Company warns of counterfeit
drug
By Michael O'Leary
SEATTLE -- May 17,
2001 (Cancer Digest) -- In a potentially life-threatening case
of counterfeiting, someone is distributing a fake version of
a drug commonly used by cancer patients undergoing chemotherapy.
The drug called Neupogen®
is manufactured by Amgen, of Thousand Oaks, Calif. and is primarily
used to prevent infections caused by the loss of white blood
cells killed by chemotherapy agents. The counterfeit has been
packaged carefully in 10-pack boxes of vials that look much like
the real thing.
In a letter to physicians,
on May 10, Amgen warned that the counterfeit product, which is
definitely not Neupogen (filgrastim), was neither manufactured
nor distributed by Amgen and may pose a serious health risk to
patients.
David Kaye, Amgen's
associate director of corporate communications says that there
is no active drug in the vials.
"In the vials
we've tested, all we've found is a normal saline, almost like
a placebo in a clinical trial," Kaye told cancerfacts.com.
"There's nothing harmful in them, but there is nothing helpful
either, which can be serious for patients whose white blood cells
counts are very low."
How widespread the
distribution of the fake vials has been, Kaye wouldn't say. "We're
cooperating with the FDA investigators and they have asked that
we not divulge where or how much of the counterfeit product has
been found."
Earlier this year,
however, in a similar instance, Amgen issued a letter to physicians
regarding another of its products called Epogen®, which is
used primarily by kidney dialysis patients. In that letter, the
company stated that three incidences of product tampering had
occurred involving eight vials.
In that case, Amgen
vials had been opened and the contents replaced with various
amounts of a solution in an apparent attempt to conceal product
theft.
In the new case, commercial
vials not used by Amgen have been filled with saline, labeled
and packaged in boxes to look like Amgen's product. Whether the
two cases are related is unknown.
The company has posted
detailed lists of ways to distinguish the genuine Neupogen product
from the counterfeit along with side-by-side photos on their
Web site.
Anyone suspecting that
they have received a batch of bogus vials are urged to seperate
the product and contact the FDA immediately at 1 800 835 4709.
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