June 22, 2018
Heavy metal impurities found in 94 percent of tested injectable irons for piglets
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)1, indicate that arsenic, chromium and lead can inadvertently be administered with iron injections to piglets, depending on the product used.
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 JSHAP1 peer-reviewed, open-scientific literature article mentioned above.
In the recent JSHAP1 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 JSHAP1 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
[1] Radke SL et al. Elemental impurities in injectable iron products for swine. J Swine Health Prod. 2018;26(3):142-145
Piglets are very susceptible to iron deficiency anaemia. Iron deficiency anaemia among piglets poses a risk to both animal welfare and productivity. An injection of iron shortly after birth is an effective and globally established way to prevent this.
Heavy metal impurities may arise from several sources: They may be residual impurities of raw material components, or catalysts that were intentionally added during drug synthesis, or they may become impurities via contamination by processing equipment or container/closure systems.
Because heavy metal impurities do not provide any therapeutic benefit, their levels in the drug product should be controlled within acceptable limits, in accordance with the European Medicines Agency (EMA) states in its ICH guideline Q3D on elemental impurities in human medicines.
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 US, China, UK, Ireland, Germany, Sweden and Norway and its products are marketed in more than 80 countries around the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA.
