Amgen and Johnson & Johnson Recall Anemia Drugs EPO Procrit

Amgen and Johnson & Johnson Recall Anemia Drugs EPO Procrit

September 24, 2010
By ANDREW POLLACK
http://prescriptions.blogs.nytimes.com

Amgen’s anemia drugs have been embroiled in controversy about their safety for several years as evidence has mounted that their overuse can cause heart attacks or strokes or make cancer worse. Now comes yet another problem, though presumably a temporary one.

Amgen announced Friday morning that it and Johnson & Johnson were recalling various lots of their anemia drugs, Epogen and Procrit, because extremely thin, barely visible glass flakes have been found in the vials.

Amgen said the particles could cause clots and other problems if the drugs were given by intravenous infusion or lumps and immune system reactions if injected under the skin.

However, the company said it had received no complaints or had heard of no problems that could be “directly attributed to’’ the glass particles. A spokeswoman for Amgen, Emma Hurley, said the company’s evaluation “found a low potential to impact patients.’’

Amgen said the recall was being done in coordination with the Food and Drug Administration.

Both drugs are the same substance, a protein called erythropoietin, or epoetin alfa, which is made by Amgen in Puerto Rico. Amgen sells the protein as Epogen for the treatment of anemia in kidney dialysis patients.
Johnson & Johnson sells it as Procrit for other uses, such as for anemia caused by kidney disease that does not yet require dialysis and for anemia caused by cancer chemotherapy.

Ms. Hurley said Amgen did not anticipate that the problem would affect the availability of Epogen and would not have a material financial impact on Amgen. Johnson & Johnson also said supply of Procrit should not be affected.

Amgen discovered the flakes, she said, during a recent inspection of vials of the drug. The flakes were formed by the interaction of the drug formulation with the glass vials over the shelf life of the product.
Amgen has now reduced the shelf life to either 12 or 15 months, depending on the type of vial, from 36 months.

No recent change in the formulation of the drug would explain the problem, she said. That raises the possibility that the problem has been occurring undetected for a sometime. Epogen was first approved in 1989.

A third anemia drug, Amgen’s Aranesp, is a slightly different protein and is made separately from the other two.

Interactions between a drug and a vial are not unknown and can be serious. Several years ago, dozens of patients in Europe who were treated with Johnson & Johnson’s Eprex — basically the European version of Procrit — developed a serious condition called pure red cell aplasia, which left them dependent on blood transfusions. Johnson & Johnson eventually attributed the problem to a reaction between the drug formulation and the stoppers used in the vials.

The anemia drugs have all been huge sellers with sales of two billion dollars a year or more. But concerns have arisen in recent years that overuse of the drugs has contributed to problems like heart attacks and strokes and, in cancer patients, a worsening of the cancer.

Sales, particularly for use in treating cancer patients, have plummeted as the Food and Drug Administration has put extra warnings on the drugs’ labels and as Medicare has become more restrictive in paying for the drugs.

The F.D.A. will hold another advisory committee meeting on Oct. 18 to review the latest findings of possible harm to patients with kidney disease from the drugs.