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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Stronger Topamax Label Warning – Too Little? Too Late?

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The revelation of data has lead to a stronger Topamax label warning. Now the pharmaceutical product is considered a Pregnancy Category D drug, which means that there is substantial evidence of human fetal risks. Now the public is finally aware of that data — and it raises the question for doctors and their patients — do the benefits of Topamax outweigh the dangers in some cases.

But is this warning too little? Is it too late? Certainly for children now suffering from oral clefts of the lip or palate, it is too late to have prevented their injury. And if the mother was taking the drug, not for seizures, but simply to prevent migraine headaches, was it necessary to subject the infants to the risk and outcome of these birth defects?

A cleft lip, cleft palate, takes place when portions of the lip or palate do not fully connect together during the first trimester of a woman’s pregnancy. These birth defects also may cause a small notch in the lip or a groove along the roof of the mouth and nose. Since this happens in the first 3 months of pregnancy, it is particularly problematic since women may not yet know they are pregnant while they continue to ingest Topamax. Oral palate injuries lead to eating and talking problems, can result in some developmental delays, and can result in ear infections.