Archived – Safety Update: Updated Information About EPREX (epoetin alfa) Provided to Canadian Healthcare Professionals – Janssen-Ortho Inc. and Ortho Biotech – For the Public

IMPORTANT DRUG SAFETY UPDATE FOR CONSUMERS

Toronto, July 4, 2002

Safety update: updated information about EPREX* (epoetin alfa) provided to Canadian healthcare professionals

The following updated safety information has been provided recently to healthcare professionals to review with their patients when prescribing and dispensing EPREX*.

EPREX* has been approved in Canada since 1990 for the treatment of anemia in patients with chronic renal failure (CRF). From 1998 through April 30, 2002, 121 worldwide cases of suspected pure red cell aplasia (PRCA) have been reported in patients with CRF from the post-marketing experience with EPREX*. As of April 30, 2002, there have been 27 reports of suspected PRCA in CRF patients in Canada. The majority of worldwide reports that the Company is aware of have been associated with EPREX, however, cases of suspected PRCA have also been reported with similar products in other countries. PRCA is a condition in which a patient develops severe anemia due to failure of the bone marrow to produce red blood cells and is characterized by a severe and sudden anemia accompanied by the feeling of tiredness or shortness of breath.

EPREX* is approved to be administered by injection under the skin (subcutaneous) or into the veins (intravenous). Available scientific information suggests that the subcutaneous route of administration for some medicines, such as EPREX, may increase the likelihood of the body producing substances (antibodies) that could reduce the effectiveness of the medicine and possibly lead to events such as PRCA. Based on reported information, the majority of PRCA cases have been seen with the subcutaneous route of administration, the predominant route of administration in most countries. The Company has communicated to healthcare professionals that where feasible, EPREX should be administered intravenously to patients with CRF while the Company investigates the cause of this adverse event.

Should a patient with chronic renal failure on EPREX* suddenly feel tired or have sudden shortness of breath, they should immediately see their doctor. Patients should NOT discontinue their medication without seeing their doctor first.

As with all medicines, EPREX should not be used by anyone who does not require the drug to treat a disease or its symptoms.

Updated information for healthcare professionals is available at http://www.janssen-ortho.com

Janssen-Ortho Inc., a Johnson & Johnson company, is a research-based pharmaceutical company located in Toronto.

*All trademark rights used under license

For further information: Simone Philogène, Director of Communications, Janssen-Ortho Inc., (416) 449-9444, Ext. 4864. Or call the Janssen-Ortho Medical Information Department at 1-800-567-3331, from 9 a.m. to 5 p.m. Monday to Friday, EST.

Any suspected adverse drug reactions can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0201C2

OTTAWA, Ontario, K1A 1B9

Tel: (613) 957-0337 or Fax: (613) 957-0335

Toll free for consumers and health professionals:

Tel: 866 234-2345, Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

The ADR Reporting Form can be found in The Canadian Compendium of Pharmaceuticals and Specialties, or on the TPD website, along with the ADR Guidelines.