Cleft Lip - Consumer Justice Foundation

Cleft Lip

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Dilantin and Cleft Lip

Dilantin is a prescription medication which falls into the category of anticonvulsants, medications originally developed as a first-line defense against epilepsy. However, since the first anticonvulsant drug was approved by the FDA, these medications have also been indicated for additional purpose and have even been prescribed for off-label purposes as physicians have seen fit. Dilantin, for example, garnered FDA approval in 1953 and has since been prescribed to individuals suffering from grand mal or complex partial seizures associated with epilepsy, as well as seizures occurring during or after neurosurgery. In some cases, Dilantin may also be prescribed for off-label uses like mood stabilization and anxiety control. Dilantin, currently manufactured by Pfizer, Inc., contains the active ingredient phenytoin sodium, and functions by inhibiting the firing of certain impulses in the brain responsible for triggering seizures.

Since its inception nearly sixty years ago, Dilantin has become one of the most frequently prescribed anticonvulsant drugs on the U.S. market. Unfortunately, Dilantin and other anticonvulsant medications have been the subject of scrutiny in recent years because of a potential connection between the use of the drugs during pregnancy and the development of birth defects among infants. According to some studies, women who take Dilantin while pregnant may increase their risk of giving birth to infants with serious birth defects, including cleft lip.

Cleft Lip Described

Cleft lip is a congenital birth defect further classified as a craniofacial malformation, a category which includes defects of the face and skull. A cleft lip occurs when the formation of a child’s lip is interrupted during the early stages of fetal development, preventing the lip from fully fusing together. This defect is characterized by a vertical fissure in the upper lip which can occur on one or both sides of the mouth and, in severe cases, may even extend up through the nose.

Cleft Lip Treatment and Additional Medical Care

Because children with a cleft lip may have an opening between the nose and mouth, it is likely that they will struggle during feeding, as liquids may pass from the mouth back through the nose. Infants born with this defect may also suffer from additional complications commonly associated with a cleft lip, including frequent ear infections and hearing loss caused by a build up of fluid in the ears, missing or malformed teeth, and speech and language delay. In order to correct the defect and restore the function and appearance of the child’s lip, reconstructive surgery is necessary. Once this procedure is performed, the child may require long-term dental and orthodontic care in order to promote normal development and prevent further problems.

Dilantin Birth Defect Studies

The New England Journal of Medicine published a study in 2001 which sought to examine the adverse effects of anticonvulsant use on infants exposed to the drugs during pregnancy. Researchers screened over 100,000 pregnant women at five maternity hospitals between the years of 1986 and 1993 in order to determine the extent of anticonvulsant exposure. These women were then divided into separate groups, which included women who took one anticonvulsant while pregnant, women who took two or more anticonvulsants during pregnancy, and women who received no anticonvulsant treatment while pregnant. Among the women who took only one anticonvulsant drug during pregnancy, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote), among other drugs. According to the report, 20.6% of infants exposed to one anticonvulsant drug in utero were born with major birth defects. In comparison, 28% of infants exposed to more than one anticonvulsant drug and only 8.5% of unexposed infants developed severe malformations. Among these birth defects were cleft lip, cleft palate, spina bifida, microcephaly (skull defect), growth retardation, heart defects, limb defects, anal atresia (absent or misplaced opening to the anus), hypoplasia of the fingers, hypoplasia of the midface, and hypospadias (genital defect in male infants). Ultimately, researchers involved in the study concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.

In addition, in 2008, the FDA added Dilantin to its “Potential Signs of Serious Risks” list, which means the FDA had identified a potential safety issue requiring further examination. Despite these dangers, Dilantin remains on the market today, available to millions of consumers across the country, including pregnant women.

Dilantin Use While Pregnant

Dilantin has been labeled by the FDA as a pregnancy category D medication, which means there is positive human evidence suggesting that the drug may cause harm to a fetus when taken during pregnancy. If you are currently taking Dilantin and you are pregnant or planning to become pregnant, consult your physician as soon as possible. In the meantime, the FDA has advised physicians to avoid prescribing pregnancy category D medications like Dilantin to pregnant women unless the possible benefits of the treatment outweigh the potential risks to the fetus.

Contact a Dilantin Attorney for Help

Birth defects like cleft lip have the potential to cause significant pain and suffering for an affected child, requiring extensive and costly medical treatment. If you or a loved one has suffered from cleft lip and you believe the anticonvulsant drug Dilantin to be the cause, contact a Dilantin attorney to review your claim. You may have grounds to file a Dilantin lawsuit or join a potential Dilantin class action lawsuit against Pfizer in order to seek financial compensation for your injuries and medical expenses, as well as the pain and suffering endured by you and your family.

Pharmaceutical companies are expected to produce safe and effective medications, and to alert consumers of any potential deviations from these expectations. Unfortunately, some drug manufacturing companies intentionally withhold information concerning the harmful nature of their medications in order to avoid negative consequences, particularly a drug recall. This leaves millions of consumers vulnerable to suffering devastating injury, illness, or even death, simply by taking their prescription medications. Victims of adverse side effects or major birth defects resulting from the use of a dangerous drug are not at fault. The only way to protect your rights and stand up to big drug companies is to hire an experienced Dilantin lawyer to represent your case.

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