Sept 4 (Reuters) – A European drug safety committee on Friday launched a review of injectable iron medicines over concerns they may cause low phosphate levels and bone problems, including softening of the bones.
Injectable iron-containing medicines are used to treat iron deficiency and iron-deficiency anaemia when oral iron does not work well enough, cannot be used, or when iron levels need to be restored quickly, the EMA’s safety committee said.
Here are some details:
• The European Medicines Agency said its review was initiated after reports about the effectiveness of the current measures to reduce this risk for medicines containing the active substance ferric carboxymaltose.
• The reports included serious cases of low blood phosphate levels and bone softening in people who had received only one or two doses of the active substance, the regulator said.
• The committee said it will evaluate whether the risks affect the overall risk-benefit balance of the injections and if any changes are warranted to their marketing authorisations.
• Earlier this week, the U.S. Food and Drug Administration added a boxed warning to ferric carboxymaltose injection labels about the risk of low phosphate levels.
• The EMA’s review covers all injectable iron-containing medicines after similar cases were reported with products beyond those containing ferric carboxymaltose.
• The review excludes oral iron medicines, which provide considerably lower amounts of iron over time and are considered less likely to cause low blood phosphate levels or hypophosphataemia, the EMA said.
(Reporting by Ankita Bora in Bengaluru; Editing by Shreya Biswas)
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