☀️     🌓

Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - April 2017

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.

Share 'Drug Safety Update - April 2017' by emailShare 'Drug Safety Update - April 2017' on FacebookShare 'Drug Safety Update - April 2017' on TwitterShare 'Drug Safety Update - April 2017' on LinkedInShare 'Drug Safety Update - April 2017' on reddit


One Comment to “Drug Safety Update - April 2017”

  1. […] In the summary of letters sent to healthcare professionals in July it is noted that further information has been sent to doctors and pharmacists about the use of valproate medicines in girls, women of childbearing potential and women who are pregnant or planning pregnancy. This information supports the advice issued in the Drug Safety Update in April 2017. […]

    Pingback by Drug Safety Update - August 2017 - Prescribing Advice for GPs — August 15, 2017 #

Leave a Reply to Drug Safety Update - August 2017 - Prescribing Advice for GPs Cancel reply

Your email address will not be published. Required fields are marked *

Please be aware that you comment is subject to our Privacy Policy.

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Prescribing Advice for GPs is powered by ClassicPress.
Connect to our RSS or Atom Feeds.