Iron-deficiency anemia: A reminder of what to look for as new oral treatment approved for adults

Health Canada recently the green light for the marketing of Accrufer (iron maltol) for the treatment of adults with iron-deficiency anemia. According to the company that distributes it in Canada, Kye Pharmaceuticals, this is the “only prescription-only oral treatment option indicated for the treatment of iron deficiency and iron deficiency anemia in Canada.”Accrufer is indicated for adults with iron-deficiency anemia “who are unresponsive or intolerant to other oral iron preparations.” Available in 30 mg tablets to be swallowed, its recommended dosage is 30 mg twice a day, morning and evening, on an empty stomach. The duration of treatment depends on the severity of the iron deficiency, but in general a prescription of at least 12 weeks is required, and treatment can be continued for as long as necessary to replenish the body's iron stores, says the Canadian product monograph.ContraindicationsFerric maltol is contraindicated in patients with active inflammatory bowel disease as there is a potential risk of increased inflammation, and also in those with hemochromatosis and other iron overload syndromes, or who receive repeated blood transfusions.Unlike other oral iron treatments, Accrufer does not contain ferrous iron (Fe2+). Instead, it is composed of stable ferric iron (Fe3+) bound to a natural sugar derivative, maltol. It “offers improved tolerability (because) the maltol protects the iron as it passes through the stomach, thus reducing gastrointestinal side-effects,” says the Kye Pharmaceuticals press release.The most frequently reported side-effects were gastrointestinal symptoms, including: flatulence (4.6%), diarrhea (4%), constipation (4%), stool discoloration (4%) and abdominal pain (2.9%). These adverse events were mainly of mild to moderate severity. The proportion of patients who discontinued treatment due to adverse events in the double-blind, placebo-controlled study was 2.5%.Key symptomsIron deficiency anemia is the most common form of anemia. According to the Canadian Health Measures Survey, an estimated 6.1% of the population suffers from iron deficiency, with women more affected (8.3%)—particularly during pregnancy—than men (4%). Its main symptoms are fatigue, pale skin, brittle nails, food cravings, difficulty concentrating, low blood pressure, etc.A person is considered iron-deficient when the serum ferritin level is below 15 μg/L for adults and 12 μg/L for children. Iron deficiency anemia may be due to insufficient iron intake through the diet; to an iron malabsorption disorder caused by a condition affecting the digestive mucosa, such as Crohn’s disease or celiac disease; or to digestive bleeding or hemorrhagic menstruation. Over the long term, it can lead to a deterioration in quality of life and a reduced immune response. In pregnant women, it can lead to complications for the unborn child (low birth weight, premature delivery, etc.).Manufactured by the Shield Therapeutics laboratory, ferric maltol has been approved in the United States since 2019 under the same trade name as in Canada (Accrufer). It was also approved in 2019 by the European Medicines Agency, but under the name Ferracru.

Iron-deficiency anemia: A reminder of what to look for as new oral treatment approved for adults

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