Recall Of Sandoz Timolol Ophthalmic Solution 0.25% And Sandoz Timolol Ophthalmic Solution 0.5% Due To Potential Health Risk, Canada

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Jul 2008 - 2:00 PDT

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Health Canada is warning consumers not to use the prescription drug Sandoz Timolol Ophthalmic Solution in 0.25% and 0.5% strengths, because some bottles may contain more of the active ingredient (timolol maleate) than indicated on the label, exposing patients to an increased risk of adverse events.

Sandoz Timolol Ophthalmic Solution 0.25% and 0.5% are eye drops taken for treatment of increased intraocular pressure (high fluid pressure inside the eye) and glaucoma.

Potential adverse events may include red eye, eye irritation, inflammation of the eyelids and/or cornea, drooping of the upper eyelid, double vision, dizziness, headache, abnormally slow heartbeat, abnormally low blood pressure, shortness of breath, difficulty breathing, and cardiac failure.

Patients taking either Sandoz Timolol Ophthalmic Solution 0.25% or 0.5% eye drops should discontinue use and consult their health care practitioner immediately to ensure that treatment of the original condition (intraocular pressure) is not interrupted. Consumers should return the product to their pharmacist for safe disposal.

The manufacturer, Sandoz Canada Inc., is recalling the products, and Health Canada is continuing to monitor the effectiveness of this recall. A separate communication will be sent by Sandoz to doctors and pharmacists notifying them of the recall.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To date, there have been no cases of adverse reactions linked to the use of this product reported in Canada. To report a suspected adverse reaction to this product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the Health Canada Web site.

Health Canada
http://www.hc-sc.gc.ca