Heavy metal impurities found in 94 percent of tested injectable irons

June 22, 2018

New data show unexpected and measurable concentrations of arsenic, chromium and/or lead  in 15 of 16 widely distributed injectable iron products for use in baby pigs.

The data, which were published in the academic Journal of Swine Health and Production (JSHAP) [i], indicate that arsenic, chromium and lead can inadvertently be administered with iron injections to baby pigs, depending on the product used.

Only one product was found to have non-detectable levels of arsenic and lead

The analysis was carried out by an FDA-certified independent contractor testing laboratory and the Iowa State University Veterinary Diagnostic Lab, which is one of the leading universities laboratories utilized for assay of veterinary medicine products. In 15 products,  unexpected and measurable concentrations of the heavy metals arsenic, chromium and  lead  were reported by the two above referenced testing laboratories. Only one product - Uniferon - had non-detectable levels of both arsenic and lead. Uniferon was also the only product where chromium levels  were far below the levels of concern to the authors of the JSHAP [i] peer-reviewed, open-scientific literature article mentioned above.

Manufacturing process affects the purity

In the recent JSHAP [i] article, the authors state that adherence to high standards of manufacturing is paramount to creating an injectable veterinary iron product that is safe, efficacious and consistent.

"As the new study shows, iron is not just iron. Even products with the same generic name can differ in their respective levels of heavy metal impurities. The purity of the product depends on the particular processing steps employed to avoid and remove impurities introduced during the manufacturing process. Uniferon is the only brand of injectable iron for the global veterinary market that meets both veterinary and human manufacturing standards," says Dr. Lars Christensen, President and CEO of Pharmacosmos.

"At Pharmacosmos, we are committed to quality. This means that we seek complete control of every step in the manufacturing process. It also means that we always strive to produce products of the highest quality, whether they are for human or for veterinary use. The JSHAP [i] publication is a testament to the hard work of our employees and the expertise that we have accumulated through 50 years of focus on the treatment of iron deficiency anemia" adds Dr. Christensen.

To read the full publication follow this link: https://www.aasv.org/shap/issues/v26n3/v26n3p142.html

[i] Radke SL et al. Elemental impurities in injectable iron products for swine. J Swine Health Prod. 2018;26(3):142-145

About Injectable Iron

Baby pigs are very susceptible to iron deficiency anemia. Therefore, iron deficiency anemia in litters of baby pigs poses a risk to both animal health, welfare, and productivity. An injection of iron shortly after farrowing is an effective and is a globally established "best practices method" utilized to prevent iron deficiency anemia in baby pigs.

About Uniferon 200

Uniferon 200 is a modern and much improved iron hydrogenated dextran, based upon a very low impurity profile formulation, whereby this source of injectable iron for baby pigs has been approved by numerous healthcare authorities for global use.

Pharmacosmos manufactures iron dextran of high quality and unique purity, which is distributed to human and animal drug customers worldwide. Uniferon 200 is the only injectable iron brand for baby pigs approved by healthcare authorities in the EU, in the U.S. and in Asia.

About Pharmacosmos

Pharmacosmos Inc, located in Watchung, NJ as a fully owned subsidiary of Pharmacosmos A/S. is dedicated to the sales of veterinary pharmaceuticals for the treatment and prevention of iron deficiency Anemia, including Uniferon 200.

Headquartered in Holbaek, Denmark, Pharmacosmos A/S is a family-owned, international healthcare company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use.

A research-based company, the Pharmacosmos A/S ongoing R&D program focuses on improving the lives of patients with sub-clinical and full-scale iron deficiency anemia. More than 1 billion people live with iron deficiency anemia and it is the leading cause of death for an estimated 180,000 people world-wide every year. This makes sub-clinical and full-scale iron deficiency anemia one of the largest global health challenges of the current time.

Pharmacosmos A/S has subsidiaries in the US, China, Nordics, Germany, UK and Ireland, and its products are marketed in more than 80 countries around the world. The Pharmacosmos A/S manufacturing facilities located in Denmark have supported global healthcare authority approvals, among others, by the Danish Medicines Agency and the U.S. FDA.