The FDA has amended the label on Triferic (ferric pyrophosphate citrate) to alert clinicians that the anemia drug poses potential risks to pregnant and lactating women.

Triferic may cause fetal harm, according to the updated label. Women should use effective contraception to prevent pregnancy during treatment with Triferic and for at least 2 weeks afterward. 

Data on the risks for major birth defects and miscarriage in humans are still needed. In animal studies, ferric pyrophosphate citrate caused adverse developmental outcomes to the fetus and toxicity to the mother. In the general population, the estimated risk for major birth defects is 2 to 4% and miscarriage 15 to 20%.

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Whether Triferic presents in human milk is also unknown. According to the FDA, consider Triferic use during pregnancy or lactation only when benefits justify the potential risk to the fetus or infant.

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TRIFERIC (ferric pyrophosphate citrate) safety labeling changes approved By FDA Center for Drug Evaluation and Research (CDER). FDA; March 29, 2018.