Cleft Lip - Consumer Justice Foundation

Cleft Lip

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Cleft Lip and Tegretol

Tegretol belongs to a class of pharmaceutical medications called anticonvulsants, which were initially designed as the first line of defense against epilepsy. Since the first anticonvulsant was introduced to the market, these drugs have been indicated for additional purposes, and have even been prescribed for off-label uses when physicians deem the treatment appropriate. Tegretol, for example, garnered FDA approval in 1974 and has since been approved for the treatment of epilepsy, neuropathic (nerve) pain, and the manic phase of bipolar disorder. Tegretol (carbamazepine) functions by inhibiting nerve impulses in the brain responsible for causing pain and seizure-related episodes, and the drug is currently manufactured by Novartis Pharmaceuticals. Since its inception, Tegretol has become one of the most popular anticonvulsant drugs available. Unfortunately, an emerging body of research has identified Tegretol use during pregnancy as a potential risk factor for the development of serious birth defects among infants, including a craniofacial defect called cleft lip.

Cleft Lip Described

Cleft lip is a birth defect involving a malformation of the upper lip during fetal development. Under normal circumstances, a child’s lips are fully formed between the fourth and seventh weeks of gestation. When there is a lack of tissue in the lip area during this time, however, a cleft lip may occur. This defect is characterized by a vertical fissure in one or both sides of the upper lip, which may even extend up through the nose in severe cases.

Cleft Lip Treatment and Complications

Children born with a cleft lip are at risk of suffering significant complications associated with the malformation. In some cases, the child may experience feeding difficulties as a result of fluids passing easily from the mouth back through the nose. Children with a cleft lip are also more prone to having fluid build up in their ears, resulting in chronic ear infections and even hearing loss. Dental issues like missing or malformed teeth, and difficulty with speech and language development are also common side effects among infants with a cleft lip. The only way to permanently repair a cleft lip is for the child to undergo corrective surgery, often followed by long-term medical care to monitor the child’s development and to prevent further complications.

Tegretol Birth Defect Studies

One of the more recent Tegretol birth defect studies was published in the British Medical Journal in 2010. The study involved a review of eight cohort studies in which the children of 2,680 women who took Tegretol while pregnant were observed for adverse side effects. According to researchers, 3.3% of infants whose mothers took Tegretol during the first trimester of pregnancy were born with major birth defects. In addition, infants exposed to Tegretol in utero were 2.6 times more likely to develop spina bifida, compared to unexposed infants. Researchers concluded that women who take Tegretol while pregnant may significantly increase their chances of giving birth to infants with major birth defects, namely spina bifida.

The potentially harmful nature of anticonvulsants like Tegretol has been apparent for several years. In 1989, the New England Journal of Medicine published a study in an attempt to determine whether and to what extent Tegretol is teratogenic, defined as a drug’s potential to interrupt fetal development and cause fetal malformations. According to researchers, the teratogenicity of Tegretol was illustrated by the incidence of birth defects among infants exposed to the drug in utero. Of the thirty-five children observed, 11% were born with craniofacial defects like cleft lip and cleft palate, 26% developed hypoplasia of the nails, and 20% experienced developmental delay.

In 2001, the NEJM published an additional study in which researchers evaluated the teratogenicity of Tegretol and other anticonvulsant drugs. The study observed over 100,000 pregnant women who were split into groups based upon exposure to anticonvulsant drugs: one group consisted of women who took one anticonvulsant while pregnant, one group consisted of women who took two or more anticonvulsants while pregnant, and one group consisted of women who received no anticonvulsant treatment during pregnancy. Of the women who took one anticonvulsant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote). According to researchers, the prevalence of birth defects among infants exposed to one anticonvulsant was 20.6%, compared to the prevalence among infants exposed to two or more, which was 28%, and the prevalence among unexposed infants, which was 8.5%. Among the observed birth defects were growth retardation, spina bifida, hypoplasia of the fingers, hypoplasia of the midface, and microcephaly. Researchers also found that these birth defects were present among 13.8% of infants exposed to Tegretol alone in utero, concluding that anticonvulsant drugs like Tegretol are one of the most common causes of potential harm to a fetus in utero.

Tegretol While Pregnant

The FDA has classified Tegretol as a pregnancy category D medication, which means the drug has the potential to cause significant, unreasonable harm to a fetus when taken during pregnancy. Because of this, 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 healthcare provider as soon as possible. It may be dangerous to suddenly discontinue use of a prescription medication, but with your doctor’s help you may be able to find a safer alternative to Tegretol for treating your medical condition.

A Tegretol Attorney Can Help

Although birth defects like cleft lip can typically be effectively treated with surgery, the cost of seeking proper medical care for birth defects often leads to exorbitant medical expenses. Unfortunately, for families already emotionally distressed by a birth defect diagnosis, this financial burden can be difficult to shoulder. If you or a loved one has suffered from a birth defect and you believe Tegretol to be the cause, contact a Tegretol attorney as soon as possible. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Tegretol lawsuit against Novartis Pharmaceuticals. Tegretol lawsuits and potential Tegretol class action lawsuits also bring public attention to the importance of safe medications and the need for more harsh regulations on the dangerous drugs currently on the market.

Birth defect victims are not at fault and should not be responsible for the resulting consequences. Drug companies like Novartis are expected to produce safe and effective medications, and should be held liable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies deny liability in personal injury cases in order to shield themselves from negative consequences, such as a drug recall. Not only does this deceptive practice prevent injury victims from receiving the compensation they deserve, it also exposes millions of other consumers to serious injury without their knowledge. Only by hiring a qualified Tegretol lawyer to represent their case can victims of alleged Tegretol birth defects protect their rights and collect the compensation they deserve.

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