The popular prescription anticonvulsant and migraine medication Topamax has recently been linked to an increased risk of oral birth defects Oral birth defects, namely cleft lip and cleft palate, occur in the first trimester of pregnancy when the lip or palate fails to fuse properly. For pregnant women taking Topamax during the first trimester, the risk of their child developing a cleft lip or cleft palate is 20 times greater than women who are not taking the medication, read the Huffington Post article here.
Topamax is approved by the FDA for the treatment of seizures and migraine headaches; however, the drug is prescribed treat many other ailments through off-label prescriptions. Just last year Johnson & Johnson agreed to pay a $6.1 million fine for marketing Topamax for illegal marketing of Topamax.
As early as 2004, the FDA warned J&J its sales materials downplayed the "serious side effects associated with Topamax, including oligohidrosis (decreased sweating), hyperthermia, and metabolic acidosis," a violation of the Federal Food, Drug and Cosmetic Act. "These materials raise serious public health concerns because they encourage the unsafe use of Topamax, including, particularly, in pediatric patients," said FDA.
Again in 2008 the FDA warned that Topamax and other seizure medications should be closely monitored for increases in depression and potential mood changes that may result in an increase in suicidal thoughts or actions.
Women taking Topamax who plan to become pregnant should talk with their doctor about the potential birth defect risks associated with the use of Topamax. Since Topamax may often be taken by pregnant women who are not yet aware that they are pregnant, it is particularly important for women of child-bearing age to exercise great caution when taking Topamax.
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