A study comparing efficacy and safety of ferric carboxymaltose versus oral iron in postpartum women with anemia.

Background: Approximately 40 percent of pregnant women worldwide, according to the WHO, have anemia. Postpartum anemia is frequently observed. It normally accounts for 20 to 30 percent cases. However its frequency may be even high in women who had (30 % to 60%) third or fourth degree tears of vagina, removal of placenta manually and instrumental delivery. Oral medication is insufficient to treat PPA in moderate and severe cases. Parenteral treatment can prevent the requirement for blood transfusions throughout pregnancy and after delivery in these individuals and offers a better compliance. Aim: To compare efficacy and safety of ferric carboxymaltose versus oral iron in postpartum women with anemia Methods and Materials: In this study 162 pregnant woman were included. 12 were lost to follow up.8 were of oral iron group and 4 were of FCM group .Finally 150 women were followed. They were divided into two groups. Group A (oral iron group) included 75 patients .They were given 100 mg of iron tablets bid for 4 weeks. Group B (FCM group) included 75 patients. They were given 1000 mg of injection FCM.FCM was given by 1000 mg of injection in 250ml of normal saline over 15 minutes. Complete hemogram and serum ferritin were repeated after 2 weeks from the last dose of iron and injection of FCM. The adverse effects of drug administration in the two groups were also recorded Results: On comparing both the groups using independent t test we found that increase in Hb concentration and serum ferritin in FCM group is found to be statistically significant over oral iron group (p value .0001 and .0001).Our study also documented safety of FCM .There were minimal side effects of this drug and that too were minor ones as burning sensation over injection site, headache, itching etc. No major side effects were seen. Women in the two groups had comparable demographic profile. (P value >0.05).Mean post transfusion Hb in oral iron and FCM group was 9.81g/dl and 10.73g/dl respectively, which is statistically significant (p value =0.0001). Mean ferritin after treatment with oral iron and FCM was 149.35 and 208.90ng/dl respectively which is also statistically significant (p value=0.0001). Mean increase in Hb and serum ferritin in oral iron and FCM groups was 1.228, 2.63g% and 105.93 and 160.53ng/dl, respectively. Conclusion: Ferric carboxymaltose is very effective in correcting iron deficiency anemia among patients with postpartum anemia. The added benefits of FCM over oral iron included significant rapid correction of iron deficiency anemia, fast replenishment of iron stores with better patient compliance. [ABSTRACT FROM AUTHOR]