Reactions 1269 - 12 Sep 2009

★ SAmfepramone

First report of necrotising vasculitis: case reportA 52-year-old woman developed necrotising vasculitis

after taking a ‘Mexican herbal medicine’ containingamfepramone and an unidentified compound for weightloss.

The woman began taking the herbal medicine, whichwas labelled as containing several herbs andhydrochlorothiazide, twice daily [dosage not clearly stated].After 4 weeks, she developed flu-like symptoms of varyingintensity for 1 week; she took one pill of ibuprofen duringthis time and her symptoms spontaneously resolved. Onemonth later, she developed pruritus on her hands, feet andtrunk. Dark red, painful, palpable skin lesions, severalcentimetres in diameter, and central necrosis appearedsymmetrically on both legs.

The weight-loss supplement was stopped. A skin biopsyrevealed leucocytoclastic vasculitis and fibrinoid necrosisof the vessels, fibrin thrombi in the capillaries and venulesand immunocomplex deposits of fibrinogen, C3 andimmunoglobulin (IgM) in the vessel walls. The womanstarted receiving methylprednisolone and herhaemorrhagic necrotising vasculitis gradually resolved overseveral weeks. The supplement was subsequently analysedand each tablet was found to contain 69mg ofamfepramone and minor amounts of an unidentifiedcompound with an amine structure and a molecular weightof about 384, but no hydrochlorothiazide and no herbalingredients apart from starch.

Author comment: "We consider amfepramone to be theprobable cause (Naranjo scale: 5 points) of the necrotisingvasculitis in this patient . . . However, we cannot exclude thepossibility that the unidentified compound with aminestructure may have caused this adverse drug reaction".Halbsguth U, et al. Necrotising vasculitis of the skin associated with an herbalmedicine containing amfepramone. European Journal of Clinical Pharmacology 65:647-648, No. 6, Jun 2009 - Switzerland 801150467

» Editorial comment: A search of AdisBase, Medline andEmbase did not reveal any previous case reports ofnecrotising vasculitis associated with amfepramone. TheWHO ADR database contained one report of necrotisingvasculitis associated with amfepramone.

1

Reactions 12 Sep 2009 No. 12690114-9954/10/1269-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved