Possibility of Sensitization to CIDEX OPA Solution with Repeated Exposure – For Health Professionals

Health Canada Endorsed Important Safety Information on CIDEX OPA Solution

June 8, 2004

Subject: Product Notification CIDEX OPA Solution - Labeling Change

Dear Health Care Professional,

Advanced Sterilization Products (ASP) has received reports suggesting the possibility of sensitization to CIDEX^® OPA Solution with repeated exposure. Accordingly, ASP has made additions to the product Instructions for Use (IFU). This action has been taken in keeping with our commitment to customer education, and the safe and proper use of our products.

In Summary:

• Reports have been received suggesting the possibility of sensitization to CIDEX OPA Solution with repeated exposure.
• In rare instances CIDEX OPA Solution has been associated with anaphylaxis-like reactions in bladder cancer patients undergoing repeated cystoscopies.
• CIDEX OPA Solution should not be utilized to process instrumentation for patients with known sensitivity to CIDEX OPA Solution or any of its components.

In rare instances CIDEX OPA Solution has been associated with anaphylaxis-like reactions in bladder cancer patients undergoing repeated cystoscopies. Therefore, ASP is contraindicating the use of CIDEX OPA Solution for the reprocessing of any urological instruments to be used on patients with a history of bladder cancer.

Additionally, we received reports that, in rare instances, healthcare workers experienced an irritation or possible allergic reaction that may be associated with exposure to CIDEX OPA Solution. It appears that in most of these cases the healthcare workers were not using the product in a manner consistent with the Instructions for Use.

In order to reduce the risk of residual disinfectant exposure to your patients, please make sure to follow all recommendations in the IFU, and especially the instructions for cleaning and rinsing instruments between disinfection with CIDEX OPA Solution and actual use of instruments. In addition, please ensure that users wear the necessary personal protective equipment and process instruments in a well-ventilated area, as described in the product IFU.

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of serious and/or unexpected adverse reactions in patients receiving CIDEX OPA Solution should be reported to Johnson & Johnson Inc. or Health Canada at the following addresses:

ASP a Business Unit of Johnson and Johnson Medical Products, Division of Johnson and Johnson Inc.
200 Whitehall Dr.
Markham ON
L3R 0T5
1 800 370 4632

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

Thank you for your continued support of ASP and our CIDEX^® Family of Products. As always, ASP remains committed to protecting your patients and your staff.

Should you have any questions about the labeling change or require technical information, please contact ASP Customer Support at 1-800-370-4632.

Regards,

original signed by

Cathy Morin
Director Regulatory & Quality Systems