Dilantin is a prescription anticonvulsant medication manufactured by pharmaceutical giant, Pfizer, Inc. The drug was originally approved by the FDA in 1953 and has since been approved for the treatment of grand mal and complex partial seizures associated with epilepsy, as well as seizures occurring during or after neurosurgery. In some cases, physicians may prescribe Dilantin for off label purposes, which include anxiety control and mood stabilization. The active ingredient in Dilantin is phenytoin sodium, and the drug functions by slowing down impulses in the brain which are responsible for causing seizures.
Although Dilantin has become one of the most commonly prescribed anticonvulsant medications on the U.S. market, recent research has raised concerns about the safety of the drug, especially in treating pregnant women. According to some studies, women who take Dilantin while pregnant may significantly increase their risk of giving birth to infants with serious birth defects, including neural tube birth defects. Phenytoin, Dilantin’s active ingredient, is believed to interfere with the body’s ability to absorb folic acid, which is essential in the production of new cells. A reduction in folic acid may be linked to the development of neural tube birth defects, like spina bifida, among infants.
During the early stages of development in utero, certain embryonic cells fuse together to form the neural tube, the child’s precursor to the central nervous system which consists of the brain and spinal cord. Unfortunately, if this process it interrupted, a neural tube birth defect may occur, which can have life-threatening complications for an affected child. Neural tube birth defects are characterized by an opening in the spinal column or skull caused by the failure of the neural tube to close completely in utero. One of the most common types of neural tube birth defect is spina bifida.
Spina bifida occurs when one or more of the vertebrae overlying the spinal cord fail to fully fuse together, leaving an opening through which the spinal cord may actually protrude. The most common and least serious form of spina bifida is called spina bifida occulta. Children with this condition may exhibit no signs of the defect and sometimes live their entire lives without the malformation ever being detected. In many cases, the only visible representation of the defect is a small patch of hair or birthmark located at the site of the defect. One of the most severe forms of spina bifida is called spina bifida cystica, in which an affected child may be born with a fluid-filled cyst protruding from his back. This cyst may contain the spinal cord, membranes, or both.
The symptoms associated with neural tube birth defects depend largely upon the type, severity and location of the defect. In many cases, an affected child may experience incontinence, loss of sensation in parts of the body, paralysis in body parts located below the actual defect, a build-up of fluid in the brain (hydrocephalus), and developmental delay. Unfortunately, there is currently no cure for neural tube birth defects and any medical treatment is typically intended to manage the symptoms associated with the condition.
In 2001, the New England Journal of Medicine published a study in which researchers examined the adverse effects of in utero anticonvulsant exposure on infants. Over 100,000 women were screened at five Boston-area hospitals over a seven-year period and were then divided into separate groups based on level of anticonvulsant exposure during pregnancy. Among the group of women who took only one anticonvulsant drug while pregnant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproate (Depakote). The report indicated that 20.6% of infants exposed to one anticonvulsant drug in utero developed major malformations, compared to 28% of infants exposed to two or more anticonvulsants, and 8.5% of unexposed infants. The birth defects observed in the study included spina bifida, growth retardation, hypoplasia of the midface, hypoplasia of the fingers, cleft palate, cleft lip, anal atresia (missing or misplaced opening to the anus), limb defects, hypospadias (genital defect in males), heart defects, and microcephaly (defect of the skull). After reviewing the results of this study, researchers concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.
The journal Neurology published a 2006 study which compared the harmful effects of certain anticonvulsant medications on infants exposed to the drugs in utero. The study included 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 the report, 20.3% of infants born to women who took Depakote were born with major birth defects, compared to 10.7% of infants who were exposed to Dilantin, 8.2% of those exposed to Tegretol, and 1.0% of those exposed to Lamictal.
The FDA has classified Dilantin as a pregnancy category D medication, a category reserved for drugs which positive human evidence has shown can cause serious 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. The FDA has advised physicians to avoid prescribing category D medications like Dilantin to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus. It may be dangerous to discontinue use of a prescription medication without medical consent, but with your doctor’s help, you may be able to find an alternative method for treating your condition.
Unfortunately, neural tube birth defects are usually already established by 28 days of gestation, before many women are even aware they are pregnant. Because nearly half of all pregnancies are unplanned, all women of childbearing age who take anticonvulsant drugs like Dilantin may be at risk of causing irreversible harm to their unborn child. If you or a loved one has suffered from a neural tube birth defect like spina bifida, and you believe Dilantin to be the cause, contact a Dilantin attorney to discuss your legal options. You may have grounds to file a Dilantin lawsuit against Pfizer in order to seek financial compensation for your injuries, medical expenses and pain and suffering.
Victims of serious injury caused by the proper use of a dangerous drug are not at fault and should not be held accountable for the resulting consequences. Pharmaceutical companies are responsible for the safety of their medications and should be held liable for any adverse side effects sustained by consumers of their products. Unfortunately, this isn’t always the case. With the help of an experienced Dilantin lawyer, victims of alleged Dilantin birth defects can protect their rights and collect the compensation they deserve.