Cleft Palate - Consumer Justice Foundation

Cleft Palate

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Cleft Palate and Tegretol

Tegretol is one of a group of pharmaceutical medications called anticonvulsants and is currently manufactured by Novartis Pharmaceuticals. Anticonvulsant drugs were originally designed specifically to treat epilepsy, although recent years have led to a more generous use of these medications. Tegretol, for example, 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 works by reducing certain nerve impulses in the brain which cause seizures and pain. Although Tegretol and other anticonvulsant drugs have become increasingly popular in recent years and are now widely prescribed by physicians across the country, a number of studies have indicated that these drugs may not be safe in treating pregnant women. According to several reports, women who take anticonvulsant drugs like Tegretol during pregnancy may significantly increase their risk of giving birth to infants with one or more serious birth defects, including cleft palate.

Cleft Palate Described

A cleft palate is a craniofacial birth defect in which a child’s palate, or roof of the mouth, fails to form properly in utero. During normal fetal development, a child’s palate is formed after the fifth week of gestation. However, when there isn’t enough tissue in the palate area as the structure is being formed, a cleft may occur. A cleft palate is characterized by an opening in the roof of the mouth and can involve the soft back portion of the mouth or the bony front portion of the mouth. In some cases, the cleft may be so severe that it causes a nearly complete separation of the roof of the mouth.

Cleft Palate Treatment and Prognosis

The most common method of treatment for children with cleft palate is reconstructive surgery in order to repair the malformation. With treatment, most affected children make a full recovery, although they may require long-term care in order to monitor their development and prevent any further difficulties. Unfortunately, there are a number of complications associated with cleft palate in infants who do not receive treatment. Because of the separation in the roof of the mouth, food and liquids can pass easily from the mouth back through the nose causing severe feeding difficulties for affected children. Children with a cleft palate are also more prone to having fluid build up in their ears, causing recurring ear infections and sometimes even hearing loss. Other side effects commonly linked to cleft palate are dental issues like missing or misaligned teeth, and delays in speech and language development.

Alleged Tegretol Birth Defects and FDA Warnings

In 1989, a study was published in the New England Journal of Medicine in which researchers sought to determine whether and to what extent Tegretol is teratogenic. Teratogenicity is defined as the potential for a drug to interfere with fetal development, resulting in fetal malformations. According to researchers, the teratogenicity of Tegretol was illustrated by the major birth defects present in infants exposed to the drug during pregnancy. Of the thirty-five children observed, 11% were born with craniofacial defects like cleft lip or cleft palate, 26% were born with hypoplasia of the nails, and 20% suffered from developmental delay.

In 2001, the NEJM published another study in which researchers ultimately concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero. The study involved over 100,000 pregnant women who were divided into groups based on exposure to anticonvulsants during pregnancy. One group consisted of women who took one anticonvulsant while pregnant, one group consisted of women who took two or more, and one group consisted of women who were not exposed to any anticonvulsants while pregnant. 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 report, 20.6% of infants exposed to one anticonvulsant were born with birth defects, compared to 28% of infants exposed to more than one anticonvulsant, and 8.5% of unexposed infants. These alleged Tegretol birth defects included growth retardation, microcephaly, spina bifida, hypoplasia of the midface and hypoplasia of the fingers, among other side effects.

In 2010, the British Medical Journal published a study in an attempt to examine the teratogenicity of Tegretol, defined as the potential for the drug to interfere with fetal development and cause major side effects among exposed infants. The study reviewed eight cohort studies involving 2,680 women who took Tegretol during pregnancy, and the children of these women were observed for adverse side effects. According to researchers, 3.3% of women who took Tegretol during the first trimester of pregnancy were born with major birth defects, and infants exposed to Tegretol in utero were 2.6 times more likely to develop spina bifida, a devastating neural tube birth defect. In light of alleged Tegretol birth defect information, 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.

Tegretol Use While Pregnant

The FDA has labeled Tegretol 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. If you are currently pregnant or planning to become pregnant, and you are taking Tegretol, consult your healthcare provider immediately to discuss alternative treatment options. You should never stop taking a prescription medication without medical consent, as this can cause further harm to you or your child. With your doctor’s help, you may be able to find a safe and effective way to treat your condition.

Contact a Tegretol Attorney for Help

Research has indicated that taking anticonvulsant drugs like Tegretol during pregnancy can lead to serious adverse side effects, namely major birth defects among exposed infants. Unfortunately, some of these birth defects are irreversible, plaguing affected children with difficulties throughout their entire lives. In some cases, birth defects can be treated and possibly even reversed, although the medical costs associated with birth injury treatment are typically an overwhelming expense for victims and their families. If you or a loved one has suffered from a birth defect and you believe Tegretol to be the cause, contact an experienced Tegretol attorney to discuss your legal options. 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.

Regardless of the fact that it is the responsibility of drug companies to supply consumers with accurate information about potential drug hazards, some pharmaceutical companies intentionally conceal this information in order to make their product more desirable to the public. This exposes millions of consumers to serious injury and even death, which could have been avoided had the drug company taken the appropriate steps to avoid unnecessary harm. What’s more, most consumers assume that their insurance company will protect them from further harm following an accident or birth defect diagnosis. Unfortunately, some insurance claims adjusters are actually trained to deny personal injury claims or to offer a settlement far below what the victim is entitled to, in order to save the company money. In some cases, the claims adjuster may simply drag the claim out over a long period of time in hopes that the victim will simply give up. These deceptive practices not only prevent injury victims from collecting the compensation they deserve, they also prevent other consumers from obtaining accurate drug information, which they need in order to make an educated decision to continue or discontinue use of a pharmaceutical drug. The only way to protect your rights and stand up to dishonest drug companies and insurance companies is to hire a qualified Tegretol lawyer to represent your case.

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