The antiepileptic drug topiramate has been the subject of a new FDA warning stating that the drug can cause cleft lip, cleft palate and cranial malformations in newborn babies. These extremely serious conditions can cause permanent damage and disability for a child, and families who have been harmed by topiramate have the right to seek compensation for their injuries.
Topiramate Birth Defects Update 7/19/12: A recently-published study, based on more than a decade’s worth of data, has confirmed prior research which identified a strong link between Ortho-McNeil’s controversial anti-convulsant Topamax (generic: topiramate) and oral cleft birth defects. This risk is greatest when expecting mothers take Topamax during their first trimester of pregnancy, a time when many women may still be unaware they are pregnant. Click here to learn more.
Free Topiramate Lawsuit Evaluation: If you or a loved one has given birth to a child with any of the defects listed in this article after taking topiramate in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
Topiramate (brand name Topamax®) is an FDA-approved anticonvulsant medication typically prescribed to treat certain types of seizures as well as to prevent migraine headaches. The drug is also commonly used with other medications to control seizures in people who have Lennox-Gastaut syndrome. Topiramate is thought to work by decreasing abnormal excitement in the brain.
Unfortunately, the U.S. Food & Drug Administration (FDA) has analyzed reports of a number of serious birth defects including cleft lip, cleft palate and cranial malformations related to topiramate. New data shows that expecting mothers who take the drug are over 20 times more likely to give birth to infants with an oral cleft defect compared to the risk in a background population of untreated women.
Due to increasing reports of these types of side effects, the FDA has required the topiramate label to be updated to include information about the birth defects risk. Additionally, topiramate has been placed in Pregnancy Category D. Medications in this category have been directly linked to birth defects in human studies.
Oral Cleft Defect Symptoms
Topiramate-induced cleft defects are usually identified shortly after birth and can include the following:
- change in nose shape
- failure to gain weight
- feeding problems
- flow of milk through nasal passages during feeding
- misaligned teeth
- poor growth
- recurrent ear infections
- separation of the palate
- speech difficulties
Additional Topiramate Resources
Do I have a Topiramate Lawsuit?
The Defective Drug & Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in topiramate lawsuits. We are handling individual litigation nationwide and currently accepting new cleft lip, cleft palate, and cranial malformation cases in all 50 states.
If you or a loved one has given birth to a child with any of the defects listed in this article after taking topiramate in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.