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 piglets.

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 piglets, 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 Uniferon

Uniferon is a modern improved iron hydrogenated dextran based on a natural formula, which is approved for global use:

Uniferon is manufactured without the use of any organic solvents or cyanide, thus, avoiding trace residues of these impurities. Pharmacosmos manufactures iron dextran of high quality and unique purity for customers worldwide. Uniferon is the only injectable iron brand for piglets approved in the EU, the US and Asia.

About Pharmacosmos

Headquartered in Denmark, Pharmacosmos 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, its ongoing R&D programme focuses on improving the lives of patients with iron deficiency with or without anaemia. More than 1 billion people live with iron deficiency anaemia and it is the leading cause of death for an estimated 180,000 people every year. This makes it one of the largest global health challenges of our time.

Pharmacosmos has subsidiaries in the Nordics, the UK and the US and its products are marketed in more than 80 countries across the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA.