Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents

A review has found that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents (GdCAs).

Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected

Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.

Radium-223 dichloride (Xofigo▼): do not use in combination with abiraterone and prednisone/prednisolone, following clinical trial signal of increased risk of death and fractures

A European review has begun into the safety of radium-223 dichloride following an observed increase in the incidence of deaths and fractures in patients with chemotherapy-naive metastatic castration-resistant prostate cancer receiving radium-223 dichloride in combination with abiraterone acetate (Zytiga) and prednisone/prednisolone as part of a clinical trial.

Eluxadoline (Truberzi▼): risk of pancreatitis; do not use in patients who have undergone cholecystectomy or in those with biliary disorders

Cases of pancreatitis, with or without sphincter of Oddi spasm, have been reported in patients taking eluxadoline.

Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk

Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias.

Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections

Monitor patients closely for skin cancers.

Letters sent to healthcare professionals in November 2017

Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.

Medical Device Alert issued in November 2017

An alert was recently issued about Oxoid ceftazidime antimicrobial susceptibility test discs.

Posted on the UK MHRA website on 14 December 2017