Document Detail


Comparison of adverse event profile of Intravenous iron sucrose and iron sucrose similar in postpartumand gynecologic operative patients.
MedLine Citation:
PMID:  23252876     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Abstract Objective: Severe iron deficiency resulting in anemia is a common problem during pregnancy and in menstruating women. Several choices for IV iron replacement therapies exist and increased pressures on budgets may require cheaper 'iron sucrose similar' (ISS) to be used. In our practice, an iron sucrose similar (Ferex®; ISS(FRX)) was introduced to reduce costs in treatment of pregnant women or those planned for surgery. Post several months of use we observed increased rates of adverse events from patients and hence performed this analysis to confirm these findings. Methods: Data on adverse events was retrospectively collected from 658 patients treated between Sept 2004 and Dec 2011.Patients were analyzed in 3 cohorts, Iron Sucrose originator (IS(ORIG)), ISS(FRX) diluted in 100mL saline and ISS(FRX) diluted in 200mL saline. Results: The mean age was 38.5 years and included patients having normal delivery, Cesarean section, myomectomy, hysterectomy, cystectomy and adnexectomy. There were 169 patients in the IS(ORG) group and 210 and 279 in the ISS(FRX)-100 and ISS(FRX)-200 groups respectively. Adverse drug reactions were more frequent in the ISS(FRX) groups vs. IS(ORIG) (11.0% vs. 14.3% vs. 1.8%; p<0.02). Events were mild to moderate in nature and were predominately injection site reactions and phlebitis. Results may be impacted by imbalance in baseline characteristics and cumulative iron dose received, however events were mostly acute and all patients received 200mg iron as single administration. Conclusion: This is the first large analysis suggesting increased adverse events due to an ISS. For our practice, the use of ISS(FRX)was discontinued due to the safety concerns outweighing theoretical cost benefit. This study raises the question on the appropriate approval process for complex drugs and if these can be substituted without appropriate clinical testing, both for efficacy and most importantly safety, in routine clinical practice.
Authors:
Eun Sil Lee; Bo Ra Park; Jeong Sig Kim; Gyu Yeon Choi; Jeong Jae Lee; Im Soon Lee
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-20
Journal Detail:
Title:  Current medical research and opinion     Volume:  -     ISSN:  1473-4877     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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