There has been an increased concern over the use of Topamax – a treatment for migraine headaches and for epilepsy – during pregnancy has been associated with an increased risk of birth defects. There have been reports of birth defects like cleft palates, cleft lips, genital defects.
Besides the anecdotal reports, the respected medical journal Neurology published an article—albeit with a small cohort—that found that women who used Topamax to prevent seizures associated with epilepsy had a much higher incidence of delivering babies with birth defects.
While the study included only 203 pregnancies (178 children), the data found that women who used Topamax while pregnant had babies born with cleft lips or palates 11 times more frequently than you would otherwise expect. These children had genital defects at a rate 14 times higher than would be expected. Of the 178 babies, 16 had major birth defects.
This is an unfortunate development for Topamax, a drug that is apparently efficacious in treating the migraines that are debilitating for so many. A study published last year in Lancet found that patients using Topamax—which was approved for migraine headaches in 2006 – had a reduction in the number of migraine days per month and reported significant quality of life improvements.
It is also worth noting that the label for Topamax indicates its association with birth defects, miscarriages, and decreased fetal weight in rabbits, rats, and mice.
Our lawyers are not taking Topamax cases at this time. One study of this size—absent other facts—does not give rise to a lawsuit. But our lawyers will closely monitor the reports and literature on birth defects in children whose mothers were using Topamax during pregnancy.
If you would like to ask our lawyers about a question regarding Topamax, or would like to be included on information as it develops with Topamax, call 800-553-8082.