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Drug Safety Update - May 2011

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2011 (PDF).

This issue contains drug safety information advising clinicians of rare reports of serious hypersensitivity reactions noted with prasugrel (Efient®). These reactions have included cases of angioedema; some of which occurred in patients with a history of hypersensitivity to clopidogrel. Patients are advised to immediately report symptoms suggesting hypersensitivity (e.g. swelling of the face, neck, tongue, lips, or throat; rash; itching or shortness of breath) and clinicians are asked to report such reactions through the yellow card scheme.

This issue also reports that the smoking cessation product Nicobrevin® has been withdrawn from the market. A review of the benefits and risks noted a lack of evidence for efficacy and the association of quinine and camphor with adverse reactions. The product license has been cancelled and distribution has ceased.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.