We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topiramate is known to be associated with an increased risk of congenital malformations and effects on fetal growth if used during pregnancy. Continue 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.
Information about a review into the safety of topiramate, which will look at possible harms in the learning and development of children whose mothers took topiramate during pregnancy.
A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary.
We remind healthcare professionals that elderly patients are at an increased risk of adverse neurological and cardiac effects when being treated with haloperidol for delirium. The lowest possible dose of haloperidol should be used for the shortest possible time, and cardiac and extrapyramidal adverse effects should be closely monitored.