Tegretol belongs to a class of pharmaceutical drugs called anticonvulsants, which have become one of the most effective methods of epilepsy treatment available. Although anticonvulsants like Tegretol were originally designed as a first line of defense against epileptic seizures, these drugs have been approved for additional purposes in recent years, and have even been prescribed for off-label uses in some cases. Tegretol was 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 functions by inhibiting nerve impulses in the brain which are responsible for causing seizures and pain. Since its introduction to the U.S. market, Tegretol has become an increasingly popular anticonvulsant, and is currently manufactured by Novartis Pharmaceuticals.
Although Tegretol and other anticonvulsants have been widely embraced by physicians across the country, these drugs have become the subject of significant scrutiny in recent years. Serious concerns have been raised about the safety of anticonvulsant drugs like Tegretol, especially in the treatment of pregnant women. According to an emerging body of research, women who take Tegretol during pregnancy may significantly increase their risk of giving birth to infants with major side effects, including birth defects like growth retardation.
Growth retardation is a birth defect diagnosed in fetuses that are underweight in regards to their gestational age. The growth of a fetus, which can be measured and assessed while the fetus is still in the womb, is considered healthy when there is a normal increase in size over time until the skeleton is fully fused. Children suffering from growth retardation however, are born at or below the tenth percentile in weight for their gestational age, meaning they are smaller than ninety percent of other children their same gestational age. Most instances of growth retardation occur during the third trimester, which makes the birth defect especially difficult to diagnose.
Growth retardation is typically defined as either symmetrical or asymmetrical. Symmetrical growth retardation occurs when the child displays poor growth of the head, abdomen and long bones, compared to asymmetrical growth retardation, in which the head and long bones develop properly, but the abdomen does not. The most common screen for determining growth retardation is estimating fetal weight, which is based on measurements of head circumference, femur length and abdominal circumference.
Growth retardation can result in serious complications if not promptly diagnosed and treated. Possible growth retardation treatment includes correcting reversible causes, discontinuing drug therapy if a pharmaceutical medication has caused the abnormal growth, and close monitoring of the fetus during the remainder of pregnancy. Some complications associated with growth retardation include abnormal neurological development, decreased cognitive function, and an increased risk of cardiovascular disease, high blood pressure and diabetes.
For several decades, researchers have conducted studies with the goal of evaluating the potentially harmful nature of anticonvulsant drugs like Tegretol. In 1989, the New England Journal of Medicine published a study in an attempt to determine whether and to what extent Tegretol is teratogenic, or likely to cause fetal malformations. According to researchers involved in the study, the teratogenicity of Tegretol was illustrated by the incidence of serious birth defects among infants whose mothers took the drug during pregnancy. Of the thirty-five children observed, 11% were born with craniofacial defects, 20% suffered from developmental delay, and 26% developed hypoplasia of the nails.
In 2001, the NEJM published an additional study in which researchers sought to examine the adverse side effects associated with fetal exposure to anticonvulsant drugs like Tegretol. Over 100,000 pregnant women were divided into groups based on extent of anticonvulsant exposure during pregnancy, and their children were observed for any serious side effects. Of the women who took only one anticonvulsant while pregnant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote). The report indicated that 20.6% of infants exposed to one anticonvulsant developed birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and 8.5% of unexposed infants. Among the birth defects observed were growth retardation, hypoplasia of the midface, hypoplasia of the fingers, spina bifida, and microcephaly. After reviewing these results, researchers concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero. Anticonvulsant birth defect studies are still being conducted in the U.S. and other countries in order to further identify the potentially harmful nature of these medications. In the meantime, these drugs 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 justify the potential risks to the fetus. This decision was based on the FDA’s classification of Tegretol as a pregnancy category D medication, the second highest category available in the evaluation of dangerous drugs. Category D is reserved for drugs which positive human evidence has shown may cause serious 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 to discuss alternative treatment options. You should never stop taking a prescription medication without medical consent, as this may cause further harm to you or your child. However, with your doctor’s help, you may be able to find a safer way to treat your condition.
Growth retardation affects approximately 100,000 infants in the United States each year. Unfortunately, this birth defect may result in significant fetal morbidity and mortality if not properly diagnosed. If you or a loved one has suffered from growth retardation which you believe to be associated with Tegretol, contact a qualified 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, the medical expenses associated with injury treatment, and the pain and suffering endured by you and your family. Victims of serious injuries resulting from the use of a potentially dangerous drug are not at fault and should not be held accountable for the resulting consequences. Drug companies like Novartis are responsible for the safety of their medications and should be held liable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies deny liability for dangerous drug injuries in order to protect themselves from a drug recall, or other negative consequences. The only way to protect your own rights and stand up to the deceptive practices of drug companies is to hire a Tegretol lawyer to represent your case.