Fatal anaphylactic reaction due to ferric carboxymaltose: A case report

Iron-deficiency anemia is most frequently related with insufficient nutrition. However, it is also encountered in chronic diseases including chronic renal failure (CRF) and congestive heart failure (CHF). Oral or intravenous (IV) iron replacement is recommended for its treatment (1, 2). IV administration is the preferred route in CRF and CHF, where intestinal mucosal edema and diminished gastrointestinal blood flow limit absorption of oral iron. Although IV route may cause hypersensitivity reaction (HSR), it is generally safe. The report of the European Medicines Agency declares that IV-iron treatment has a high benefit/risk ratio (3). Ferric carboxymaltose (FCM) is a nondextran third-generation IV-iron preparation which has the advantage of normalizing hemoglobin and replenishing iron stores over a short period of time because it can be administered fast and in high doses (4). It has been approved and presented to the market in 2007 in Europe and in 2012 in Turkey (5). Clinical research has shown that it is generally well tolerated and has low serious HSR risk (≥1/10.000 to <1/1.000) (1, 4, 6, 7). Evaluation of safety reports discloses that there are four cases of death related to FCM (5, 8). To our knowledge, this is the first case of death related to FCM in Turkey and the fifth case of fatal anaphylactic reaction (AR) in the literature.