The safety of intravenous iron preparations: systematic review and meta-analysis
The safety of intravenous iron preparations: systematic review and meta-analysis
Avni et al., 2015 | Mayo Clin Proc | Meta Analysis
Citation
Avni Tomer, Bieber Amir, ... Gafter-Gvili Anat. The safety of intravenous iron preparations: systematic review and meta-analysis. Mayo Clin Proc. 2015-Jan;90(1):12-23. doi:10.1016/j.mayocp.2014.10.007
Abstract
OBJECTIVE: To amass all available evidence regarding the safety of intravenous (IV) iron preparations to provide a true balance of efficacy and safety. METHODS: Systematic review and meta-analysis of all randomized clinical trials comparing IV iron to another comparator. All electronic databases until January 1, 2014, were reviewed. Primary outcome was occurrence of severe adverse events (SAEs). Secondary outcomes included all-cause mortality and other adverse events (AEs). Subgroup analysis was performed on the basis of type of IV iron, comparator, treated condition, and system involved. RESULTS: A total of 103 trials published between 1965 through 2013 were included. A total of 10,390 patients were treated with IV iron compared with 4044 patients treated with oral iron, 1329 with no iron, 3335 with placebo, and 155 with intramuscular iron. There was no increased risk of SAEs with IV iron (relative risk [RR], 1.04; 95% CI, 0.93-1.17; I(2)=9%). Subgroup analysis revealed a decreased rate of SAEs when IV iron was used to treat heart failure (RR, 0.45; 95% CI, 0.29-0.70; I(2)=0%). Severe infusion reactions were more common with IV iron (RR, 2.47; 95% CI, 1.43-4.28; I(2)=0%). There was no increased risk of infections with IV iron. Gastrointestinal AEs were reduced with IV iron. CONCLUSION: Intravenous iron therapy is not associated with an increased risk of SAEs or infections. Infusion reactions are more pronounced with IV iron.
Key Findings
A total of 103 trials published between 1965 through 2013 were included. A total of 10,390 patients were treated with IV iron compared with 4044 patients treated with oral iron, 1329 with no iron, 3335 with placebo, and 155 with intramuscular iron. There was no increased risk of SAEs with IV iron (relative risk [RR], 1.04; 95% CI, 0.93-1.17; I(2)=9%). Subgroup analysis revealed a decreased rate of SAEs when IV iron was used to treat heart failure (RR, 0.45; 95% CI, 0.29-0.70; I(2)=0%). Severe in
Outcomes Measured
- Requires manual extraction
Population
| Field | Value |
|---|---|
| Population | See abstract |
| Sample Size | 10390 |
| Age Range | See abstract |
| Condition | See abstract |
MeSH Terms
- Administration, Intravenous
- Anemia, Iron-Deficiency
- Drug-Related Side Effects and Adverse Reactions
- Humans
- Iron
- Outcome Assessment, Health Care
- Randomized Controlled Trials as Topic
Evidence Classification
- Level: Meta Analysis
- Publication Types: Journal Article, Meta-Analysis, Systematic Review
- Vertical: iron
Provenance
- PMID: 25572192
- DOI: 10.1016/j.mayocp.2014.10.007
- PMCID: Not in PMC
- Verified: 2026-04-09 via PubMed E-utilities API
Source extracted via PubMed E-utilities API on 2026-04-09