Heavy metal impurities found in 94 percent of tested injectable irons for piglets

Thu, 10 May 2018

New data shows 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 baby pigs

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 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 Professor Jens Peter Nielsen, DVM, PhD, 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 independent FDA-certified 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 recognised 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 lead and arsenic, can have negative effects on human health, toxic heavy metals such should not be knowingly injected into food production animals,” says Professor Steve Ensley from Veterinary Diagnostic Laboratory, Vet Diagnostic & Production Animal Medicine, DVM, MS, PhD and co-author to 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] This is not currently the case for veterinary products, therefore, there are no limits for heavy metal impurities in products for veterinary use.

“As the new study shows, iron is not just iron. Even products with the same generic name can differ in level 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 built through 50 years of focus on the treatment of iron deficiency anaemia,” adds Dr Christensen.


To read the full publication, click here


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

[2] US Environmental Protection Agency. Air quality criteria for lead (final report, 2006). October 2006. https://cfpub.epa.gov/ncea/ risk/recordisplay.cfm?deid=158823 (accessed Feb 12, 2018).

[3] Navas-Acien A et al. Lead exposure and cardiovascular disease: a systematic review. Environ Health Perspect 2006; 115:472– 82.

[4] Cossleman KE et al. Environmental factors in cardiovascular disease. Nat Rev Cardiol2015; 12:627–42.

[5] Lanphear BP et al. Low-level lead exposure and mortality in US adults: a population-based cohort study. Lancet Public Health 2018; 3: e177–84.

[6] Landrigan PJ. Lead and the heart: an ancient metal’s contribution to modern disease. Lancet Public Health 2018; 3: e156-57.

[7] http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180284.pdf