Heavy metal impurities found in 94 percent of tested injectable irons

May 7, 2018

New data show concentrations of arsenic, chromium and/or lead exceeding the permitted daily exposure limit for humans in 15 of 16 widely used injectable iron products for piglets.

The data show that arsenic, chromium and lead can inadvertently be administered with iron injections to pigs depending on the product used. In addition, the data which were published in the academic Journal of Swine Health and Production (JSHAP)1, showed that only one product was free of elevated levels of all three heavy metal impurities.

"These substances should be avoided in the pork production chain and it is up to the pig producers to make sure that arsenic, chromium and lead are not injected into piglets," says leading expert in swine health Professor Jens Peter Nielsen, DVM, Ph.D., Dipl. ECPHM, Nutrition and Health, University of Copenhagen, Denmark.

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, one of the leading universities for veterinary medicine. In 15 products, the concentration of the heavy metals arsenic, chromium and/or lead exceeded the FDA and EMA permitted daily exposure limit for humans. Only one product - Uniferon - had non-detectable levels of both arsenic and lead. Uniferon was also the only product where chromium levels did not exceed human permitted daily exposure limits.

Experts agree that heavy metals like arsenic and lead are recognized risk factors for human cardiovascular disease and have been associated with peripheral arterial disease, electrocardiographic abnormalities and left-ventricular hypertrophy. 2, 3, 4

Risk even at low levels of exposure

The results add to a growing pool of data on the role of environmental threats to human health. A recent study by Bruce P. Lanphear and colleagues, published in The Lancet Public Health 5, demonstrated that low-level lead exposure is an important and largely overlooked risk factor for death, particularly for cardiovascular disease deaths. In fact, the study showed that even blood lead concentrations lower than 5 μg/dL (<0,24 μmol/L) are associated with all-cause mortality, cardiovascular disease mortality, and ischemic heart disease mortality. In an expert comment in The Lancet 6, international public health expert Dr. Philip J. Landrigan noted an especially striking and unexpected finding whereby the association between lead and disease is proportionately greater at lower levels of exposure-a so-called supralinear dose-response relation.

"Considering recent evidence which demonstrates how low levels of exposure, especially to lead and arsenic, can have negative effects on human health, toxic heavy metals should not be knowingly injected into food production animals," says Professor Steve Ensley, DVM, MS, Ph.D., who is a veterinary toxicologist from the Iowa State University Veterinary Diagnostic Laboratory, Vet Diagnostic & Production Animal Medicine, and the senior author of the publication in JSHAP.

Manufacturing process affects the purity

In the recent JSHAP 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. Human pharmaceutical drugs are subject to strict standards to avoid impurities.7

"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 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 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 anaemia" adds Dr. Christensen.

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

Contact information

Mette Thorn Sørensen, phone: +45 41 38 43 00 or email: mts@moleculeconsultancy.com

About injectable irons

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.

About heavy metal impurities

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.

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.