Advisory

2002-43
June 4, 2002
For immediate release

Important safety reminder for patients using gentamicin sulfate-containing ear drops

OTTAWA - Health Canada, following a review of current safety information and medical literature, is advising Canadians of important safety concerns related to the risk of ear toxicity with the use of gentamicin sulfate-containing ear drops in patients with a non-intact eardrum.

This safety information applies to all gentamicin sulfate-containing ear drops including GARASONE® and GARAMYCIN® from Schering Canada Inc, PMS-Gentamicin Otic Drops 0.3% from Pharmascience Inc., SAB-Gentamicin and SAB-Pentasone from Sabex Inc., and Garatec Otic Dps 5mg/mL from Technilab Pharma Inc. Gentamicin sulfate-containing ear drops are available in Canada as prescription drugs for use in treatment of bacterial ear infection.

In patients with non-intact eardrum (broken, perforated or absent eardrum or with presence of surgical ear tubes), use of gentamicin sulfate-containing ear drops has been associated with ear damage. There have been more than 20 reports of ear toxicity with gentamicin sulfate-containing ear drop preparations in Canada. Most of the cases were reported in patients with non-intact eardrums. Signs of ear damage are: hearing loss, ringing in the ears, dizziness or imbalance. If you note any of these symptoms, stop the use of gentamicin sulfate-containing ear drops and contact your physician immediately.

Patients with a non-intact eardrum (broken, perforated or absent eardrum or with presence of surgical ear tubes) SHOULD NOT use GARASONE®, GARAMYCIN® or other gentamicin sulfate-containing ear drops.

GARASONE®, GARAMYCIN® or other gentamicin sulfate-containing ear drops should only be used for the duration of time prescribed by your physician. The condition of your ear and the need for gentamicin sulfate-containing ear drops should be reevaluated by your physician five to seven days after the start of treatment and thereafter on a regular basis.

This advisory is in addition to letters issued by the manufacturer of GARASONE® and GARAMYCIN®, following discussions with Health Canada, to health care professionals reminding them of the above mentioned safety concerns.

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Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189

Public Inquiries:
(613) 957-2991