The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2022 (PDF).
This issue advises clinicians that a new safety review of topiramate has been initiated. This is in response to the results of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy. Topiramate is already associated with an increased risk of congenital malformations and effects on fetal growth if used during pregnancy. Clinicians are advised to counsel patients who can become pregnant on the known and emerging risks of topiramate for an unborn baby and on the need to use effective contraception throughout use. It would be prudent to provide this counselling prior to commencing this medication and also at routine reviews.
This issue contains the latest COVID-19 vaccine and medicine information including product information updates for Vaxzevria®.
Lastly in this issue is a summary of letters to healthcare professionals in June. These generally related to supply issues and recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.