Topamax (topiramate): Drug Safety Communication – During Pregnancy Linked to Oral Birth Defect Cleft Lip & Cleft Palate

Topamax During Pregnancy

Parents of children born with cleft palate or cleft lip need to know the drug Topamax has been linked to these birth defects. On March 4, 2011, the Federal Food and Drug Administration warned taking Topamax during pregnancy increases the chances a child will be born with cleft palate or cleft lip.

Topamax Manufacturers Failed to Warn of Topamax Link to Birth Defects

The drug Topomax (known generically as topiramate) is commonly prescribed to treat epilepsy and other seizure disorders, as well as severe migraines. But the drug’s manufacturer, Ortho-McNeil-Janssen, failed to warn physicians and pregnant women about the risks of oral birth defects. As a result, moms could not make an informed decision about other, less risky drugs to take during their pregnancies.

If your family has been impacted by the use of Topamax during pregnancy, and you would like to speak with a lawyer to discuss your situation, contact us for a free confidential consultation. Evening and weekend appointments are available at Pate & Spivey.

Cleft Palate and or Cleft Lip Lead to Painful Surgeries & Expensive Therapies

Babies born with cleft palate and cleft lip require numerous surgeries to correct their facial deformities. Until cleft palate is fully corrected, children often have severe difficulty eating, drinking and speaking. They often also have recurring ear infections and, possibly, hearing loss.

If your child was born with oral birth defects, you know pain and trauma involved in dealing with their deformities. In addition to the emotional toll on the families of babies with cleft lip, it also is extremely expensive to provide all of the medical care required, which can include:

  • Multiple surgeries of the lip and roof of the mouth
  • Plastic surgery
  • Speech therapy
  • Ear tubes and hearing therapy
  • Dental work
  • Orthodontics
  • Psychological assistance dealing with the emotional impact of a facial deformity

Did you take Topamax during pregnancy?

If you took Topamax and delivered a child with cleft lip (also known as harelip) or cleft palate, you may want to discuss your child’s injuries with a lawyer. It will be important to also discuss what can be done to help your family provide the necessary care your child may need. If a Topamax case were to result in money damages, those funds could help provide medical care for children with cleft lip or cleft palate.

Click here for more info about Topamax.


Initial consultations at Pate & Spivey are confidential and free. Evening and weekend appointments are available.

Posted in News, Pharmaceutical and Medical Device Litigation.