TOPAMAX (Topiramate) use in pregnant women has now been linked to an increased risk of neuro-developmental disorders and birth defects in children whose mothers were taking topiramate during pregnancy.
The increased risk of neuro-developmental disorders, including autism spectrum disorder and intellectual disability, was identified in a large observational study.
Janssen-Cilag, the sponsor for Topamax (topiramate) products, is updating the Topamax data sheet and issuing a Dear Healthcare Professional Letter (see HERE)with information relating to this safety update.
The Topiramate data sheets already included information about the risk of congenital malformations.
Read up on the study on neuro-developmental disorders HERE.
The above article was sent to subscribers in Pharmacy Daily's issue from 13 Apr 23
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 13 Apr 23
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