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.