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Drugs & Medical Devices

FDA Took Years To Process Topamax Birth Defect Data

— March 12, 2011

It wasn’t until March of 2011 that the FDA issued a warning that linked Topamax with cleft palate and cleft lip birth defects.  But back in July of 2008, a study linked the drug to those very defects:

For the study, researchers examined women who became pregnant while taking topiramate either on its own or along with other epilepsy drugs. Of 178 babies born, 16 had major birth defects. Three of these were in infants whose mothers were taking only topiramate, and 13 were in those whose mothers were taking topiramate and other epilepsy drugs.

Four of the babies had cleft palates or cleft lips, a rate 11 times higher than that expected if these women were not taking epilepsy drugs. Four male babies had genital birth defects, with two of those classified as major defects, which is 14 times higher than the normal rate for this defect.

Source: Epilepsy Drug May Increase Risk of Birth Defects

It’s unfortunate that our regulatory system can take years to recognize the risks that drugs cause to unborn children.  At least the risk is recognized now, and hopefully there will not be as many women who take Topamax while pregnant.


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