Adverse Reactions of Ferric Carboxymaltose

Thanusubramanian, Harish; Patil, Navin; Shenoy, Smita; Bairy, Laxminarayana Kurady; Sarma, Yashdeep Sinha

doi:10.7860/jcdr/2014/9499.5015

Cited by 3 publications

(2 citation statements)

References 7 publications

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“…Breathlessness and myalgia were also seen in the population who were involved in the clinical trial phases, but these adverse reaction were rare (<1%). [ 10 ]…”

Section: Discussionmentioning

confidence: 99%

Iron deficiency anemia with menorrhagia: Ferric carboxymaltose a safer alternative to blood transfusion

Mishra¹,

Verneker²,

Gandhi³

et al. 2018

J Mid-life Health

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Background:Menstrual disorder accounts for 5%–10% of the women presenting with iron deficiency anemia (IDA) in the perimenopausal age group. Heavy menstrual bleeding in this age group leads to severe anemia and frequently requires blood transfusion which has its own adverse effects. We today have ferric carboxymaltose (FCM) as a safer alternative to blood transfusion.Objective:The objective of the study is to evaluate the safety and efficacy of FCM in treating anemia in patients of menorrhagia. Thus avoiding blood transfusion.Materials and Methods:It was an open, single arm observational study including 90 women of age more than 30 years with definitive diagnosis of menorrhagia with IDA and hemoglobin (Hb) levels between 4 gm% and 11 gm%. Intravenous FCM (500–1500 mg) was administered, and the improvement in blood indices was assessed after 3 weeks of total dose infusion. Menorrhagia was controlled by medical treatment till Hb improvement was achieved and definitive surgical intervention was done.Result:Most of the women were in the age group of 40–50 years. Blood indices measured pre-FCM and 3 weeks post-FCM showed a mean increase in Hb from 8.33 ± 1.10 to 10.89 ± 1.02 with a statistically significant P < 0.01. There was a statistically significant rise of packed cell volume, serum ferritin, and serum iron in the post-FCM blood levels after 3 weeks. No serious life-threatening adverse events were observed after FCM administration.Conclusion:Intravenous FCM is an effective and a safe treatment option for IDA with a single administration of high dose without serious adverse effects obviating the need for blood transfusion before surgery.

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“…Breathlessness and myalgia were also seen in the population who were involved in the clinical trial phases, but these adverse reaction were rare (<1%). [ 10 ]…”

Section: Discussionmentioning

confidence: 99%

Iron deficiency anemia with menorrhagia: Ferric carboxymaltose a safer alternative to blood transfusion

Mishra¹,

Verneker²,

Gandhi³

et al. 2018

J Mid-life Health

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“…There are very few reports of hypersensitivity reactions with FCM as compared to ISC. Earliar Thanusubramanian et al [23] had reported a single case of hypersensitivity reaction with FCM after test dose whereas Sridhara et al [24] had reported delayed hypersensitivity with subsequent doses of FCM. Overall, FCM appeared to have relatively better tolerance with fewer side effects as compared to ISC.…”

Section: Discussionmentioning

confidence: 99%

Comparative Evaluation of Efficacy and Safety of Intravenous Ferric Carboxymaltose Versus Iron Sucrose Complex for the Treatment of Moderate Grade Anemia in Post Caesarean Section Women: A Randomized and Prospective Study

SAROJ

SHIRALEE

2023

Asian J Pharm Clin Res

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Objective: Iron deficiency anemia is common in postpartum women in India. The present study is aimed at comparing the safety and efficacy ofintravenous ferric carboxymaltose (FCM) with intravenous iron sucrose complex (ISC) in patients who underwent cesarean section and havingmoderate grade anemia in postpartum period.Methods: A prospective and comparative study was carried out in 100 post-cesarean section women with moderate grade anemia hemoglobin (Hb7–9 g%) in Gajra Raja Medical College, Gwalior (M.P.) from February 2019 to August 2020. Subjects were randomly allocated to two groups, namely,FCM and ICS, 50 patients in each group. In group FCM, patients were infused with 1000 mg of FCM in a single dose on 4th post-operative day. Patients inISC group were infused with ISC 200 mg in 100 mL normal saline on 3 alternate days on 4th, 6th, and 8th post-operative day. Mean, Hb mean corpuscularvolume (MCV), mean corpuscular Hb (MCH), and MCH concentration (MCHC) were recorded before start of therapy and 15 days after treatment in allstudy subjects. Mean reticulocyte count was recorded before start of treatment and 2 days after completion of treatment that is on 6th and 10th postcesarean day in FCM and ICS group, respectively. Adverse drug reactions were recorded during the study period. Statistical analysis was done usingStatistical Package for the Social Sciences software.Results: Mean Hb increased by 27% in FCM and by 19% in ISC group and is significant (*p<0.05) from baseline values. FCM showed significantly(**p<0.01) better response, than ISC group. Mean reticulocyte percent showed significant increase by 120% and 73% in FCM and ISC group,respectively, from the baseline and change in mean reticulocyte in FCM was significant (***p<0.001) as compared to ISC. The mean rise in MCV was12% and 5% and MCH was by 10% and 1% in FCM and ISC group, respectively. FCM groups showed significantly better response (p<0.05) than ISC.However, in MCHC, there were 7% and 4% increase in FCM and ISC group, respectively, and on inter group comparison was not significant (p>0.05).Adverse effects noted during the study were mild and responded to symptomatic treatment. Sixteen percentage of FCM cases and 26% of ISC casesunderwent adverse drug reactions that included nausea, vomiting, giddiness, and injection site reactions.Conclusion: FCM is more efficacious and safer than ISC, making it the first line of management in postpartum iron deficiency anemia.

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The Induction of Oxidative/Nitrosative Stress, Inflammation, and Apoptosis by a Ferric Carboxymaltose Copy Compared to Iron Sucrose in a Non-Clinical Model

Toblli

Cao

Angerosa

2015

JCDR

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Adverse Reactions of Ferric Carboxymaltose

Cited by 3 publications

References 7 publications

Iron deficiency anemia with menorrhagia: Ferric carboxymaltose a safer alternative to blood transfusion

Iron deficiency anemia with menorrhagia: Ferric carboxymaltose a safer alternative to blood transfusion

Comparative Evaluation of Efficacy and Safety of Intravenous Ferric Carboxymaltose Versus Iron Sucrose Complex for the Treatment of Moderate Grade Anemia in Post Caesarean Section Women: A Randomized and Prospective Study

The Induction of Oxidative/Nitrosative Stress, Inflammation, and Apoptosis by a Ferric Carboxymaltose Copy Compared to Iron Sucrose in a Non-Clinical Model

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