Authors Address Concerns with Elemental Impurities in Injectable Iron Study

[Editor's note: As a result of concerns expressed regarding the interpretation of the findings in the study entitled "Elemental impurities in injectable iron products for swine" published in the May/June issue of the Journal of Swine Health and Production, the study authors provided the following statement for inclusion in the AASV e-Letter.]

"In response to the recently published article "Elemental impurities in injectable iron products for swine" in the Journal of Swine Health and Production, concern has been raised regarding product and food safety. To clarify any misconceptions, the article does not state that any of the products available in the United States were or are considered unsafe for use in swine by any regulatory authority in the United States. The objective was to evaluate a number of different parenteral/injectable veterinary iron products for the presence of impurities with the hope that the findings would be used to potentially improve the already stringent quality production standards implemented by manufacturers. While the study clearly revealed new information concerning differences in the levels of detectable impurities (e.g., arsenic, chromium, and lead) amongst the injectable iron products evaluated, the quantities of such impurities (measured in micrograms per 200 mg dose of iron) need to be kept in context to their use as a one-time dose or two-half doses to a neonatal pig. Detection of these elements does not indicate that the products are unsafe and should not be used. All products available in the United States have maintained an adequate safety record according to FDA adverse event reporting records for the duration of their availability as FDA approved products. Thus, caution should be used in interpreting data from this publication to avoid over interpretation about the safety of injectable iron products. The data reported in the article is scientific in nature and should not be used to conclude that there is a food safety issue with pork or pork products.

Please do not hesitate to contact us directly with any further questions."

Steve Ensley
Kansas State University
Scott Radke
Iowa State University
Chris Olsen
Pharmacosmos Inc.