The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2020 (PDF).
This month readers are advised that clozapine blood levels may need to be monitored more frequently in certain situations, for example if a patient starts or stops smoking, if taking concomitant medications that impact on blood levels or if pneumonia or another serious infection is present. Monitoring will usually be carried out by a specialist service.
Readers are also advised that denosumab 60mg (Prolia®), a treatment for osteoporosis, has been linked with an increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment. It is recommended that risk factors are assessed before starting treatment, particularly in those with a history of vertebral fracture. It is noted that the optimal duration of denosumab treatment for osteoporosis has not been established and it is recommended that patients should not stop denosumab without specialist review.
Readers are also made aware of an increased risk of diverticulitis seen in patients taking baricitinib (Olumiant®▼), particularly when concomitantly taking medicines associated with an increased risk of diverticulitis (non-steroidal anti-inflammatory drugs, corticosteroids and opioids). It is recommended that patients on baricitinib to seek immediate medical care if they experience severe abdominal pain especially accompanied with fever, nausea and vomiting or other symptoms of diverticulitis.
This update also contains links to resources that promote awareness of the risk of severe and fatal burns in emollient users. The resources raise awareness to avoid naked flames and heat sources that may act as a source of fire ignition.
The summary of letters to healthcare professionals includes information regarding handling errors that have been reported with leuprorelin-containing depot medicinal products, potentially resulting in lack of efficacy. The manufacturers stress that the instructions for reconstitution and administration in the product information must be followed.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.