Omontys US recall
February 25, 2013
THE US FDA is alerting health care
providers and patients of a
voluntary recall of all lots of
Omontys Injection by Affymax and
Takeda Pharmaceuticals.
Omontys is used in the US to treat
anemia in adult dialysis patients.
The recall is due to reports of
anaphylaxis, a serious and lifethreatening
allergic reaction, with
Affymax having informed the FDA
of 19 reports of anaphylaxis from
dialysis centers in the US, three of
which resulted in death.
Other patients required prompt
medical intervention and in some
cases hospitalisation, where
patients were able to be
resuscitated by doctors.
“Due to the severity of the public
health risk, we want to be certain
that health care providers stop
using Omontys,” said Howard
Sklamberg, director, Office of
Compliance, FDA’s Center for Drug
Evaluation and Research.
As such the FDA has advised that
until further notice, health care
providers in the US should stop
using Omontys and return the
product to Takeda Pharmaceuticals.
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