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Health professional risk communication

ACLASTA (zoledronic acid 5 mg/100 mL) - Volume overfill in vials of solution for intravenous infusion - For Health Professionals

Starting date:
July 8, 2013
Posting date:
July 8, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-34489

This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on ACLASTA (zoledronic acid) Lot 16FG0209

July 8, 2013

Dear Health Care Professional,

Subject: Volume overfill in vials of ACLASTA* (zoledronic acid 5 mg/100 mL) solution for intravenous infusion – Lot 16FG0209

Novartis Pharmaceuticals Canada Inc. (“Novartis”), in collaboration with Health Canada, would like to provide you with information on a reported volume overfill for ACLASTA* vials (zoledronic acid 5 mg/100 mL) involving a single lot (lot number: 16FG0209). Please note however that there is no product recall for this lot.

ACLASTA* is approved for the treatment and prevention of osteoporosis in postmenopausal women, to increase bone mass in men with osteoporosis, for treatment and prevention of glucocorticoid-induced osteoporosis and for the treatment of Paget’s disease of bone.

The current in-process specifications for ACLASTA* normally permit an overfill of up to 4 mL of solution in the vial. However, vials from this lot could contain an overfill up to 6 mL of ACLASTA*. All other aspects of product quality remain unaffected. 

  • There has been a reported volume overfill of vials of ACLASTA*. Although the additional volume is unlikely to represent a serious risk to patients, those who have renal impairment or are dehydrated may be more susceptible to adverse renal effects.
  • If you are going to administer product from this particular lot of ACLASTA* (lot 16FG0209), please ensure that only 100 mL of the product is administered, as per the product label. 

Novartis has taken appropriate corrective measures to ensure that all future lots are manufactured in accordance with the product specifications as approved by Health Canada. No other lots of ACLASTA* sold in Canada are impacted.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious overdose symptoms or other serious or unexpected adverse reactions in patients receiving ACLASTA* should be reported to Novartis Pharmaceuticals Canada Inc. or Health Canada at the following addresses:

Novartis Pharmaceuticals Canada Inc.
385 Bouchard blvd,
Dorval, Quebec, H9S 1A9
Phone: 1-800-363-8883 (Medical Information)

To correct your mailing address or fax number, contact Novartis Pharmaceuticals Canada Inc.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by: 

  • Calling toll-free at 1-866-234-2345; or
     
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

For other health product inquiries related to this communication, contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Tel: 1-800-267-9675
Fax: 613-946-5636

Should you have any questions or require additional information regarding the use of ACLASTA* (zoledronic acid), please contact Novartis Pharmaceuticals Canada Inc., Medical Information Department at 1-800-363-8883.

Sincerely,

original signed by

Jean Godin, M.D.
Chief Scientific Officer and Vice President, Clinical and Regulatory Affairs

*ACLASTA is a registered trademark