Topamax® Lawsuit Help
The Law Firm of Eric H. Weinberg is currently assisting the families of children who were born with a cleft lip or cleft palate as a result Topamax® exposure. We are ready to help you. If you believe that your child has suffered a birth defect as a result of Topamax®, and you have a question concerning your legal rights, please select Free Topamax® Lawsuit Evaluation, or contact us toll free at 1-877-934-6274. We pledge to bring our more than 25 years of experience litigating pharmaceutical lawsuits to bear on your behalf.
FDA Warns of Topamax® Cleft Lip and Topamax® Cleft Palate 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 treatment with Topamax® 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 of 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 Evaluation
The Law Firm of Eric H. Weinberg has represented hundreds of individuals and thousands more class action claimants injured by the side effects of well known prescription drugs including Vioxx, Ortho Evra, Depakote, Accutane, Baycol, and blood clotting products. If your child has suffered an oral cleft or other birth defect that may be linked to Topamax® or Topiragen® use, and you would like a free lawsuit evaluation, please select Topamax® Lawsuit/Topamax® Lawyer Evaluation Form, or call us toll free at 1-877-934-6274.