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🇵🇾 Paraguay /Health & Science

EMA reviews risk of bone problems linked to injectable iron treatments

From ABC Color · () Spanish

Translated from Spanish and summarized by DistantNews. Read the original for the full story.

At a glance

Newswire Official statement Under investigation
  • The European Medicines Agency has opened a review of injectable iron medicines over reports of low blood phosphate levels and related bone disorders.
  • The review follows serious cases, including patients who developed problems after only one or two doses without known risk factors.
  • The agency will assess all injectable iron medicines after concerns initially focused on ferric carboxymaltose.

The European Medicines Agency has opened a review of injectable iron treatments after receiving reports of serious cases involving low blood phosphate levels and bone damage, including among patients who received only one or two doses and had no known risk factors.

Serious cases even in patients treated with only one or two doses and without known risk factors.

· European Medicines AgencyThe agency cited these reports when announcing its review of injectable iron treatments.

The EMA’s Pharmacovigilance Risk Assessment Committee will examine the risk of hypophosphatemia, an abnormally low phosphate level in the blood, and related conditions such as osteomalacia. The disorder softens and weakens bones. If phosphate levels fall too far, osteomalacia can cause bone pain and, in some cases, fractures, the agency said.

Injectable iron medicines treat iron deficiency and iron-deficiency anemia when oral iron does not work well enough, cannot be used, or when patients need to restore their iron levels quickly. Hypophosphatemia and osteomalacia are already known adverse effects of medicines containing ferric carboxymaltose, a type of intravenous iron.

Cause fractures.

· European Medicines AgencyThe agency warned of a possible consequence of severe phosphate depletion and osteomalacia.

Hypophosphatemia is listed as a common side effect of ferric carboxymaltose, meaning it can affect up to one in 10 treated patients. The frequency of osteomalacia remains unknown. Current recommendations call for phosphate monitoring in patients receiving high doses or prolonged treatment, as well as those with known risk factors.

Frequent.

· European Medicines AgencyThe agency described hypophosphatemia as a common side effect of ferric carboxymaltose, affecting up to one in 10 patients.

The EMA said it launched the review after reports raised questions about whether those measures adequately protect patients. Some cases involved severe hypophosphatemia that progressed to osteomalacia after only one or two doses, even without recognized risk factors. The agency also identified delayed diagnoses, partly because fatigue, muscle pain and bone pain can resemble symptoms of the iron deficiency being treated. Osteomalacia may not always appear on X-rays, making diagnosis more difficult. Although the initial concerns centered on ferric carboxymaltose, similar cases have also been reported with other injectable iron medicines, prompting the committee to extend the assessment to all such products.

May not always be visible on X-rays.

· European Medicines AgencyThe agency highlighted a diagnostic difficulty associated with osteomalacia.
About this summary

Originally published by ABC Color in Spanish. Translated, summarized, and contextualized automatically by DistantNews, with a note on how the source frames the story. Not individually reviewed before publishing. How this works.

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