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Archived – Important Drug Warning – Garasone / Garamycin – Schering Canada Inc.
- Starting date:
- May 30, 2002
- Posting date:
- May 30, 2002
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- Healthcare Professionals
- Identification number:
- RA-17000325
This is duplicated text of a letter from Schering Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
Important Safety Information: GARASONE® /GARAMYCIN®
May 30, 2002
Dear Health Care Professionals:
Schering Canada Inc., in consultation with Health Canada, would like to inform you of the risk of ototoxicity with the use of topical GARASONE® and GARAMYCIN® eardrops in patients with perforated tympanic membranes.
As per the Canadian Adverse Drug Reaction Newsletters dated April 1997 and January 2001:
Precautions
To minimize the risk of ototoxicity, the following precautions are suggested: GARASONE® or GARAMYCIN® eardrops should be used for the shortest duration possible; the patient should be instructed precisely regarding the dosage and duration of therapy. Treatment should be discontinued if hearing loss, tinnitus, vertigo, or imbalance is noted. The use of GARASONE® or GARAMYCIN® eardrops should be reassessed, with respect to ototoxicity, 5-7 days after start of treatment and thereafter on a regular basis.
GARASONE® and GARAMYCIN® eardrops are contraindicated in patients with absent or perforated tympanic membranes.
Adverse Reactions
During the post-marketing of gentamicin-containing otic preparations, rare cases of ototoxicity (hearing loss, tinnitus, vertigo, imbalance, ataxia or oscillopcia) in the presence of tympanic membrane perforation or tympanoplasty tubes have been reported. Ototoxicity was primarily vestibular and was generally associated with prolonged treatment duration. However, ototoxicity with treatment durations of 5 to 7 days has also been reported. In some instances, patients have not recovered from their symptoms (hearing loss, tinnitus, vertigo, imbalance, ataxia or oscillopcia). The possibility of ototoxicity following otic application should be kept in mind, and the patient monitored accordingly on a regular basis.
Dosage and Administration
The need for GARASONE® and GARAMYCIN® eardrops should be reassessed, with respect to ototoxicity, 5-7 days after start of treatment and thereafter, on a regular basis.
This notice is applicable to all gentamicin-sulfate containing otic products regardless of the manufacturer.
The identification, characterization, and management of drug-related adverse events are dependent on the active participation of healthcare professionals in adverse drug reaction reporting programmes.
Any occurrences of ototoxicity or other serious and/or unexpected adverse events in patients receiving GARASONE® or GARAMYCIN® eardrops should be reported to Schering Canada Inc. or the Marketed Health Products Directorate at the following addresses:
Schering Canada Inc.
3535 Trans-Canada, Pointe-Claire, Que., H9R 1B4
Tel: 1-800-463-5442 or Fax: 1-800486-0765
e-mail: medical.services@spcorp.com
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use. Kindly note that this letter has been distributed to all Canadian physicians, pharmacies, relevant professional associations as well as hospital Chiefs of Medical Staff (note to hospital Chief of Medical Staff: additional copies of this letter have been provided for the internal distribution to all other hospital department heads). We, Schering Canada, encourage the posting of this letter on relevant websites or the publishing of this letter in appropriate journals or newsletters.
Should you have any questions or require further information regarding the use of GARASONE® or GARAMYCIN® eardrops, please contact Schering Canada's Medical Services at 1-800-463-5442 or fax to 1-800-486-0765 or e-mail at medical.services@spcorp.com.
original signed by
Patrice Larose, B.Pharm., Ph.D.
Director, Regulatory Affairs, Drug Safety & Medical Services
Schering Canada Inc.
Any suspected adverse drug reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Bureau of Licensed Product Assessment
Therapeutic Products Directorate
Health Canada
Address Locator: 0201C2
Ottawa, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The ADR Reporting Form can be found in The Canadian Compendium of Pharmaceuticals and Specialties, or on the TPD website, along with the ADR Guidelines.
Affected products
Product
Place of origin
Matt Test 11 3