Important Birth Defect Information: Topamax® has been linked to an increase in the risk for cleft lip and cleft palate in babies whose mothers take the drug during their pregnancies. If your baby is born with a birth defect such as cleft lip or cleft palate and you were prescribed Topamax® while pregnant, you might qualify for compensation. .
As an anti-seizure medication, Topamax® (generic name: topiramate) is FDA-approved for the treatment of Lennox-Gastaut syndrome (which causes seizures) and for convulsions. It is also prescribed off-label for:
- migraine headaches
- bipolar disorder
- obesity (e.g., binge eating, bulimia)
- cocaine addiction
- tobacco (cigarettes) addiction
- post-traumatic stress disorder
- neuropathic pain
In fact, the maker of Topamax®, Ortho-McNeil, was fined over $6 million in 2010 by the FDA for promoting off-label uses of Topamax®.
Is Topamax® Linked to Cleft Lip and Palate?
The FDA warned physicians in March 2011 that Topamax® treatment during pregnancy increases the risk of cleft lip and cleft palate. At the same time, the FDA changed the Pregnancy Category of Topamax® to Category “D,” which indicated thatthere is significant evidence of risk to human fetuses from this drug.
Cleft Lip and Cleft Palate
A cleft lip may manifest as a small notch in the upper lip, or it may be a severe, complete bilateral cleft lip. A cleft palate refers to a condition in which the palate does not close properly. Children can be born with one or both.
Most oral clefts can be repaired, but it is not always possible to repair the cleft without leaving a scar or mark. Children with these birth defects face a number of complications, including:
- difficulties eating
- ear infections and hearing loss
- problems with their teeth
- problems with speech
- psychological challenges
Don’t Delay! Call Clay!
Mothers and fathers of a baby with a birth defect can turn to us for help. We are familiar with drug-related birth defects and the stress they can cause a family. We work hard to find out why these defects occur and fight to get the maximum amount of compensation possible so the children can receive the best in medical care. Don’t delay! Call Clay! Our initial consultation is FREE! Our experienced staff members are here to help.