Amgen, Johnson & Johnson Anemia Drugs EPOGEN and PROCRIT Recalled Over Glass Flakes

THOUSAND OAKS, Calif., Sept. 24 /PRNewswire/ -- Amgen (Nasdaq: AMGN) announced today that certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.

Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a low potential to impact patients who may have received the affected product. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity. To date, there have been no complaints or adverse events reported which can be directly attributed to the presence of glass lamellae.

The affected product lot numbers and expiration dates are included in the table below and at www.epogen.com and www.procrit.com.

Adverse events related to EPOGEN should be reported to 1-800-77-AMGEN. Adverse events related to PROCRIT should be reported to 1-800-547-6446. Consumers with questions regarding this recall can contact Amgen at 1-800-77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at 1-800-547-6446 (open 24 hours per day, 7 days per week).

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

Amgen and Centocor Ortho Biotech Products and their affiliate companies have initiated recall letters and other communication to immediately inform relevant stakeholders, including healthcare professionals, distributors, wholesalers and pharmacies of the voluntary recall. The letters include instructions to return the referenced product to the returned goods service provider.

The recall is being conducted in cooperation with the United States Food and Drug Administration.

EPOGEN and PROCRIT are manufactured in the United States by Amgen. EPOGEN is sold by Amgen in the United States. Centocor Ortho Biotech Products is the authorized distributor of PROCRIT in the United States.

About EPOGEN (Epoetin alfa)

EPOGEN is indicated for the treatment of anemia in patients with chronic renal failure on dialysis. EPOGEN is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

PROCRIT is licensed from Amgen and manufactured by Amgen in Puerto Rico.

IMPORTANT SAFETY INFORMATION

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Chronic Renal Failure:

• In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
• Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (see WARNINGS: Table 1).
• To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
• Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense PROCRIT to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
• Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
• ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
• Discontinue following the completion of a chemotherapy course.

Perisurgery: EPOGEN®/PROCRIT® (Epoetin alfa) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

(See WARNINGS: Increased Mortality, Serious Cardiovascular Events, Thromboembolic Events, and Stroke, WARNINGS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)

• ESAs are contraindicated in patients with uncontrolled hypertension.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com/.

Forward-Looking Statements

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List of EPOGEN lots subject to the voluntary recall: