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OPDP Warns Michigan Drugmaker for Product Claims, Missing Warnings

December 10, 2019

The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Rockwell Medical of Wixom, Michigan over its web page for Triferic (ferric pyrophosphate citrate), an iron-replacement for adults with hemodialysis-dependent chronic kidney disease.

The promotional web page made false or misleading claims about the product’s efficacy and it failed to mention the limitations of use, the OPDP said.

The website falsely implied that Triferic is safer and more effective than other intravenous iron replacements, the office said, noting that Triferic is the only approved iron-replacement product administered by dialysis, but the drug works the same as other approved products once it enters the bloodstream.

Rockwell Medical claimed that the drug “improves the effectiveness of iron delivery for the majority of dialysis patients,” but did not note that the FDA-approved indication did not include patients receiving dialysis through the abdomen, and that Triferic “has not been studied in patients receiving at-home dialysis.”

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