Dilantin falls into the category of anticonvulsant medications, which were originally developed as a treatment option for individuals struggling with epilepsy. Since the first anticonvulsant drug was introduced though, these medications have been indicated for additional uses and have even been prescribed for off-label purposes when physicians have deemed the treatment appropriate. Dilantin, for example, was approved by the FDA in 1953 and has since been prescribed to individuals suffering from complex partial or grand mal epileptic seizures, and seizures occurring during or after neurosurgery. The drug is also sometimes prescribed for the purpose of anxiety control and mood stabilization. The active ingredient in Dilantin is phenytoin sodium and the drug functions by interfering with certain impulses in the brain which are responsible for causing seizures. Dilantin is currently manufactured by pharmaceutical giant, Pfizer, Inc, and has become one of the most frequently prescribed anticonvulsants on the market.
Anticonvulsant medications like Dilantin have been the subject of significant scrutiny in recent years due to speculation that the drugs may be linked to birth defects in infants. According to some studies, women who take Dilantin during pregnancy may increase their risk of giving birth to infants with one or more birth defects, including growth retardation. The potentially harmful nature of Dilantin is believed to be due to its use of phenytoin, which is a known teratogen. Teratogenicity is defined as a drug’s potential to interrupt fetal development, resulting in fetal malformations. In 2008, the FDA added Dilantin to its “Potential Signs of Serious Risks” list, which means the agency had identified a potential risk factor requiring further study. Despite these alleged dangers, Dilantin remains on the market today.
Intrauterine growth retardation is diagnosed in children who are at or below the tenth percentile in weight for their gestational age. In other words, a child suffering from growth retardation is smaller than ninety percent of other fetuses his same gestational age. There are two types of growth retardation: symmetrical and asymmetrical. Symmetrical growth retardation is characterized by the equally poor growth of the child’s abdomen, head and long bones. Asymmetrical growth retardation involves poor growth of the head and long bones, but does not affect the abdomen. Growth retardation occurs when a fetus’ growth rate is abnormally slow. If not properly diagnosed, this condition can lead to further complications and, in some cases, even death.
One of the most revealing Dilantin birth defect studies was published in the New England Journal of Medicine in 2001 in which researchers sought to evaluate the potential connection between anticonvulsant use and birth defects. In this study, researchers screened over 100,000 pregnant women at five Boston-area hospitals between 1986 and 1993. These women were then divided into separate groups based upon anticonvulsant exposure during pregnancy. Among the women who took only one anticonvulsant while pregnant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproate (Depakote). According to the report, 20.6% of infants exposed to one anticonvulsant drug in utero were born with major 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 the study included growth retardation, spina bifida, hypoplasia of the fingers, hypoplasia of the midface, cleft lip, cleft palate, microcephaly (skull defect), heart defects, anal atresia (missing or misplaced opening to the anus), hypospadias (genital defect in males), and limb defects.
Another Dilantin birth defect study was published in the journal Neurology in 2006, an observational study comparing the harmful effects of anticonvulsant medications on infants exposed to the drugs in utero. Researchers observed the effects of in utero exposure to anticonvulsants like Dilantin, Tegretol, Depakote and Lamictal. 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. The report indicated that 20.3% of infants whose mothers took Depakote were born with serious birth defects, compared to 10.7% of those 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, 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. 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 a safer way to treat your medical condition. In the meantime, the FDA has advised healthcare providers 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.
Growth retardation is a serious condition which can affect a child for the rest of his life. Unfortunately, birth defects like growth retardation can also lead to costly medical expenses, which can be an overwhelming burden for an already emotionally compromised family. If you or a loved one has suffered from growth retardation and you believe Dilantin to be the cause, contact a Dilantin attorney as soon as possible. You may be entitled to reimbursement for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Dilantin lawsuit against Pfizer, Inc.
Drug manufacturing companies like Pfizer are responsible for the safety of their medications, even after they enter the market, and they should be held accountable for any serious injuries sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally withhold dangerous drug information from the FDA and from the public in order to avoid negative consequences, like a drug recall. This exposes consumers to life-altering injury, illness or even death, which could be avoided if manufacturing companies took the appropriate steps to alert the public of drug dangers. 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.