. This deceptive practices exposes millions of consumers to serious injury, which could have been avoided had the drug company taken the appropriate steps to prevent unnecessary harm. The only way to protect your rights as a consumer and stand up to the dishonest practices of big drug companies is to hire a qualified Tegretol lawyer to represent your case.