Anemia drugs recalled over glass flakes

Posted on Oct 2, 2010 in Uncategorized

Shards could develop in vials of Epogen and Procrit, say drug makers Advertisement | ad info

.By Deena Beasley


updated 9/24/2010 2:08:49 PM ET

Share Print Font: +-LOS ANGELES — Amgen Inc is recalling hundred of lots of anemia drugs Epogen and Procrit, sold by Johnson & Johnson, because vials of the injectable medicines might develop tiny glass flakes that could cause blood clots and other serious health problems.

Amgen, which sells Epogen, manufactures the identical drugs at a plant in Puerto Rico.

Amgen spokeswoman Emma Hurley said the recall, which included 200 lots of Epogen, is not expected to disrupt the availability of the drug. J&J spokeswoman Lisa Vaga said 155 lots of Procrit were recalled.

..Amgen said there have been no patient complaints that can be directly attributed to the presence of glass. It said the lots were being voluntarily recalled as a precaution.

The glass flakes result from the interaction of the drug with glass vials over the shelf life of the product, the company said.

Hurley said expiration dates for the drugs have been reduced to 12 months for single-dose vials and 15 months for multi-dose vials. Their shelf life had been 36 months.

Amgen sells Epogen in the United States, where it is used mostly for kidney dialysis patients, and J&J’s Centocor Ortho Biotech unit distributes Procrit in the United States, mainly for cancer and HIV patients. J&J has been dealing with a rash of recalls of its consumer medicines.

“From an investor standpoint, I don’t think there’s any real impact at all,” said Cowen & Co analyst Eric Schmidt. “There’s no patient safety issue, no one’s been harmed here. There’s no supply issue. There will be plenty of supply to go around.”

Amgen said the recall is being conducted in cooperation with the U.S. Food and Drug Administration.

The drugs have been blockbuster products for the companies, but their sales and those of other anemia drugs have been badly hurt in recent years by concerns over potential heart risks from overly high doses of the drugs, which are used to boost red blood cells.

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