The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2017 (PDF).
This issue contains updated information about the risk of developmental disorders seen in babies born to mothers who take valproate medicines. It is estimated that there is a 30–40% risk of developmental disability and a 10% risk of birth defects. Despite previous communications there is evidence that women are still not aware of the risk. The following new recommendations are therefore being made:
- Do not prescribe valproate medicines for epilepsy or bipolar disorder in women and girls unless other treatments are ineffective or not tolerated; migraine is not a licensed indication
- Ensure women and girls taking valproate medicines understand the 30–40% risk of neurodevelopmental disorders and 10% risk of birth defects and are using effective contraception
- Valproate use in women and girls of childbearing potential must be initiated and supervised by specialists in the treatment of epilepsy or bipolar disorder
There is also a summary of letters sent to healthcare professionals in March including a letter noting the reintroduction of a paediatric carbocisteine liquid that is double the strength of the same presentation discontinued in January 2015. Clinicians should ensure an appropriate dose volume is prescribed when using this product.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.