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NEW YORK (AP) - Amgen Inc. and the Food and Drug Administration warned that counterfeit vials of Epogen, an anemia drug given to dialysis patients, have been discovered.
Letters have been sent to doctors, pharmacists and drug wholesalers to alert them to the problem, which was announced on the Web sites of the FDA and Amgen, the maker of Epogen, on May 8.
The letters say the counterfeit vials contain Epogen's active ingredient, although the concentration is approximately 20 times lower than it should be. The counterfeit drugs were found in one batch of ten-pack boxes containing a total of 40,000 units of the medicine. Amgen wouldn't say how many patients may have received the counterfeit product or offer any further details about the problem.
There are about 150,000 patients taking Epogen, Amgen's best selling drug that racked up almost $2.2 billion in sales last year.
This is the second time in a year that counterfeit doses of an Amgen medicine have been discovered. Last June, phony vials of Neupogen, a drug given to chemotherapy patients to help fight infecti
ons, were discovered.
"We don't see this as someone targeting Amgen," company spokesman Jeff Richardson said Monday. "Incidents of counterfeiting just crop up once and a while."
Both incidents are the subject of a criminal investigation, said Richardson.
Amgen's drugs make attractive targets for counterfeiters because they are expensive. The ten-pack box of Epogen would retail for about $4,000 said Dennis Harp, a biotech analyst at Deutsche Bank Securities. "If counterfeiters are going to take a risk, they are going to target high value products," said Harp.
It is believed that about one in eight medicines sold on the world market is counterfeit, said Jeff Trewitt, spokesman for the Pharmaceutical Research and Manufacturers of America, the industry trade group. Last year, there was a flurry of high profile counterfeit drug cases. Phony versions of a growth hormone made by Genentech Inc. and an AIDS (news - web sites) medicine by Serono were discovered around the same time as the bogus Neupogen
Trewitt says it is difficult to say whether the problem is getting worse. "It is a serious, consistent problem," he said.
Since the beginning of the month, two other drug companies have reported product problems that could have potentially harmed patients. Eli Lilly & Co. warned that a few bottles of its psychiatric drug Zprexa contained white tablets marked aspirin. Last week. GlaxoSmithKline said that four bottles of AIDS drug Combovir actually contained another AIDS drugs called Ziagen. Both companies are investigating the problem.
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