Drug Safety Update - December 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2022 (PDF).
This issue reminds clinicians about the ongoing Pregnancy Prevention Programme for Valproate medicines. Data show ongoing exposure to valproate in pregnancy and although use has declined, levels appear to have plateaued. As such, the Commission on Human Medicines (CHM) has advised new safety measures for valproate-containing medicines that are to be put in place in the coming months. For now, clinicians are reminded to follow the existing strict precautions, including:
- that valproate should not be prescribed to female children or women of childbearing potential unless other treatments are ineffective or not tolerated
- and that any use of valproate in women of childbearing potential who cannot be treated with other medicines is in accordance with the Pregnancy Prevention Programme
This issue contains the latest COVID-19 vaccine and medicine information including information on the authorisation of the Pfizer/BioNTech vaccine for use in infants and children aged 6 months to 4 years.
Lastly in this issue is a summary of letters to healthcare professionals in November. 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.
| « CKS Updates - November 2022 | SMC Update - December 2022 » |
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