Drug Safety Update - April 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2023 (PDF).
This issue gives advance notice that new safety measures will be introduced in the coming months to strengthen the safety of isotretinoin treatment. These new measures include:
- addition of new warnings for the risk of sexual dysfunction, including the possibility of persistence after treatment discontinuation
- development of consistent monitoring requirements for potential psychiatric and sexual side effects in all patients throughout treatment
- initiation of treatment in patients younger than 18 years will require two prescribers to agree a patient’s acne is severe and that there is no other effective treatment
It is recommended that prescribers to fully discuss the risks with patients considering isotretinoin.
This issue also introduces new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality in patients using Janus kinase (JAK) inhibitors. It is recommended that JAK inhibitors are avoided where alternatives exist in patients age 65 years and over, current or past long-time smoking and anyone with risk factors for cardiovascular disease or malignancy. Caution is also advised in patients with additional risk factors for VTE. And due to an increased risk of non-melanoma skin cancer associated with tofacitinib, periodic skin examinations are now advised.
Additionally, this issue contains a reminder to be vigilant for pulmonary and hepatic adverse drug reactions associated with use of nitrofurantoin. Patients and caregivers should be advised to be vigilant for, and report, any new or worsening respiratory symptoms. This can occure with short and long term use of nitrofurantoin. If such symptoms occur, the nitrofurantoin must be stopped immediately. Clinicians are also advised to periodically monitor for changes in biochemical tests that would indicate hepatitis or liver injury, especially in patients using nitrofurantoin for longer durations.
Lastly in this issue is a summary of letters to healthcare professionals in March. These generally related to supply issues and recalls. Of particular note, a letter noted continued intermittent shortages of Ozempic▼, which are expected to continue throughout 2023.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.