Recently Revised Topamax Label Includes Data Of 2014 Annual Report From The North American Antiepileptic Drug (NAAED) Pregnancy Registry
By means of an October 21, 2014 FDA letter to Janssen Pharmaceuticals, Inc. we first learned there was going to be a label change concerning Topamax and cleft lips in infants:
Revisions to Section 8.1 to describe the most recent data pertaining to the risk of oral clefts in infants exposed to topiramate during pregnancy, based on data from the 2014 Annual Report from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
Here is the revised Topamax (topiramate) Prescribing Information, updated October 2014 (accessed 11/20/14), with the above-referenced revision in section 8 USE IN SPECIFIC POPULATIONS, at 8.1 Pregnancy:
Data from the NAAED Pregnancy Registry (425 prospective topiramate monotherapy-exposed pregnancies) indicate an increased risk of oral clefts in infants exposed during the first trimester of pregnancy. The prevalence of oral clefts among topiramate-exposed infants was 1.2% compared to a prevalence of 0.39% for infants exposed to a reference [antiepileptic drug (AED)]. In infants of mothers without epilepsy or treatment with other AEDs, the prevalence was 0.12%. For comparison, the Centers for Disease Control and Prevention (CDC) reviewed available data on oral clefts in the United States and found a similar background rate of 0.17%.
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%.
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We have previously written about the risk of babies being born with cleft lips when their mothers used Topamax during their pregnancy, as seen below:
- Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects -- Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant [March 2011]
- FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases -- Request For Historical Incidence Data Made In Connection With NDA For New Obesity Drug [February 2011]
- Neurology Journal: Johnson & Johnson's Drug Topamax May Increase Risk of Birth Defects -- Beware If Taking This Seizure Medicine Alone Or With Other Epilepsy Drugs During Pregnancy [July 2008]
We will continue to monitor the safety profile of Topamax as regards children born to mothers who used this antiepileptic drug during their pregnancy.