pregnancy category D medications like Dilantin should only be prescribed to pregnant women if the possible benefits of the treatment justify the potential risks to the fetus
(Vocus/PRWEB) April 11, 2011
Recent research has indicated that women who take Dilantin while pregnant may increase their risk of giving birth to infants with severe birth defects (Source: “The Teratogenicity of Anticonvulsant Drugs”, New England Journal of Medicine, April 2001). In addition, the FDA has labeled Dilantin a pregnancy category D medication, which means there is positive human evidence regarding the potential for Dilantin to cause major birth defects among infants exposed to the drug in utero. Some of these birth defects are life-threatening and may require immediate medical treatment, sometimes followed by long-term medical care. In order to seek compensation for these injuries, medical expenses and pain and suffering, victims of birth defects can file a Dilantin lawsuit against pharmaceutical company, Pfizer, Inc.
Dilantin (phenytoin) is an anticonvulsant medication prescribed to individuals suffering from epilepsy and other seizure-related disorders. Dilantin was approved by the U.S. Food and Drug Administration in 1953 and, although it has been prescribed for a number of off-label uses like mood stabilization and anxiety control, its only approved use is to prevent tonic-clonic and complex partial seizures. Dilantin is currently manufactured by Pfizer. In 2008, the FDA added Dilantin to its “Potential Signs of Serious Risks” list, which means the FDA had identified a potential safety risk requiring further investigation (Source: “Dilantin Potential Signs of Serious Risks” 2008, fda.gov).
Some of the birth defects allegedly associated with Dilantin use during pregnancy include:
- Cleft lip
- Cleft palate
- Heart malformations
- Growth retardation
- Neural tube birth defects
- Mental retardation
- Fetal Hydantoin Syndrome
Cleft palate in particular causes a number of complications for an affected infant, including frequent ear infections, hearing loss, feeding difficulties, missing or misaligned teeth, and language and speech delay. The only way to repair a cleft palate and restore the function and appearance of the child's mouth is to perform reconstructive surgery. Even after this procedure, many affected children will require additional surgery or even long-term dental and orthodontic care in order to prevent further complications and to monitor the child's development.
According to FDA standards, pregnancy category D medications like Dilantin should only be prescribed to pregnant women if the possible benefits of the treatment justify the potential risks to the fetus. With the release of recent information concerning the potentially harmful nature of Dilantin use during pregnancy, and the presence of studies published in the past supporting this claim, women who took Dilantin during pregnancy and gave birth to infants with severe birth defects are advised to consult a Dilantin attorney to discuss their legal options. Not only do birth defects have a devastating physical effect on the child, but costly medical expenses can inflict a significant financial burden on the family as well. Only by filing a Dilantin lawsuit, can birth defect victims can receive the compensation they are entitled to in order to receive the medical care they require. For more information regarding Dilantin side effects, the birth defects allegedly associated with Dilantin, and the process of filing a Dilantin lawsuit, visit DilantinBirthInjury.com.