Archived - Updated safety: Possible relationship of Aredia and/or Zometa with osteonecrosis of the jaw - Novartis Pharma Canada Inc. - For The Public

Starting date:

November 5, 2004

Posting date:

December 15, 2004

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000130

This is duplicated text of a letter from Novartis Pharma Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Advisory

Health Canada Endorsed Important Safety Information on Aredia* (pamidronate disodium) and Zometa* (zoledronic acid)

November 5, 2004

Subject: Updated safety information on Aredia*(pamidronate disodium) and/or Zometa*(zoledronic acid)

Following discussions with Health Canada, Novartis Pharmaceuticals Canada Inc. would like to inform you of important new safety information regarding the osteonecrosis of the jaw (ONJ) (deterioration of the jaw bone) in patients who have received Aredia*(pamidronate disodium) and/or Zometa* (zoledronic acid) as a component of their therapy. The majority of the reported cases are in cancer patients. Cases of ONJ in non-cancer patients who have received other bisphosphonates, have also been reported in the literature.

Aredia* and Zometa* are used to treat the following conditions: a) high blood calcium levels caused by tumors, b) bone metastases (i.e.: cancer that has spread from the tumor to the bone) due to different types of tumors, and c) multiple myeloma. Aredia* is also used to treat Paget's disease of the bone.

Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis (i.e: inflammation/infection of the bone).

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

In the Product Monographs for both Aredia* and Zometa*, the healthcare professionals' prescribing and patients' information have been updated to reflect the most recent data.

Novartis Pharmaceuticals Canada Inc. reiterates its commitment to the delivery of quality pharmaceutical products and is committed to ensuring the timely dissemination of new information that is important to physicians and patients.

Novartis Pharmaceuticals Canada Inc. has also issued a letter to health professionals informing them of the above-mentioned updated safety information. The letter that was sent to health professionals can be found on Health Canada website.

Novartis Pharmaceuticals Canada Inc. is working with Health Canada to evaluate the appropriate regulatory actions (e.g. update to the Canadian Product Monograph) required based on these data.

If you have questions about your current prescription, please contact your physician or pharmacist.

If you have had a serious or unexpected reaction to Aredia* and/or Zometa* you may notify either Novartis Pharmaceuticals Canada Inc. or Health Canada as follows:

Novartis Pharmaceuticals Canada Inc.

385 Bouchard blvd,

Dorval, (QC) H9S 1A9

Phone: 1-800-363-8883 (Medical Information)

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.

For media inquiries please contact Jason Jacobs at (514) 633-7872.

^PrAredia* and ^PrZometa* are registered trademarks