MHRA Drug Safety Update
August 2019
Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus
Establish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab.
https://www.gov.uk/drug-safety-update/daratumumab-darzalex-risk-of-reactivation-of-hepatitis-b-virus
Naltrexone/bupropion (Mysimba▼): risk of adverse reactions that could affect ability to drive
Advise patients that naltrexone/bupropion has been associated with adverse reactions such as dizziness or somnolence, which can affect ability to drive, operate machinery, or perform dangerous tasks.
https://www.gov.uk/drug-safety-update/naltrexone-bupropion-mysimba-risk-of-adverse-reactions-that-could-affect-ability-to-drive
Carfilzomib (Kyprolis▼): reminder of risk of potentially fatal cardiac events
Anti-cancer therapy with carfilzomib has been associated with cases of cardiac arrest, cardiac failure, and myocardial infarction, including in patients without pre-existing cardiac disorders.
https://www.gov.uk/drug-safety-update/carfilzomib-kyprolis-reminder-of-risk-of-potentially-fatal-cardiac-events
Letters and drug alerts sent to healthcare professionals in July 2019
Letters were sent about Oncaspar▼ (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium).
https://www.gov.uk/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-july-2019
Medical Devices Alerts issued in July 2019
Alerts were issued about Telefunken automated external defibrillators and BD Microtainer capillary blood specimen collection tubes.
https://www.gov.uk/drug-safety-update/medical-devices-alerts-issued-in-july-2019
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