The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2015 (PDF).
Clinicians are advised that there have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib (Xalkori®). Most cases occurred within a month of starting treatment and affected patients with or without pre-existing heart disorders. It is recommended that all treated patients are monitored for signs and symptoms of heart failure (including dyspnoea, oedema, or rapid weight gain from fluid retention).
Clinicians are also notified of the risk of potentiation of radiation toxicity with vemurafenib (Zelboraf®) when given before, during, or after radiotherapy. This is unlikely to impact upon primary care.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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