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FDA Warns of Topamax Cleft Lip and Topamax Cleft Palate Birth Injury Risk

On March 4, 2011, the U.S. Food and Drug Administration, FDA, notified healthcare professionals and the public of an increased risk for the development of cleft lip and cleft palate in infants whose mothers received Topamax treatment with while pregnant.

According to the FDA, data from the North American Antiepileptic Drug Pregnancy Registry reflect an “increased risk of an oral cleft in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4% prevalence of oral clefts, compared with a prevalence of 0.38% – 0.55% in infants exposed to other antiepileptic drugs. Infants born to mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07%.”

Based on this information, the FDA has reclassified Topamax as a “Pregnancy Category D” medication. Pregnancy Category D indicates that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but that in certain situations, the use of the drug in pregnant women may be warranted, despite the potential risks. The FDA will require a Topamax labeling change to alert patients and healthcare providers of the increased risk of cleft lip and cleft palate associated with Topamax therapy.

Why is Topamax (topiramate) Prescribed?

Topamax (topiramate) is an anticonvulsant medication prescribed alone or in combination with other drugs to treat epilepsy patients with certain types of seizures. It is also used to prevent migraine headaches in patients, but not to treat migraine pain. Topiramate is marketed under the brand names Topamax and Topiragen.

Cleft Lip and Cleft Palate

Cleft lip and cleft palate occur when two sides of the upper lip or palate fail to join together before birth. Cleft lip and cleft palate occur early in fetal development, during the first trimester of pregnancy. According the National Institutes of Health, NIH, a cleft lip may range from a notch in the lip to an opening that runs through the lip and into the nose. With cleft palate, both the front and/or back parts of the palate may fail to close resulting in an open groove in the roof of the mouth. Surgery is required to repair both conditions.

Complications Associated with Cleft Lip and Cleft Palate

Some of the complications and difficulties associated with a cleft lip or palate include:

  • Feeding problems
  • Failure to gain weight
  • Frequent ear infections and hearing loss
  • Dental problems, including misaligned teeth and cavities
  • Speech difficulties
  • Emotional stress

Repair of Cleft Lip and Cleft Palate

Depending on the severity, an oral cleft repair may require multiple surgeries. In the case of a cleft lip, surgery is usually performed within the infant’s first year; sometimes as early as 6 weeks of age. A second surgery may be required later in life if the nose area is also affected.

Cleft palate surgery is usually performed between six months and 18 months of age. Multiple surgeries may be required to completely close the palate; and additional surgeries may be required during adolescence or early adulthood to address the lip, upper jaw, nose, and positioning of the teeth.

Additional Medical Care Associated with Oral Clefts

The medical services and costs of care for oral cleft management will vary from patient to patient. An individualized plan addressing each child’s needs should be created and implemented by a team of health care professionals, shortly after birth. Referred to as a “cleft team,” this group of specialists will work with the family and child for as long a necessary, often through adolescence and young adulthood. The cleft team may consist of surgical and dental specialists, a speech therapist, otolaryngologist, audiologist, nurse, coordinator, and social worker, etc.

Obtain a Free Topamax Lawsuit Case Evaluation

If your child has suffered birth defect that may be due to a medication that you had taken during pregnancy, and you would like a free lawsuit evaluation, please call The Weinberg Law Firm toll free at 1-877-934-6274.

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