The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2019 (PDF).
This issue advises that febuxostat should be avoided, unless no other therapy options are appropriate, in patients with pre-existing major cardiovascular disease due to an increased risks observed in a clinical trial. The study (CARES) found a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to febuxostat than in those assigned to allopurinol.
This issue also advises that tocilizumab (RoActemra®) has been linked with rare risk of serious liver injury including cases requiring transplantation. It is recommended that alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter. Some areas may arrange monitoring under shared care.
There is also a reminder that rivaroxaban (Xarelto®) 15 mg and 20 mg tablets should be taken with food. There have been reports of reduced efficacy when taken on an empty stomach. The lower strengths can be taken with or without food.
Finally this month, the summary of letters to healthcare professionals includes a letter regarding the risk of teratogenicity and neuropsychiatric disorders with retinoids and the pregnancy prevention programme launched last month. There is also a link to a letter regarding the febuxostat advice mentioned above.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.