On March 4, 2011, the Food and Drug Administration (“FDA”) issued a warning that Topiramate, a seizure, epilepsy and migraine medication marketed as Topamax, increases the risk of oral birth defects including cleft lip and/or cleft palate.
The FDA approved Topiramate to prevent migraine headaches (but not to relieve migraine headache pain) and it has been used “off-label” to treat other conditions.
Topamax has been on the market since 1996 and was the 13th best selling prescription drug in 2008 with $2.4 billion pm annual U.S. sales.
Although previously classified as a “Pregnancy Category C” drug (meaning that animal studies data suggested potential fetal risks) because new human data shows an increased oral cleft risk, Topiramate was placed in “Pregnancy Category D” signifying human fetal risk.
Specifically, data indicates that if Topiramate is taken during pregnancy there is a higher risk that the baby will develop a cleft lip and/or cleft palate.
Cleft lip and cleft palate range from a small notch in the lip to a groove running into the roof of the mouth and nose, possibly leading to eating, talking and ear infection problems.
Oral clefts happen early in pregnancy, before many women even know they are pregnant, and surgery is used to close the lip and palate.
Topiramate’s benefits and risks should be carefully weighed when prescribing to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.
Further, because suddenly stopping Topiramate can cause serious problems, Topiramate should not be stopped before talking to a healthcare professional, even in pregnant women.