The most popular anemia drugs, Epogen and Procrit, manufactured by Amgen, California- based company have been recalled because of possibility of glass flakes in the injection vial. Both Procrit and Epogen are the same drug, marketed under different names by different companies. Epogen is marketed by Amgen directly for kidney-failure patients on dialysis, and Procrit is licensed to Johnson and Johnson for cancer patients on chemotherapy and some HIV-infected patients.
The recall applies to 324,000 Procrit vials that remain on the market. Amgen said that the glass flakes are formed due to the interaction of the drug with glass vials over the shelf life of the product. However, these flakes are barely visible in most cases. There has been no complaint recorded so far related to both the drugs, but use of glass flakes tainted vials can cause blood clots, swelling of veins, immune system reactions and other problems. Patients experiencing any problems after using the drugs should contact their doctor and notify the Food and Drug Administration and either Amgen or Johnson & Johnson’s Centocor subsidiary.
In addition to the recall, Amgen is changing...
the vials and reducing the shelf life of the product to 12 months from 36 months to make sure the safety of the drug.
Epogen is Amgen’s fourth-best-selling product, which contributed $2.57 billion sales in 2009. However, Procrit contributed $2.25 billion for J&J. Both drugs contain erythropoietin, which is a synthetic form of the naturally occurring hormone produced in the kidney. The drugs stimulate the production of red blood cell in patients with anemia caused by HIV treatment, chronic renal failure or chemotherapy.
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.