Topamax Birth Defect Lawsuit
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Have you or someone you love taken Topamax® while pregnant, and then given birth to an infant with cleft lip or palate, or both? If so, you are probably eligible to file a Topamax® birth defect lawsuit. Topamax® (topiramate) has been shown to cause oral clefts in humans, according to data reviewed by the U.S. Food and Drug Administration (FDA).
To contact a Topamax® birth defect attorney, please contact us today.
Topamax®-Oral Cleft Link
Topamax® is a medication prescribed to reduce the frequency of certain types of seizures in epileptics. It also is prescribed to prevent migraines, but has not been shown to reduce the pain of migraines once they have begun.
On March 4, 2011, the FDA published an announcement for patients and healthcare professionals to warn of a link between taking Topamax® during the early weeks of pregnancy and the chances of having a child born with oral clefts. According to data collected by the North American Antiepileptic Drug Pregnancy registry, oral clefts occur more frequently in babies that are exposed to Topamax® than those exposed to other medications.
Data gathered by a pregnancy registry in the United Kingdom, the UK Epilepsy and Pregnancy Register showed a 3.2 percent risk of developing oral clefts in babies exposed to Topamax. This equaled a 16-fiold increase in risk compared to the general population.
Because of the data indicating a link between Topamax® and babies born with oral clefts, the FDA changed the pregnancy category of the medication from Pregnancy Category C, meaning Topamax® caused birth defects in laboratory animals, to Pregnancy Category D, meaning the drug has been shown to cause birth defects in humans.
Cleft Lip and/or Palate
Cleft lip and palate can be as small as a small notch in the upper lip. In larger clefts, the separation can be a groove that leads into the roof of the mouth and nose. The larger clefts can cause problems with:
- Eating
- Speaking
- Language delays
- Repeated ear infections
- Breathing
- Hearing loss
- Dental problems
Surgery, often multiple operations, is the primary way to treat oral clefts. These children often also need to be treated by speech pathologists, otolaryngologists, dentists, orthodontists and psychologists.
How to File a Topamax® Lawsuit
If you and your baby have been through the pain and suffering of dealing with oral clefts, you should consider filing a Topamax® birth defect lawsuit. A qualified attorney can help you and your baby get the compensation you are entitled to.
