The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2011 (PDF).
This issue contains drug safety information advising clinicians that clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have shown a four-fold increased risk of second primary malignancy. The risk appears to be lower in patients treated for relapsed or refractory myeloma. Use of lenalidomide in newly diagnosed multiple myeloma is currently unlicensed and therefore not recommended except as part of a clinical trial. It is advised that clinicians should consider the possibility of possibility of second malignancy in patients treated with lenalidomide.
The yellow card scheme section highlights the value of spontaneous post-marketing surveillance by describing how yellow card reports received in the first year following the launch of rosuvastatin helped to identify a higher than expected rate of rhabdomyolysis with the 40mg dose. A review of the reports led to updating prescribing advice that protected public health.
The stop press section contains a reminder that dosing recommendations for paracetamol in children have been updated. Products are now entering the market with the revised dosing instructions.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
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