Dilantin is a prescription anticonvulsant medication currently manufactured by Pfizer, Inc. The drug was originally approved by the FDA in 1953 and has since been prescribed to individuals suffering from grand mal and complex partial epileptic seizures, as well as seizures occurring during or after neurosurgery. The active ingredient in Dilantin is phenytoin sodium, and the drug works by slowing down impulses in the brain which cause seizures. Since its inception, Dilantin has become one of the most frequently prescribed anticonvulsant drugs on the U.S. market. However, Dilantin has become the subject of significant scrutiny in recent years, as studies have suggested that infants born to women who took the drug during pregnancy may have an increased risk of developing major birth defects. Some affected infants may be born with multiple malformations, which may make up a devastating condition called fetal hydantoin syndrome.
Fetal hydantoin syndrome is a rare disorder which may be associated with an infant’s exposure to the anticonvulsant drug, phenytoin (Dilantin). Fetal hydantoin syndrome describes a collection of defects which may include craniofacial defects like cleft lip and cleft palate, microcephaly (defect of the skull), growth retardation, hypoplasia of the nails, hypoplasia of the fingers, heart defects, developmental delay, limb defects and mental retardation. Fetal hydantoin syndrome is believed to be caused by the teratogenicity of phenytoin (Dilantin), which is defined as the ability of a drug to interfere with fetal development and cause fetal malformations. This disorder is believed to be so closely related to an infant’s exposure to Dilantin that it is sometimes even referred to as fetal dilantin syndrome.
In 2006, the journal Neurology published a study in which researchers sought to examine the adverse effects of certain anticonvulsants on infants exposed to the drugs in utero. The study involved 333 mother and child pairs, 110 of which were exposed to Tegretol, 98 of which were exposed to Lamictal, 69 of which were exposed to Depakote, and 56 of which were exposed to Dilantin. According to researchers, 20.3% of infants whose mothers took Depakote were born with severe birth defects, compared to 10.7% of infants exposed to Dilantin, 8.2% of infants exposed to Tegretol, and 1.0% of infants exposed to Lamictal.
The New England Journal of Medicine published a study in 2001 in which researchers identified anticonvulsant drugs as one of the most common causes of potential harm to a fetus in utero. In this study, over 100,000 women were screened over a seven-year period and divided into separate groups based on their level of anticonvulsant exposure. Among the women who used only one anticonvulsant while pregnant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproate (Depakote). According to the results, 20.6% of infants whose mothers took one anticonvulsant drug developed major birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and only 8.5% of unexposed infants. The birth defects included microcephaly (skull defect), growth retardation, spina bifida, limb defects, heart defects, anal atresia (missing or misplace opening to the anus), hypoplasia of the fingers, hypoplasia of the midface, cleft palate, cleft lip, and hypospadias (genital defect in males).
In 2008, the FDA added Dilantin to its “Potential Signs of Serious Risks” list, indicating a potential safety risk requiring further investigation. Despite these alleged dangers, Dilantin remains on the market today available to millions of consumers, including pregnant women, across the country.
Dilantin has been labeled a pregnancy category D medication by the FDA, a category reserved for drugs which positive human evidence has suggested may cause significant harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoid prescribing category D medications like Dilantin to pregnant women unless the possible benefits of the treatment justify the potential risks to the fetus. If you are currently taking Dilantin and you are pregnant or planning to become pregnant, consult your healthcare provider as soon as possible. It may be dangerous to terminate use of a prescription medication without medical consent, but with your doctor’s help, you may be able to find an alternative treatment option for your condition.
Children born with fetal hydantoin syndrome may struggle with devastating complications for the majority of their lives. Although treatment may be available for some of the malformations associated with this disorder, the child will likely require extensive, long-term care, which can result in exorbitant medical expenses. For a child physically compromised and a family already emotionally distressed, costly medical bills can present a significant financial burden. If you or a loved one has suffered from fetal hydantoin syndrome and you believe Dilantin to be the cause, contact a Dilantin attorney immediately. You may have grounds to file a Dilantin lawsuit against Pfizer in order to seek financial compensation for your injuries and medical expenses, as well as the pain and suffering endured by your family.
Pharmaceutical companies like Pfizer are responsible for the safety and effectiveness of their medications, even after they enter the market. They should also be held accountable for any serious injuries sustained by consumers of their products. Unfortunately, some drug manufacturing companies intentionally withhold the more serious side effects of their medications in order to protect themselves from negative consequences, such as a drug recall. This puts consumers at risk of suffering life-threatening injuries that could have been avoided had the manufacturing company taken the appropriate steps to protect consumers from harm. The only way for victims of alleged Dilantin birth defects to protect their rights and stand up to big drug companies is for them to hire a Dilantin lawyer to represent their case.