The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2019 (PDF).
This issue warns that yellow fever vaccine (Stamaril®) must not be given to anyone who is immunosuppressed and extreme caution needs to be used people aged 60 years and older due an increased risk of life-threatening reactions. This follows two recent reports of fatal adverse reactions with suspected yellow fever vaccine-associated viscerotropic disease (YEL-AVD) shortly after administration of the vaccine.
This issue also advises that the Annual Risk Acknowledgement Form, which should be used during annual specialist review of all women and girls of childbearing potential on valproate medicines, has been updated. The updated form dated March 2019 should be used in future reviews.
Readers are reminded that pregabalin (Lyrica®) and gabapentin (Neurontin®) were rescheduled as controlled drugs with effect from the start of this month. It is recommended that healthcare professionals evaluate patients carefully for a history of drug abuse before prescribing pregabalin and gabapentin and observe patients for development of signs of abuse and dependence.
Finally this month, the summary of letters to healthcare professionals includes a letter advising of the new restrictions and precautions for use of fluoroquinolone antibiotics as covered in Drug Safety Update last month.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.