The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2020 (PDF).
This month clinicians are advised that the licence for ingenol mebutate gel (Picato®) has been suspended as precautionary measure due to risk of skin malignancy. The European Medicines Agency (EMA) continues to investigate these concerns.
This issue also advises of the distribution last month of updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the conditions of the pregnancy prevention programme are met.
The insertion site and method for etonogestrel (Nexplanon®) contraceptive implants has been amended to avoid this risk of deep insertion. This is following concerns regarding reports of neurovascular injury and implants migrating to the vasculature.
Readers are also encouraged to support ADR awareness week between 17–23 February 2020 by sharing material on social media and discussing with colleagues and patients the importance of reporting suspected side effects.
The summary of letters to healthcare professionals includes this month includes links to letters warning of the risks of congenital malformation with modafinil and potentially fatal dosing errors with methotrexate as well as letters regarding some of the items above. The medical device letters highlights a risk of stoma injury, bleeding and leakage under the skin barrier with specific batches of convex two-piece skin barriers that have been incorrectly manufactured with off-centre starter/stoma hole. Identification and return of affected devices is recommended.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.