Amgen, FDA Warn of Counterfeit Drug

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 Wednesday.

The letters say the counterfeit vials contain Epogen’s active ingredient, but the concentration is about 20 times lower than it should be. The counterfeit drugs were found in one batch of 10-pack boxes containing 40,000 units of the medicine.

Amgen, based in Thousand Oaks, wouldn’t say how many patients may have received the counterfeit product or offer any further details about the problem.

About 150,000 patients take Epogen, Amgen’s best-selling drug, which racked up almost $2.2billion in sales last year.

This is the second time in a year that counterfeit doses of an Amgen medicine have been discovered. In June, phony vials of Neupogen, a drug given to chemotherapy patients to help fight infections, were discovered.

“We don’t see this as someone targeting Amgen,” company spokesman Jeff Richardson said Monday. “Incidents of counterfeiting just crop up once in a while.”

Both incidents are the subject of a criminal investigation, Richardson said.

Amgen’s drugs make attractive targets for counterfeiters because they are expensive.

The 10-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,” Harp said.

Since the beginning of the month, two other drug companies have reported product problems that could have harmed patients. Eli Lilly & Co. warned that a few bottles of its psychiatric drug Zyprexa contained white tablets marked aspirin. Last week, GlaxoSmithKline said four bottles of AIDS drug Combovir actually contained another AIDS drug called Ziagen. Both companies are investigating the problem.