Tegretol belongs to a class of pharmaceutical medications called anticonvulsants, the first of which was developed in the late 1930s. These drugs were originally designed as a primary treatment for individuals with epilepsy, although many have been approved for additional purposes and some are even prescribed for off-label purposes. Tegretol is currently manufactured by Novartis Pharmaceuticals, and the drug garnered FDA approval in 1974. Since its inception, Tegretol has been approved to treat epileptic seizures, the manic phase of bipolar disorder, and neuropathic (nerve) pain. The active ingredient in Tegretol is carbamazepine, and the drug works by inhibiting certain impulses in the brain responsible for causing seizures and pain.
Despite the popularity of Tegretol and other anticonvulsants in treating epilepsy, serious concerns have been raised about the safety of these drugs, especially in the treatment of pregnant women. Epilepsy is an extremely debilitating condition, which poses serious dangers for both mother and child during pregnancy. Unfortunately, the drugs which are currently considered the most effective treatment for epilepsy, anticonvulsants, have been identified as potential risk factors for the development of major birth defects among infants. According to extensive research, women who take anticonvulsant drugs like Tegretol while pregnant may significantly increase their risk of giving birth to infants with one or more serious birth defects, including hypospadias.
Hypospadias is a congenital birth defect affecting male infants in which the genitals fail to form properly during fetal development. In infants born with hypospadias, the opening to the urethra is located on the underside of the penis, rather than at the end. In less severe cases, the opening may be located at least near the tip of the penis; more serious cases are characterized by an opening located at the mid-shaft or base of the penis, or even in or behind the scrotum. Children with hypospadias typically suffer from side effects like a downward curvature of the penis, abnormal spraying during urination, and a malformed foreskin which makes the penis look hooded.
The primary method of treatment for children with hypospadias is reconstructive surgery which can effectively correct the defect and restore the normal function of the child’s genitals. During surgery, the penis is straightened and the defect is repaired using a tissue graft from the infant’s foreskin. Infants suffering from hypospadias often make a full recovery after surgery, which is typically performed before the child reaches eighteen months of age. Unfortunately, without treatment, children born with this condition may suffer from additional complications in the future, including difficulty during toilet training and problems with sexual intercourse later in life.
One of the most significant anticonvulsant side effect studies was published in the New England Journal of Medicine in 2001. Researchers involved in this study observed over 100,000 women who were exposed to an anticonvulsant during pregnancy, and divided these women into separate groups based on the extent of their anticonvulsant exposure. Of the women who took only one anticonvulsant while pregnant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote). According to the report, 20.6% of infants exposed to one anticonvulsant in utero were born with birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and 8.5% of infants exposed to no anticonvulsants.
The NEJM published another important birth defect study in 1989, in which researchers concentrated on the adverse side effects of fetal exposure to Tegretol in particular. Of the thirty-five children observed in this study, 11% were born with craniofacial defects, 20% suffered from developmental delay, and 26% developed hypoplasia of the nails. According to researchers, the teratogenicity (potential for a drug to interfere with fetal development and cause fetal malformations) of Tegretol was illustrated by the incidence of birth defects among infants exposed to the drug in utero.
In 2010, the British Medical Journal published a study in which researchers observed the health of infants born to 2,680 women who took Tegretol during pregnancy. According to the study, 3.3% of infants whose mothers took Tegretol during the first trimester of pregnancy developed major birth defects, including spina bifida. More specifically, children exposed to Tegretol in utero were 2.6 times more likely to be born with spina bifida, compared to unexposed infants. Despite these alleged dangers, Tegretol and other anticonvulsant drugs remain on the market today, with few restrictions in place to protect consumers from unnecessary harm.
The FDA has classified Tegretol as a pregnancy category D medication, the second most serious category available for measuring the potential danger of pharmaceutical drugs. The FDA has also advised healthcare providers 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 may be dangerous to suddenly discontinue use of a prescription medication without medical consent, but with your doctor’s help, you may be able to find a safer way to treat your condition.
Genital defects like hypospadias have the potential to cause serious pain and suffering for an affected child. Although defects of this kind can typically be effectively treated with surgery, seeking proper medical care is likely to result in costly medical expenses, which can be a difficult burden to shoulder for many families. Drug companies who produce and market dangerous drugs should be held accountable for these medical costs. Unfortunately, some pharmaceutical companies deny liability for dangerous drug injuries in an attempt to avoid negative consequences, such as a drug recall. If you or a loved one was born with hypospadias and you believe Tegretol to be the cause, contact a qualified Tegretol attorney to discuss your legal options. You may have grounds to file a Tegretol lawsuit against Novartis Pharmaceuticals, in order to seek financial compensation for your injuries, medical expenses, and pain and suffering. Too often, injury victims are taken advantage of by deceptive corporations during their time of need. With the help of an experienced Tegretol lawyer, victims of alleged Tegretol birth defects can protect their rights and stand up to big drug companies.