Anemia that develops due to iron deficiency is called iron deficiency anemia. This common condition is treated with iron supplements taken either orally or given through an intravenous (IV) infusion. Ferric carboxymaltose (FCM) is one of the widely used, comparably newer IV iron preparations. Recently, several publications have raised the possibility that FCM may be associated with mild elevations in methemoglobin (metHb), a form of hemoglobin that cannot effectively deliver oxygen to tissues.
Methemoglobinemia is a known, though uncommon, side effect of some drugs. While usually mild and self-limiting, in certain cases it can become clinically significant or even life-threatening. This observational study is being conducted across multiple centers to better understand how often methemoglobinemia occurs after administration of FCM. As part of routine care, venous blood samples will be used to measure metHb levels in patients receiving FCM, and these results will be compared with those from individuals not exposed to the drug.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults (≥18 years)
✓. Presence of anemia (Hb \<12 g/dl in women, \<13 g/dl in men)
✓. Low ferritin (\<30 mcg/l)
✓. Patients for whom FCM administration has been decided in routine medical care practice
Exclusion criteria
✕. Known methemoglobinemia-related diseases (Hb M disease, cytochrome b5 reductase deficiency, etc.)
✕. Use of drugs associated with methemoglobinemia (acetylsalicylic acid, dapsone, chloroquine, metoclopramide, benzocaine, lidocaine, prilocaine, rasburicase, primaquine, sulfonamide, nitric oxide)
✕. Those with B12 and/or folate deficiency
✕. Those with Charlson Comorbidity Index ≥3
✕. Presence of advanced organ failure (Stage 4 and 5 chronic kidney disease, Child C cirrhosis, NYHA class 3 and 4 chronic heart failure, respiratory failure requiring oxygen supplementation and similar processes)
What they're measuring
1
Number of Participants with Treatment-Related Clinically Significant Methemoglobinemia
Timeframe: From the time of enrollment through 30 minutes following completion of the infusion. If methemoglobin level is ≥3% after infusion, blood sampling will continue every half hour after the last blood gas for 24 hours until methemoglobinemia is <3%.