Dilantin is a prescription anticonvulsant drug which was originally developed as a treatment for individuals suffering from seizures and other seizure-related disorders. 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. Dilantin was approved by the FDA in 1953 specifically to prevent grand mal and complex partial seizures associated with epilepsy, although the drug is also often prescribed for off-label purposes like anxiety control and mood stabilization, when physicians deem Dilantin treatment appropriate. Dilantin is also indicated for the prevention and treatment of seizures occurring during or following neurosurgery. Dilantin is currently manufactured by Pfizer, Inc. and can be found in 30mg and 100mg extended oral capsules.
Phenytoin (Dilantin) has been associated with an increased risk of life-threatening conditions like Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). SJS is a devastating skin condition in which cell death causes the epidermis to separate from the dermis, most often caused by hypersensitivity of the skin and mucous membranes to certain pharmaceutical medications. Individuals with SJS typically present with mild symptoms like fever, fatigue and sore throat, which quickly progress into a rash or blisters covering the body, and may even lead to the death and shedding of the top layer of skin in severe instances. Individuals with SJS often experience devastating and potentially fatal complications, including permanent skin damage, organ damage, renal failure, blindness, and respiratory failure. Some experts believe that TEN is a more advanced form of SJS, as the symptoms of the conditions are similar, but TEN is characterized by the loss of a larger percentage of the body’s epidermis. TEN is also most often caused by a severe reaction to certain pharmaceutical medications, resulting in the separation of the epidermis from the dermis all over the body.
The allegedly increased risk of major birth defects among infants exposed to Dilantin in utero is believed to be associated with the drug containing the ingredient phenytoin. Phenytoin is a known teratogen, which describes any drug with the ability to interrupt fetal development and cause fetal malformations. The teratogenicity of many drugs is believed to be due to the drugs’ potential to inhibit folic acid absorption, which can interfere with the formation of blood vessels and cause fetal malformations like neural tube birth defects. Some of the birth defects potentially associated with the use of phenytoin (Dilantin) include:
According to a revealing 2001 study published by the New England Journal of Medicine, infants who are exposed to anticonvulsant drugs during pregnancy may have an increased risk of developing one or more major birth defects, compared to infants who are not exposed to these drugs in utero. Researchers involved in this study screened over 100,000 pregnant women at five Boston-area hospitals between 1986 and 1993 and divided the women into separate groups based upon anticonvulsant exposure. According to the report, 20.6% of infants exposed to one anticonvulsant drug during pregnancy were born with major birth defects, compared to 28% of infants exposed to two or more anticonvulsants in utero, and 8.5% of unexposed infants. Among the women who took only one anticonvulsant drug while pregnant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote), among other drugs. The birth defects observed among infants exposed to one or more of these anticonvulsant medications included microcephaly (defect of the skull), limb defects, anal atresia (absent or misplaced opening to the anus), hypospadias (genital defect in males), heart defects, cleft lip, cleft palate, growth retardation, hypoplasia of the midface, hypoplasia of the fingers, and spina bifida. After reviewing these results, researchers concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.
The FDA has classified Dilantin as a pregnacy category D medication, which means there is positive human evidence of the drug’s potential to cause serious 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 drug justify the potential risks to the fetus. If you are currently taking Dilantin and you are pregnat or planning to become pregnant, consult your healthcare provider as soon as possible. It may be dangerous to suddenly discontinue use of a prescription drug without medical consent, but with your doctor’s help, you may be able to find a safer way to treat your condition.
Dilantin and other anticonvulsant medications may cause devastating side effects like SJS and TEN, as well as catastrophic birth defects for individuals exposed to the drug in utero. If you or a loved one has suffered from a birth defect which you believe to be associated with the use of Dilantin, 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, the medical expenses associated with injury treatment, and the pain and suffering endured by you and your family.
You are not responsible for serious injuries resulting from the use of a dangerous drug. Pharmaceutical companies should be held accountable for the safety of their medications and for any adverse side effects sustained by consumers of their products. Unfortunately, many drug manufacturing companies operate in their own best interest, disregarding the safety of millions of consumers. Defective drug litigation can be a complicated process, but with the help of an experienced Dilantin lawyer, victims of alleged Dilantin birth defects can protect their rights and collect the reimbursement they are entitled to.