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Use of parenteral Iron-(III)-products in Germany
Parenteral iron (III) preparations are used since the 1950s for the treatment of iron deficiency, if oral iron preparations are not effective or cannot be used. Due to safety concerns due to occurrences of severe allergic reactions a risk the European Medicine Agencies’ (EMA) Committee for Medicinal Products for Human Use (CHMP) conducted a risk-benefit assessment between 2011 and 2013. The CHMP confirmed the positive risk-benefit assessment for parenteral iron (III) products, if certain risk minimization measures are adhered. This included that parenteral iron (III) preparation could only be administered if severe allergic reactions could be treated immediately. Moreover, it was recommended that pregnant women should only receive parenteral iron (III) products under exceptional circumstances, with special care to avoid administration in the first trimester. As the risk for severe allergic reactions can differ between different parenteral iron (III) products, the utilization of parenteral iron (III) preparations should be assessed in Germany based on data of the German Pharmacoepidemiological Research Database (GePaRD) in the general population and among pregnant women. The final report was submitted in Q4 2022. The results of the project will be published in 2023. The project is funded by the Federal Institute for Drugs and Medical Devices (BfArM).