Recently Revised Topamax Label Includes Data Of 2014 Annual Report From The North American Antiepileptic Drug (NAAED) Pregnancy Registry
SUMMARY: Here is part of the revised Topamax Prescribing Information (updated October 2014) as regards the increased risk of oral clefts in infants exposed during the first trimester of pregnancy:
The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 9.6 (95% Confidence Interval [CI] 4.0 – 23.0) as compared to the risk in a background population of untreated women. The UK Epilepsy and Pregnancy Register reported a similarly increased prevalence of oral clefts of 3.2% among infants exposed to topiramate monotherapy. The observed rate of oral clefts was 16 times higher than the background rate in the UK, which is approximately 0.2%.
We will continue to monitor the safety profile of Topamax as regards children born to mothers who used this antiepileptic drug during their pregnancy.[Read this article in full at original source]
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