Anticonvulsant medications were originally developed as a treatment for individuals suffering from epilepsy. Since the first of these drugs was introduced though, anticonvulsants have been indicated for additional uses and have even been prescribed for off-label purposes as physicians have seen fit. Dilantin, for example, was approved by the FDA in 1953 and has since been used in the treatment of grand mal and complex partial epileptic seizures, as well as seizures occurring during or after neurosurgery. In some cases, Dilantin may be prescribed as an agent for mood stabilization or anxiety control, if appropriate. The active ingredient in Dilantin is phenytoin sodium, and the drug functions by slowing down certain impulses in the brain which are responsible for causing seizure-related episodes. Dilantin is currently manufactured by pharmaceutical company, Pfizer, Inc.
Despite the fact that Dilantin has become an extremely popular method of epilepsy treatment since its inception, recent studies have raised concerns about the safety of the drug. According to research, women who take Dilantin during pregnancy may increase their risk of giving birth to infants with serious birth defects, including mental retardation. In 2008, the FDA added Dilantin to its “Potential Signs of Serious Risks” list, meaning the agency had identified a potential safety issue requiring further investigation. More information regarding potential Dilantin birth defects and the process of filing a Dilantin birth defect lawsuit can be found below.
Mental retardation is a condition characterized by below-average general intellectual function and a lack of the skills necessary for daily living. Mental retardation is typically diagnosed before age 18 and affects approximately 1-3% of the population. Individuals with mental retardation often struggle with delays in the development of motor skills, language skills, and self-help skills. Common symptoms of this condition include:
The main goal of treatment for mental retardation is to develop the individual’s potential to the fullest. In some cases, with special education and training, affected individuals may be able to lead productive lives and function on their own.
The allegedly harmful nature of anticonvulsant drugs has been evident for several years. In 2001, the New England Journal of Medicine published a study in which researchers identified anticonvulsant use during pregnancy as a risk factor for the development of major birth defects among infants. Researchers involved in this study screened over 100,000 women over a seven-year period and divided them into separate groups based upon extent of anticonvulsant exposure. Among the 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 serious birth defects, compared to 28% of infants exposed to two or more anticonvulsants, and only 8.5% of unexposed infants. The birth defects observed in infants included spina bifida, hypoplasia of the fingers, hypoplasia of the midface, cleft lip, cleft palate, hypospadias (genital defect in males), limb defects, heart defects, anal atresia (missing or misplaced opening of the anus), growth retardation, and microcephaly (skull defect). After reviewing these results, researchers concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero.
Another study published in the journal Neurology in 2006 observed the harmful effects of certain anticonvulsant drugs on infants exposed to the medications during pregnancy. Researchers observed the effects of in utero exposure to anticonvulsants like Tegretol, Dilantin, Depakote and Lamictal. Involved in the study were 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 developed major 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 FDA has classified Dilantin as a pregnancy 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. If you are currently taking Dilantin and you are pregnant or planning to become pregnant, consult your physician as soon as possible. You should never stop taking a prescription medication without medical consent, as this may cause further damage. However, with the help of your doctor, you may be able to find a safer alternative to Dilantin for treating your condition.
Dilantin’s active ingredient, phenytoin, is believed to be dangerous partly because it may inhibit the body’s ability to properly absorb folic acid, which is essential in the production of new cells. Infants who don’t receive enough folic acid during pregnancy have an increased risk of developing neural tube birth defects like spina bifida, which can cause damage to the brain and spinal cord. Individuals with spina bifida and other neural tube birth defects often struggle with complications like paralysis, incontinence, learning disabilities, and mental retardation. Although most women receive enough folic acid through leafy vegetables, bread and vitamins, women with epilepsy who take anticonvulsant medications may be at risk of reduced folic acid levels. These women are encouraged to take folic acid supplements in order to prevent fetal malformations.
Victims of serious injury or illness resulting from the use of a dangerous drug are not at fault and may be entitled to reimbursement for their injuries. Drug manufacturing companies like Pfizer are responsible for the safety of their medications and should be held accountable for any adverse side effects sustained by consumers of their products. If you or a loved one has suffered from a birth defect like mental retardation, which you believe to be associated with the use of Dilantin, 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, medical expenses, and pain and suffering.
Following a birth defect diagnosis, the victim’s family should be given adequate time to concentrate on seeking proper medical care for the child without having to worry about filing a birth defect lawsuit as well. Regrettably, many birth defects require extensive, long-term treatment, which can lead to costly medical expenses. Fortunately, Dilantin lawyers are extremely well-versed in defective drug litigation and can help victims and their families collect the compensation they deserve. With the help of a qualified Dilantin attorney, alleged Dilantin birth defect victims can feel confident that their case is in good hands.