Cosopt (dorzolamide hydrochloride/timolol maleate) Preservative-Free Ophthalmic Solution - Risk of Eye Injury - For Health Professionals

Starting date:

February 3, 2014

Posting date:

February 7, 2014

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-37909

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This is duplicated text of a letter from Merck 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 COSOPT (dorzolamide hydrochloride/timolol maleate) Preservative-Free Ophthalmic Solution

February 3, 2014

Dear Health Care Professional:

Subject: Potential Risk of Eye Injury with COSOPT^® (dorzolamide hydrochloride/timolol maleate) Preservative-Free Ophthalmic Solution - due to Change in Unit Dose Pipette Design

Merck Canada Inc., in consultation with Health Canada, would like to bring to your attention the potential risk of eye injury that can occur due to a change in the design of the unit dose pipette for COSOPT^® Preservative-Free Ophthalmic Solution and to provide instructions for appropriate administration. To minimize the potential risk of eye injury, please follow the instructions below.

• Eye injury such as cuts or scratches can occur with COSOPT^® Preservative-Free unit dose pipettes.
• The design of the unit dose pipette has been modified from a conical tip to a new tip with fins (as shown below) that includes plastic left in place after the tab is twisted off.
  
  
• To minimize the risk of eye injury in patients that require a preservative-free formulation, health professionals should:
  • Ensure that the tip or fins of the pipette do NOT touch the eye or areas around the eye;
  • When possible recommend that a caregiver administer the dose of COSOPT Preservative-Free for the patient;
  • Instruct patients or caregivers to hold the pipette so that the fins located at the tip of the pipette are aligned side-to-side to the corners of the eye, as shown in the following image.
    
    

Health Canada is aware of 9 reports of eye injury that may be associated with the use of the fin-tipped pipette. Merck Canada Inc. is working to introduce to the market a new revised pipette design later in 2014. In the interim, Merck Canada Inc. has introduced a warning sticker on the outer carton and updated the instructions in the product information.

COSOPT^® (dorzolamide hydrochloride and timolol maleate) and COSOPT^® preservative-free formulation (without benzalkonium chloride as the preservative) are indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma, when concomitant therapy is appropriate.

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 eye injury or adverse reactions/product complaints in patients receiving COSOPT^® Preservative-Free should be reported to Merck Canada Inc. or Health Canada. Medication errors can also be reported to the Institute for Safe Medication Practices (ISMP) Canada through the Canadian Medication Incident Reporting and Prevention System.

Merck Canada Inc., Pharmacovigilance
16750 Trans-Canada Hwy.
Kirkland, Québec H9H 4M7
Fax: 1-800-369-3090

To correct your mailing address or fax number, contact Merck 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, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

If you have any questions regarding this important information or for any medical inquiries, please call the Merck Canada Medical Information Department at 514-428-8600 or 1-800-567-2594, or Health Canada at the number listed above.

Sincerely,

original signed by

Mauricio Ede, M.D.
Medical Director, Medical Affairs

^® Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.

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