Leg amputation following intramuscular injection of iron dextran in a 32 year old woman
To inform healthcare professionals of a rare serious reaction leading to leg amputation following intramuscular injection of iron dextran and report comments for preventing such reactions.A case of leg amputation following intramuscular injection of iron dextran reported to Iranian Pharmacovigilance Center was reviewed. Patient and reaction data was collected by assessing the reported yellow card, patient chart review and interviewing with patient and physicians. World Health Organization definition for serious reactions was used to determine the seriousness of the reaction. Naranjo algorithm was used to determine probability scale. The probability of the reaction was determined based on questionnaire of Schumock et al. The studied case is classified as a rare and serious but preventable reaction induced by intramuscular injection of iron dextran in a 32 year old woman. The probability of the reaction is appeared to be “probable” based on Naranjo algorithm. It seems that Iron dextran could cause serious and life threatening adverse effects. It is necessary for healthcare professionals to be informed of such rare but serious reaction in order to apply preventive actions.
McEvory G. AHFS drug information. American Society of Health System Pharmacists, 2011.
Koda-Kimble MA, Young LY, Kradijan WA, Guglielmo JB, Allfredge BK, Corelli RL (eds). Applied Therapeutics, The Clinical Use of Drugs. Eight Edition 2005. Lippincott Williams and Wilkins: Maryland, USA 71-83.
Bielory L. Serum sickness from iron-dextran administration. Acta Haemotol 1990; 83(3):166-8.
Choulis NH, Dukes MNG. Metals. In: Dukes M.N.G., Aronson J.K. Meyler’s Side Effects of Drugs. 14th ed. Amsterdam, PA: Elsevier Science B.V.; 2000:700.
Lin P, Goldberg L, Phillips T. Calciphylaxis. Available from: URL: http//www.medscape.com/viewarticle/438054_print.
Calciphylaxis. Available from: URL: http://www.mayoclinic.org/ calciphylaxis.
Nunley JR. Calciphylxis. Available from: URL:http://www.emedicine.com/ derm/topic555.htm
Bailie GR, Clark JA, Lane CE, Lane PL. Hypersensitivity reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant 2005; 20 (7): 1443-9.
Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant 2006; 21 (2): 378-82.
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992; 27: 538.
Naranjo CA, Busto U, Sellers EM. A method for estimating the probability of adverse drug reactions. Clin Pharmacother 1981; 30: 239-45.
Dexferrum (iron dextran injection)-Labeling Change. Available from: URL: www.fda.gov/safety/MedWatch/SafetyInformation.