Epilepsy is a severe brain disorder involving repeated spontaneous seizures, of which there are several different types. Seizures occur as a result of abnormal electrical activity in the brain, causing involuntary changes in sensation, body movement or function, behavior or awareness. According to the Centers for Disease Control and Prevention, about two million Americans struggle with epilepsy, with more then 140,000 new cases diagnosed each year. Epilepsy is so prevalent and devastating that the condition results in an estimated annual cost of $15.5 billion in medical expenses and loss or reduced earnings. Epilepsy is an extremely debilitating condition, and treatment for pregnant women with epilepsy has presented a serious challenge to healthcare providers for many years. In order to treat epilepsy or seizures, many people are prescribed anticonvulsant medications like Tegretol. However, while seizures during pregnancy may cause harm to both mother and child, taking anticonvulsant drugs to prevent these seizures is very likely to cause irreparable damage to the exposed fetus.
Despite the popularity of anticonvulsant drugs like Tegretol in treating epilepsy and other conditions, extensive research has indicated that taking these medications during pregnancy may significantly increase a woman’s chances of giving birth to an infant with major birth defects. Among these alleged Tegretol birth defects are:
While some of these birth defects, like cleft lip and cleft palate, can typically be treated successfully with surgery, others, like skeletal defects and spina bifida, have the potential to cause serious complications for an affected child. In cases of a severe malformations, birth defects may even lead to death shortly after the child is born.
Despite the fact that the potentially harmful nature of anticonvulsant drugs like Tegretol has been evident for several years, a large number of these medications remain on the market today. In 1989, the New England Journal of Medicine published a study in which researchers sought to examine whether and to what extent Tegretol is teratogenic, a term defined as a drug’s ability to interfere with fetal development, resulting in fetal malformations. According to the report, the teratogenicity of Tegretol was effectively illustrated by the incidence of birth defects among infants exposed to the drug during pregnancy. Of the thirty-five children observed, 11% developed craniofacial defects like cleft lip and cleft palate, 20% suffered from developmental delay, and 26% were born with hypoplasia of the nails.
In 2001, the NEJM published another revealing study in which research examined the teratogenicity of anticonvulsant drugs like Tegretol. In the 1970s and 1980s, the anticonvulsant drugs used most commonly to prevent seizures, including phenytoin (Dilantin) and carbamazepine (Tegretol), were found to cause major malformations among infants exposed to the drugs during pregnancy, such as growth retardation, microcephaly, and abnormalities of the face and fingers. In the NEJM report, researchers evaluated the adverse effects of fetal exposure to Depakote, Dilantin and Tegretol, and discovered that the prevalence of major birth defects among infants exposed to one anticonvulsant drug was 20.6%, compared to the prevalence among infants exposed to two or more anticonvulsants (28%), and the prevalence among unexposed infants, which was 8.5%. Researchers involved in this study concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.
In 2010, the British Medical Journal published a study in which researchers reviewed eight cohort studies involving 2,680 pregnancies in which the mother took carbamazepine (Tegretol) while pregnant. According to the study, 3.3% of women who took Tegretol during the first trimester of pregnancy gave birth to infants with major birth defects. Furthermore, the risk of spina bifida among infants exposed to Tegretol in utero was 2.6 times the risk among unexposed infants, indicating that women who take Tegretol during pregnancy may significantly increase their risk of giving birth to infants with one or more serious malformations, namely spina bifida.
The FDA has classified Tegretol as a pregnancy category D medication, which means there is positive human evidence illustrating 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 immediately. You should never stop taking a prescription medication without medical consent, as this may cause further harm to you or your child, but with your doctor’s help, you may be able to find a safer way to treat your condition.
According to national estimates, 20-35% of women with epilepsy suffer from seizures more often during pregnancy, which can be extremely dangerous for both mother and child. Unfortunately, the anticonvulsant drugs which have been approved for the treatment of epilepsy may cause severe and even life-threatening malformations among infants exposed to the medications during pregnancy. If you or a loved one has suffered from a birth defect which you believe to be associated with the use of Tegretol, contact a Tegretol attorney as soon as possible. You may be entitled to financial reimbursement for your injuries and medical expenses, which you can collect by filing a Tegretol lawsuit against Novartis Pharmaceuticals. Another goal of Tegretol lawsuits and potential Tegretol class action lawsuits is to bring public attention to the importance of safe medications and the need for more stringent regulations on the dangerous drugs currently on the market.
Most consumers understand that no drug is 100% safe, but they do expect their pharmaceutical medication to treat their condition without causing them any unnecessary harm. Unfortunately, there are a number of drugs currently on the market for which the possible benefits are actually outweighed by the potential risks to the fetus. Unfortunately, some drug companies conceal this information from the public in an attempt to make their product more desirable to consumers. This deceptive practice exposes millions of consumers to serious injury and even death, just by taking their prescriptions medications. The only way to protect your rights and stand up to big drug companies is to hire an experienced Tegretol lawyer to represent your case.