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Lenalidomide MHRA safety warning and SPC updated

15th February 2011

Lenalidomide (Revlimid, Celgene) is authorised in combination with dexamethasone for treatment of multiple myeloma in patients who have received at least one previous treatment. Section 4.2 of the UK SPC for lenalidomide has been updated to include the sentence "Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient."

Evidence from clinical trials and case reports suggest that lenalidomide may further increase the elevated risk of both venous and arterial thromboembolic reactions, including myocardial infarction and cerebrovascular accident, in patients with myeloma. Additional information has been added to section 4.4 under cardiovascular disorders, regarding this and section 4.8 has been amended to include adverse reactions from post marketing data.

For more details see the MHRA drug safety update and the SPC from the links below.

Revlimid SPC
MHRA drug safety update

NPSA publishes risk assessment guide for venous thromboembolism

15th February 2011

The UK National Patient Safety Agency (NPSA) has published a ‘How to’ guide to support NHS organisations in the implementation of venous thromboembolism risk assessment for all patients admitted to hospital. It builds on existing resources already available on this topic and can be used to support the implementation of NICE Quality Standards Programme, CQUIN requirements and NICE Guideline 92.

NPSA How to guide
NICE clinical guideline CG92

Update: thalidomide monograph

9th February 2011

The thalidomide monograph has been fully updated and has been published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review. This version supersedes the PCF3 (first print, 2007) and the website version (dated June, 2008).

Prommer E et al (2011) Therapeutic Reviews: Thalidomide. Journal of Pain and Symptom Management. 41: 140-145.

This is the 4th therapeutic review in a series in the JPSM. Previous updated monographs include octreotide (July 2010), propofol (September 2010) and psychostimulants (November 2010). The updated octreotide monograph was the top article downloaded from the JPSM website in 2010.

Look out for more updated monographs in the therapeutic reviews section in the coming months e.g. ketamine.

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