News from Lareb
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News from Lareb The Netherlands Pharmacovigilance Centre Lareb has received 30 reports of skin reactions associated with the use of oral iron salts (ferrous fumarate, ferrous gluconate, ferrous sulfate).* The reported reactions include pruritus, rash, hyperpigmentation, eczema and skin reactions following sun exposure. The latter reactions may be explained by either iron or a transferring iron complex acting as a photosensitiser. In addition, both Ferogradumet [ferrous sulfate] and Losferron [ferrous gluconate] tablets contain a synthetic azo dye that may elicit intolerance. While various skin reactions are reported in the literature, they are not listed in the Dutch Summary of Product Characteristics (SPCs) for the three oral iron salts. The WHO database contained 3668 ADR reports associated with oral ferrous salts. Angioedema, pruritus, urticaria and erythematous and maculopapular rashes were disproportionally associated with these products (reporting odds ratios of 1.4–1.7). * For details of 24 of these cases, see p16 this issue; 801052658, see Reactions 1210 p16; 801052659 and see Reactions 1210 p16-17; 801052660. Lareb. Oral iron salts and skin reactions. Internet Document : [4 pages], Jun 2008. 801052657 Available from: URL: http://www.lareb.nl
0114-9954/10/1210-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 12 Jul 2008 No. 1210
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