Dilantin is one of a group of drugs called anticonvulsants, which function by slowing down certain impulses in the brain which are responsible for causing seizure-related episodes. The active ingredient in Dilantin is phenytoin sodium, and the drug has been approved for the treatment of grand mal and complex partial seizures associated with epilepsy, and seizures occurring during or after neurosurgery. Dilantin was originally approved by the FDA in 1953 and is currently manufactured by Pfizer, Inc. Despite the fact that Dilantin has become one of the first lines of defense against epilepsy, the safety of this and other anticonvulsant drugs have been doubted in recent years. According to some studies, women who take Dilantin during pregnancy may significantly increase their risk of giving birth to infants with life-altering birth defects, including heart defects. More information concerning potential Dilantin birth defects, and the process of filing a Dilantin lawsuit for injuries sustained during the use of Dilantin, can be found below.
A heart defect is a congenital birth defect involving the incomplete development of the heart during the early stages of pregnancy. Heart defects typically affect the flow of blood through the heart and can involve the interior walls of the heart, the valves inside the heart, or the arteries and veins which carry blood to and from the heart. Most heart defects either obstruct the flow of blood through the heart or cause blood to travel through the heart in an irregular pattern. While some heart defects are simple and may never be detected, others are dangerous and require immediate medical treatment in order to prevent further life-threatening complications.
Congenital heart defects commonly compromise the heart’s ability to pump blood throughout the body and deliver oxygen to the body’s organs and tissues. These birth defects typically result in clear symptoms like:
In 2006, the journal Neurology published a study in which researchers compared the adverse effects of different anticonvulsant medications on infants exposed to the drugs during pregnancy. Researchers observed 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 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 potentially harmful nature of Dilantin has been apparent for several years. In 2001, the New England Journal of Medicine published a study in which researchers concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero. Researchers involved in the study screened over 100,000 pregnant women at five Boston-area hospitals between 1986 and 1993, and divided the women into separate groups based on 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 Depakote. The report indicated that 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 anticonvulsants, and only 8.5% of infants exposed to no anticonvulsants during pregnancy. Among the birth defects observed were heart defects, growth retardation, limb defects, anal atresia (missing or misplaced opening to the anus), hypoplasia of the fingers, hypoplasia of the midface, hypospadias (genital defect in males), cleft palate, cleft lip, microcephaly (defect of the skull), and spina bifida. Despite these alleged dangers, it wasn’t until 2008 that the FDA added Dilantin to its “Potential Signs of Serious Risks” list, indicating that the agency had identified a potential safety risk which required further investigation.
The FDA has classified Dilantin as a pregnancy category D medication, which means there is positive human evidence illustrating 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 outweigh the potential risks to the fetus. If you are currently pregnant or planning to become pregnant, and you are taking Dilantin, consult your healthcare provider immediately. You should never stop taking a prescription medication without medical consent, but with the help of your doctor, you may be able to find a safer alternative to Dilantin for treating your medical condition.
Approximately eight out of every 1,000 infants are born with a congenital heart defect in the United States alone. While some heart defects may require little to no treatment, others may require long-term medical care in order to treat the condition and manage the accompanying symptoms. Unfortunately, extensive medical treatment typically results in costly medical bills, which can be an overwhelming burden for a family already emotionally distressed by a birth defect diagnosis. If you or a loved one has suffered from a heart defect and you believe Dilantin to be the cause, contact a Dilantin attorney to discuss the benefits of filing a Dilantin lawsuit against Pfizer, Inc. The goal of Dilantin lawsuits and potential Dilantin class action lawsuits is to seek financial compensation for your injuries and medical expenses, as well as the pain and suffering endured by you and your family. Defective drug lawsuits also bring public attention to the importance of safe medications and the need for more stringent regulations on the potentially dangerous drugs already on the market.
Victims of serious injury or illness potentially associated with the use of a prescription medication are not at fault and should not be held responsible for the resulting consequences. Drug manufacturing companies are expected to produce safe and effective drugs, and should be held liable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally conceal the more serious side effects of their medications in order to expedite the FDA approval process and ensure their drug is well-received by the public. This puts consumers at risk of suffering life-threatening injuries just by taking their prescription medications. The only way to protect your rights and stand up to big drug companies is to hire a Dilantin lawyer to represent your case. Dilantin lawyers are well-versed in defective drug litigation and can help victims of alleged Dilantin birth defects collect the compensation they deserve.