Cleft Palate - Consumer Justice Foundation

Cleft Palate

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Dilantin and Cleft Palate

Dilantin is an anticonvulsant medication manufactured by Pfizer, Inc., which was originally approved by the FDA in 1953. 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. Since its introduction to the U.S. market, Dilantin has been prescribed to individuals suffering from epileptic seizures, particularly grand mal or complex partial seizures, and seizures occurring during or after neurosurgery. In some instances, Dilantin may be an appropriate treatment for off-label purposes including mood stabilization and anxiety control.

Although Dilantin has become one of the first choices in epilepsy and seizure treatment, there are significant concerns regarding the drug’s potential to cause birth defects among infants exposed to the drug during pregnancy. In fact, in 2008, the FDA added Dilantin to its “Potential Signs of Serious Risks” list, which means the agency had identified a potential safety risk requiring further investigation. The allegedly harmful nature of Dilantin and other anticonvulsant drugs has been illustrated by credible medical studies which indicate that women who take Dilantin while pregnant may increase their risk of giving birth to infants with one or more serious birth defects, including cleft palate.

Cleft Palate Signs and Symptoms

Cleft palate is a craniofacial birth defect which occurs during the early stages of fetal development and is present at birth. This defect is characterized by an opening in the palate, or roof of the mouth, caused by a lack of cells in the area when the structure was formed in utero. A cleft palate can affect the bony front portion of the mouth or the soft back portion of the mouth and can range from a small hole at the back of the mouth to a severe crevice in the roof of the mouth. Children born with a cleft palate typically struggle with a number of complications resulting from the defect, including:

  • Frequent ear infections
  • Hearing loss
  • Feeding difficulties
  • Missing or misaligned teeth
  • Language and speech delay
  • Cleft Palate Treatment and Prognosis

There are temporary treatment options available for infants born with a cleft palate, including the use of specially-designed baby bottles and/or a man-made palate which may allow the child to eat properly. However, the only way to permanently correct a cleft palate and restore the appearance and function of the palate is for the child to undergo reconstructive surgery. In some cases, the child may require multiple surgeries, followed by long-term dental and orthodontic care in order to promote normal development of the child’s oral structures and to prevent further complications.

Dilantin and Birth Defects

According to a study published in 2001 in the New England Journal of Medicine, 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 over a seven-year period, and divided them into separate groups based upon anticonvulsant exposure during pregnancy. Among the women who used only one anticonvulsant while pregnant, 87 took phenytoin (Dilantin), 58 took carbamazepine (Tegretol), and six took valproic acid (Depakote), among other drugs. According to researchers, the major birth defects observed in this study included cleft palate, cleft lip, spina bifida, hypoplasia of the midface, hypoplasia of the fingers, growth retardation, microcephaly (defect of the skull), limb defects, heart defects, anal atresia (missing or misplaced opening to the anus) and hypospadias (genital defect in male infants). One or more of these defects were present among 20.6% of infants exposed to one anticonvulsant drug, 28% of infants exposed to two or more, and only 8.5% of infants exposed to no anticonvulsant drugs.

Dilantin Use While Pregnant

Dilantin has been placed into the FDA’s pregnancy category D because of positive human evidence which shows the drug may cause significant harm to a fetus when taken during pregnancy. If you are currently pregnant or planning to become pregnant and you are taking Dilantin, consult your physician immediately to discuss alternative treatment options. It may be dangerous to suddenly discontinue use of a prescription medication without medical consent. However, with your doctor’s help, you may be able to find a safer way to treat your medical condition.

A Dilantin Attorney Can Help

Infants born with cleft palate may require multiple surgeries to correct the defect, followed by long term medical care in order to encourage proper development and prevent any further complications. Unfortunately, this extensive medical treatment may result in costly medical expenses that may be an overwhelming burden to an affected family. If you or a loved one has suffered from a cleft palate and you believe the anticonvulsant drug Dilantin to be the cause, contact a Dilantin attorney to discuss the benefits of filing a Dilantin lawsuit against Pfizer. The goal of Dilantin lawsuits and potential Dilantin class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and pain and suffering endured by you and your family.

Consumers expect their prescription medications to treat their medical conditions without causing them any unreasonable harm. Unfortunately, there are some drugs currently on the market which have potential fetal risks which may actually outweigh the possible benefits of the drug. It is the responsibility of drug manufacturing companies to manufacture safe medications and to alert the public of any adverse side effects associated with their drugs. However, some pharmaceutical companies intentionally conceal the hazardous nature of their medications in order to avoid negative consequences, such as a drug recall. This puts consumers at risk of suffering debilitating injury, illness and death just by taking their prescription medications. The only way to protect your rights and collect the compensation you deserve is to hire a Dilantin lawyer to represent your case.

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