Important Drug Warning Counterfeiting of Epogen(R)
IMPORTANT DRUG WARNING
COUNTERFEITING OF EPOGEN(R)
May 24, 2002
|ADDITIONAL COUNTERFEIT LOTS
||Amgen Inc. is updating its information
to patients, physicians, pharmacies, and wholesalers to report additional
counterfeit EPOGEN(R) (Epoetin alfa). In addition to lot number P002970,
discussed in the notice below dated May 8, 2002, the following lot numbers
contain counterfeit drug product.
| EPOGEN(R) 40,000 U/ml
| Lot Number: P001091
| Lot Number: P001486
Please carefully review the information below in examining
EPOGEN(R) before use.
May 8, 2002
Dear Health Care Professional:
Amgen Inc. recently became aware of the existence in the
U.S. of a counterfeit drug product labeled as EPOGEN(R) (Epoetin alfa) 40,000
U/ml vials in ten-pack boxes, lot number P002970 and expiration 7/03. In cooperation
with the U.S. Food and Drug Administration (FDA), Amgen is informing patients,
physicians, pharmacies, and wholesalers about this potentially serious health
risk. EPOGEN(R) is primarily used for the treatment of anemia associated with
chronic renal failure for patients on dialysis.
The counterfeit vials examined by Amgen to date
contain a clear liquid that contains active ingredient. However, the concentration
of active ingredient is approximately 20 times lower than expected for EPOGEN(R)
40,000 U/ml vials.
Pharmacists and all other health care professionals should
carefully examine EPOGEN(R) before use. The following information may help
in determining if the product you have is counterfeit.
In order to view pictures illustrating these differences,
please log onto Amgen's web site at www.amgen.com/corporate/AmgenNews.html.
Features of authentic EPOGEN(R)
Features of counterfeit product
Amgen logo on carton closure label on exterior of
box will shift colors from blue to purple when viewed at different heights.
|Amgen logo on carton closure
label on exterior of the box lacks color shifting properties (remains blue
when viewed at different heights).
Degree sign present for storage temperature on vial
"Store at 2 to 8 C"
|Degree sign missing from storage
temperature on vial label.
"Store at 2 to 8 C"
If you receive any product that you suspect is counterfeit,
quarantine it and store it under labeled conditions. Please promptly contact
FDA for further instructions at 1 800 835 4709.
If you have questions about EPOGEN(R), please contact Amgen
Medical Information at 1 800 772 6436. Please convey this information
to your staff and any others who administer EPOGEN(R). You should instruct them
on what to look for and what to do in the event they find a suspect counterfeit
Amgen does not recommend the purchase of Amgen products
from wholesalers that do not currently purchase EPOGEN(R) directly from Amgen.
A list of wholesalers that currently purchase EPOGEN(R) directly from Amgen
can be found on its website at www.amgen.com/product/productCenter.html.
The parties on this list are the only wholesalers whom Amgen currently sells
to for distribution of its products. If you have purchased Amgen product from
another source, you should verify the origin of that product by contacting the
Amgen is cooperating fully with the FDA to investigate this
matter and prevent the further distribution of counterfeit product. To Amgen's
knowledge, the counterfeit product has only been found in distribution in the
Full product information and any updates on this situation
are available on the web at www.amgen.com.
William Sheridan, MB, BS, FRACP
Vice President, Medical Affairs
Other Contact Information:
U.S. Food and Drug Administration (for press inquiries):