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Safety updates
Lenalidomide investigation of risk of second primary cancers in myeloma
Data from three large controlled clinical trials investigating the use of lenalidomide in patients with newly diagnosed multiple myeloma have suggested an apparent excess of second primary cancers. On the basis of this observation, a review of the balance of benefits and risks of lenalidomide is being undertaken in the European Union (EU). The UK Medicines and Healthcare products Regulatory Agency (MHRA) have stated that the use of lenalidomide for newly diagnosed multiple myeloma or other unlicensed indications (unless part of a current trial) is not recommended. Health professionals should be vigilant for the occurrence of second primary cancers when using lenalidomide in its authorised indication, and report such events promptly.
Thalidomide increases risk of arterial thrombosis
The UK MHRA have highlighted that patients treated with thalidomide have an increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events, in addition to the established risk of venous thromboembolism. Health professionals should consider venous and arterial thrombotic risk and administer antithrombotic prophylaxis for at least the first …
Footnotes
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Competing interests None.
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Provenance and peer review Commissioned; internally peer reviewed.