Risk of hypophosphataemia with ferric carboxymaltose
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Risk of hypophosphataemia with ferric carboxymaltose In a recent Drug Safety Update, the MHRA advised healthcare professionals about the risk of symptomatic hypophosphataemia in patients treated with ferric carboxymaltose [Ferinject], which may rarely lead to osteomalacia or fractures. Patients with iron deficiency may be treated with ferric carboxymaltose if oral iron preparations are ineffective/ unusable and when rapid iron delivery is required. In a recent European review, it was concluded that ferric carboxymaltose is associated with hypophosphataemia osteomalacia, and recommended awareness by healthcare professionals to ensure early detection and management. Hypophosphataemia is a known adverse event of ferric derisomaltose (iron isomaltoside; [Monofer]). Although the worldwide exposure to ferric derisomaltose was 3216 000 patient-years at February 2020, and cases of hypophosphataemia have been reported including two in the UK, there had not been any reports of hypophosphataemic osteomalacia. At February 2020, the worldwide exposure to ferric carboxymaltose was 12 491 000 patient-years. There had been 36 reports of hypophosphataemia, including 30 moderate to severe cases (83%), with a median time to onset of 14.5 months. This included 28 cases of osteomalacia, 6 cases of hypophosphataemic osteomalacia, and 2 cases reporting both. Of these cases, there have been 28 reports of hypophosphataemia and 2 cases of hypophosphataemic osteomalacia in the UK. Thirteen patients had received 1000mg per infusion, for an average of 19 infusions over 5–24 months. All cases had at least one risk factor for osteomalacia. Fractures occurred in 19 patients (53%), comprising femoral neck, pelvis or hip fractures. Patients received phosphate, calcium and/or vitamin D supplements, and surgery if required. The MHRA notes that there may be a higher risk of hypophosphataemia and osteomalacia in patients treated with ferric carboxymaltose rather than other IV iron formulations. Serum phosphate levels should be monitored, especially in those with pre-existing risk factors treated with multiple administrations at high doses. All adverse reactions should be reported to the agency, and patients should be advised to seek medical advice if they develop symptoms. Medicines and Healthcare products Regulatory Agency. Ferric carboxymaltose (Ferinject): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures. Drug Safety Update : 16 Nov 2020. Available from: URL: https://www.gov.uk/drug-safety-update/ferric-carboxymaltose-ferinject-risk-of-symptomatic-hypophosphataemia803518023 leading-to-osteomalacia-and-fractures
0114-9954/20/1832-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
Reactions 28 Nov 2020 No. 1832
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