NPC Archive Item: May Drug Safety Update from MHRA/CHM

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17 May 2011

The MHRA and CHM have published the May edition of Drug Safety Update This issue gives safety advice on prasugrel▼ and lenalidomide▼ and highlights the withdrawal of Nicobrevin antismoking preparation from the UK market.

Drug Safety Update is an essential read for everyone whose professional practice involves medicines. It is published every month in electronic format only.

Prasugrel▼: rare but serious hypersensitivity reactions
Healthcare professionals should be aware of the potential risk of rare but serious hypersensitivity reactions with prasugrel and should monitor for signs in all patients, including those with a previous known history of hypersensitivity reactions to thienopyridines e.g. clopidogrel.  When prescribing prasugrel, prescribers should inform patients of the potential risk of hypersensitivity reactions, including angioedema. Suspected adverse reactions to prasugrel should be reported via the Yellow Card Scheme. More information is available in May DSU and in a letter for healthcare professionals.

Lenalidomide▼: investigation of risk of second primary malignancies in myeloma
Data from three large controlled clinical trials investigating use in patients with newly diagnosed multiple myeloma have recently shown a signal of an apparent excess of second primary malignancies in patients treated with lenalidomide. Use of lenalidomide in this or other unlicensed indications is not recommended and healthcare professionals should carefully consider the balance of risks and benefits of any off-label use. At present, there is no recommendation to delay, modify, or restrict the use of lenalidomide for the indication authorised in the EU; treatment of patients with multiple myeloma who have received at least one prior therapy. Current trials of lenalidomide as an experimental drug are under periodic safety monitoring, and the investigation of the signal for second primary malignancies does not affect enrolment or participation in these trials. Healthcare professionals should be vigilant for the occurrence of second primary malignancies, and should report such events promptly. More information is available in May DSU and in a letter for healthcare professionals.

Nicobrevin antismoking preparation withdrawn from the market
The CHM and its Pharmacovigilance Expert Advisory Group considered a review of the risks and benefits of Nicobrevin—a multi-ingredient antismoking preparation containing quinine, menthyl valerate, camphor, and eucalyptus oil. The CHM noted the lack of evidence for efficacy of Nicobrevin as an aid to smoking cessation and the association of quinine and camphor with adverse reactions. They advised that the risks of Nicobrevin outweigh any benefits, and use of an unproven antismoking preparation could delay or deter patients from seeking effective smoking-cessation treatments. Therefore, Nicobrevin has been withdrawn from the UK market. Various alternative antismoking treatments are available. More information on smoking cessation can be found in the NPC eLearning materials.

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