The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2020 (PDF).
This month clinicians are invited to report suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) to the MHRA via the Yellow Card Scheme. More than 2,600 cases of lung injury have been reported to the US Centers for Disease Control and Prevention (CDC) with 60 fatal cases. Clinicians should have a high index of suspicion in patients presenting with respiratory symptoms where there is a history of e-cigarette use or vaping in the past 30 days.
Clinicians are also notified of a small increased risk of oral clefts following use of ondansetron in the first 12 weeks of pregnancy. This information comes from epidemiological studies in the USA which have some limitations but are sufficiently robust to indicate an increased risk. Ondansetron is not usually used as a first line treatment in hyperemesis gravidarum. Where it is offered, women must be counselled on the potential benefits and risks of use, both to her and to her unborn baby and the final decision should be made jointly.
The summary of letters to healthcare professionals this month includes a further group of letters recalling ranitidine, a letter advising that three presentations of Insuman® are being discontinued and an update on the valproate Pregnancy Prevention Programme.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.