Topamax® links 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 took Topamax® while pregnant, you might qualify for compensation. .
As an anti-seizure medication, Topamax® (generic name: topiramate) is for the treatment of Lennox-Gastaut syndrome (which causes seizures) and for convulsions. It is also prescribed off-label for:
In fact, Ortho-McNeil, the drug’s maker, was fined over $6 million in 2010 by the FDA for promoting off-label uses of this drug.
In March 2011 the FDA warned physicians that Topamax® treatment during pregnancy increases the risk of cleft lip and cleft palate. The FDA changed the Pregnancy Category of Topamax® to Category “D,” at the same time. This indicated significant risk to babies.
Children can be born with one or both of these conditions. A cleft lip can be a small notch in the upper lip, or a complete bilateral cleft lip. A cleft palate is a condition where the palate does not close properly.
Most 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 can experience:
If you or your child has injuries because of a dangerous drug, contact The Law Offices of L. Clayton Burgess today!