JNJ - EU regulators warn pregnant women not to use topiramate
2023-09-01 10:47:51 ET
The European Medicines Agency’s safety committee has recommended that pregnant women avoid using products containing topiramate due to concerns that it may cause neurodevelopmental disorders in children exposed to the drug while in the womb.
Topiramate is approved in the US and EU to treat epilepsy and migraines. It’s also used to treat weight loss when combined with phentermine. Drugs that contain topiramate include Johnson & Johnson’s ( NYSE: JNJ ) Topamax, Supernus’s ( NASDAQ: SUPN ) Trokendi, and Vivus’s Qsymia. The drug is also marketed under the names Qudexy and Topiragen.
The EMA panel advised people using the drug for weight loss or migraines not to use the product if they are pregnant or use effective birth control if they can get pregnant. The agency also advised pregnant women who use the drug to treat epilepsy not to use it unless there is no other suitable treatment available.
The drug already carries a warning in the US that use during pregnancy could result in a higher risk of babies being born smaller or with cleft lip/palate. The EMA noted in a statement Friday that the drug had already been linked to “serious” birth defects when used during pregnancy.
The EMA safety panel recommendations come after a review of three observational studies, two of which indicated that children of women who took the drug during pregnancy had a higher risk of neurodevelopmental disorders such as autism spectrum disorder, intellectual disability and ADHD.
The recommendations will now be forwarded to the Coordination Group for Mutual Recognition and Decentralized Procedures-Human. Once the group issues an opinion, new guidelines for the drug will be disseminated to healthcare professionals by the EU market authorization holders.
More on Topiramate:
For further details see:
EU regulators warn pregnant women not to use topiramate