By the Numbers
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Helping You Live Better
Product Warning
The FDA cautions women of childbearing age about the dangers of topiramate , a popular migraine medication .
For years , topiramate , an anticonvulsant drug better known by the brand name Topamax , has been one of the most popular prescription medications for the treatment of migraine . But if you are pregnant or planning to become pregnant , it might be time to ask your doctor for another option . The U . S . Food and Drug Administration ( FDA ) recently informed the public of new data that suggest an increased risk for cleft lip and / or cleft palate in infants born to women who are treated with topiramate during pregnancy . Research by the North American Antiepileptic Drug Pregnancy Registry at Massachusetts General Hospital showed that the prevalence of oral cleft birth defects among infants exposed to topiramate during the first trimester of pregnancy was 20 times that of infants whose mothers received no anticonvulsant treatment during pregnancy .
The FDA approved topiramate for the treatment of epileptic seizures in 1996 and for the treatment of migraines in 2004 . But based on this new data , both the FDA and the Consumer Justice Foundation , a for-profit agency dedicated to consumer advocacy , now recommend expectant mothers talk to their physicians about alternatives to topiramate for migraine treatment .
“ Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age ,” agrees Russell Katz , MD , director of the division of neurology products in the FDA ’ s Center for Drug Evaluation and Research . “ Alternative medications that have a lower risk of birth defects should be considered .”
Cleft lip and cleft palate are congenital birth defects that occur when the tissue that forms the upper lip and roof of the mouth do not join before birth . This can lead to problems with eating , speaking and hearing . Most birth defects occur during the first trimester of pregnancy , when the fetus is most vulnerable and many women do not know they are pregnant .
This is not the first time topiramate has been linked to birth defects . A 2008 study , published in the journal Neurology , also cautioned consumers about the popular drug . Product labels for Topamax and its generic equivalents already carry a warning about the risk of birth defects associated with the medication , but the labels will now use stronger language about positive evidence of fetal risk based on “ human data .”
By the Numbers
32.3 million
The number of topiramate prescriptions dispensed at outpatient retail pharmacies in the U . S . from January 2007 through December 2010 .
12 HEAD WISE | Volume 1 , Issue 3 • 2011