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
baby pigs.
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
baby pigs, 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 Injectable Iron
Baby pigs are very susceptible to iron
deficiency anemia. Therefore, iron deficiency anemia in
litters of baby pigs poses a risk to both animal health, welfare,
and productivity. An injection of iron shortly after farrowing is
an effective and is a globally established "best practices method"
utilized to prevent iron deficiency anemia in baby pigs.
About Uniferon 200
Uniferon 200 is a modern and much improved iron hydrogenated
dextran, based upon a very low impurity profile formulation,
whereby this source of injectable iron for baby pigs has been
approved by numerous healthcare authorities for global use.
Pharmacosmos manufactures iron dextran of high quality and
unique purity, which is distributed to human and animal drug
customers worldwide. Uniferon 200 is the only injectable iron brand
for baby pigs approved by healthcare authorities in the EU, in the
U.S. and in Asia.
About Pharmacosmos
Pharmacosmos Inc, located in Watchung, NJ as a fully owned
subsidiary of Pharmacosmos A/S. is dedicated to the sales of
veterinary pharmaceuticals for the treatment and prevention of iron
deficiency Anemia, including Uniferon 200.
Headquartered in Holbaek, Denmark, Pharmacosmos A/S 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, the Pharmacosmos A/S ongoing R&D
program focuses on improving the lives of patients with
sub-clinical and full-scale iron deficiency anemia. More than 1
billion people live with iron deficiency anemia and it is the
leading cause of death for an estimated 180,000 people world-wide
every year. This makes sub-clinical and full-scale iron deficiency
anemia one of the largest global health challenges of the current
time.
Pharmacosmos A/S has subsidiaries in the US, China, Nordics,
Germany, UK and Ireland, and its products are marketed in more than
80 countries around the world. The Pharmacosmos A/S manufacturing
facilities located in Denmark have supported global healthcare
authority approvals, among others, by the Danish Medicines Agency
and the U.S. FDA.