Health Canada issues warning about timolol ophthalmic solution in 0.25% and 0.5% concentrations

OTTAWA — Health Canada has warned patients with ocular hypertension and glaucoma to discontinue using Sandoz timolol ophthalmic solution in 0.25% and 0.5% concentrations due to the increased risk of adverse events that could occur because some bottles may contain more timolol maleate than indicated on the label, the agency announced in a press release.

Potential adverse events may include red eye, eye irritation, inflammation of the eyelid and 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, the release said.

The agency has advised patients to discontinue using Sandoz timolol ophthalmic solution eye drops in both 0.25% and 0.5% concentrations and to consult their health care practitioner immediately to ensure that IOP treatment is not interrupted. Consumers should return the product to their pharmacist for safe disposal.

The drug's manufacturer, Sandoz Canada — a generic drug subsidiary of Novartis — is recalling the products, and Health Canada plans to monitor the effectiveness of the recall.

The agency expects Sandoz to issue a separate release notifying physicians and pharmacists of the recall.