Amgen recalls anemia drugs due to glass flakes
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[September 25, 2010]
TTRENTON, N.J. -- Amgen Inc. is
recalling some lots of its blockbuster Epogen and Procrit anemia
treatments because the injected drugs may contain glass flakes that
could cause blood clots, swelling of veins, immune system reactions
and other problems.
The Thousand Oaks, Calif., biotechnology company
says the flakes are barely visible in most cases, and they have
fielded no complaints or reports about problems that can be directly
tied to them. Patients experiencing problems should contact their
Amgen says the flakes are caused by the interaction of the drug with
glass vials over the product's shelf life.
The affected lot numbers and expiration dates can be found on
websites for the products, and patients can call 1-800-77-AMGEN to
ask questions. Patients harmed by the recalled products, or their
doctors, should notify the Food and Drug Administration and either
Amgen or Johnson & Johnson's Centocor subsidiary.
This is not the first recall this year over a liquid medicine
containing glass particles.
Baxter International announced a recall on May 17 for its
genetically engineered Hylenex, a solution for rehydrating sick
children. Baxter officials also said bits of glass had peeled off
the inside of vials.
Epogen treats anemia in patients with chronic renal failure who are
on dialysis. Procrit also treats it for cancer patients on
chemotherapy and some HIV-infected patients.
Amgen makes both products at plants in Puerto Rico. It has long had
a deal under which Johnson & Johnson sells Procrit in the U.S. The
drugs work by stimulating production of oxygen-carrying red blood
cells, which reduces anemia and can decrease the need for blood
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Sales of the products have declined somewhat in recent years because
of restrictions by the U.S. Centers for Medicare and Medicaid
Services over concerns that higher doses of the drugs can be
dangerous. Research has shown the medicines are linked to increased
risk of death, heart attack, stroke, life-threatening blood clots
and growth of tumors in cancer patients.
Amgen reported $2.6 billion in 2009 sales for Epogen, its No. 2
best-selling drug. Johnson & Johnson posted 2009 sales of $2.2
billion worldwide for Procrit and a similar drug it sells overseas
Shares of Amgen rose 46 cents to $56.18 in late morning trading
Press; By LINDA A. JOHNSON]
AP Business Writer Tom
Murphy reported from Indianapolis.
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