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Archived – Medication Errors Involving Reminyl and Amaryl –Janssen-Ortho Inc. and Aventis Pharma Inc.

Starting date:
December 17, 2004
Posting date:
December 21, 2004
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-17000810

This is duplicated text of a letter from Janssen-Ortho Inc. & Aventis Pharma 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 Medication Errors Involving REMINYL* (galantamine hydrobromide) and AMARYL® (glimepiride)

December 17, 2004

Subject: MEDICATION ERRORS INVOLVING REMINYL* AND AMARYL®

Dear Pharmacist:

Please be aware of the following:

Janssen-Ortho Inc. and Aventis Pharma Inc. (collectively, "the Companies") would like to inform you of reports in the United States of name confusion/medication errors involving Janssen-Ortho's product, REMINYL* (galantamine hydrobromide), a drug approved for the treatment of mild to moderate dementia of the Alzheimer's type, and AMARYL® (glimepiride), a product of Aventis Pharma Inc., indicated for the treatment of type 2 diabetes. These reports include instances in which REMINYL was prescribed but AMARYL® was incorrectly dispensed, leading to various adverse events including severe hypoglycemia. There were two reports of death. To the Companies' knowledge all reports have originated in the U.S.; we are not aware of any reports of medication errors in Canada to date.

  • There have been prescriptions incorrectly written, interpreted, labeled or filled due to the similarity in names between REMINYL* (galantamine hydrobromide) and AMARYL® (glimepiride).
  • As a result of these errors, there have been reports of various adverse events including severe hypoglycemia and fatalities.
  • Pharmacists have a pivotal role in helping to avoid such errors. The following suggestions are offered:
    • Place AMARYL® (glimepiride) and REMINYL (galantamine hydrobromide) apart from one another on the shelf. We advise use of the enclosed "shelf talker" described below.
    • Confirm the brand name prescribed on written and oral prescriptions.
    • Confirm the dose of new prescriptions for 4 mg of AMARYL® (glimepiride), since the recommended starting dose is 1 mg.
    • Counsel patients about the brand name, indication and proper use of the drug prescribed.

The Companies are aware of 36 spontaneous reports, of which 12 have been confirmed as unique (non-duplicate) reports of medication errors. The reports were of prescriptions that have been either incorrectly written, interpreted, labeled or filled due to the similarity in names between REMINYL and AMARYL®. As of August 2004, approximately 3.5 million prescriptions worldwide have been written for REMINYL.

While we recognize that medication errors have multiple causes, the pharmacist's role in avoiding such errors is pivotal. Your assistance is requested in verifying and accurately dispensing oral and written prescriptions for these two products to help avoid medication errors.

The following suggestions are offered to help decrease the potential for errors:

  • Place AMARYL® (glimepiride) and REMINYL (galantamine hydrobromide) apart from one another on the shelf. We advise use of the enclosed "shelf talker" described below.
  • Confirm the brand name prescribed on written and oral prescriptions.
  • Confirm the dose of new prescriptions for 4 mg of AMARYL® (glimepiride), since the recommended starting dose is 1 mg.
  • Counsel patients about the brand name, indication and proper use of the drug prescribed.

We have developed the following enclosed material for pharmacists to help prevent medication errors:

  • A "shelf talker" that can be used to help differentiate REMINYL (galantamine hydrobromide) and AMARYL® (glimepiride) from other stocked merchandise.

These two products have an overlapping strength (4 mg) and an overlapping dosage form (tablets). In addition, both products have generic names (galantamine vs. glimepiride) that might lead to their storage in close proximity. It is important to note that REMINYL has a starting dosage of 4 mg TWICE a day, whereas AMARYL® is usually initiated at 1 mg ONCE a day.

REMINYL is supplied for oral administration as 4 mg (off-white, circular, biconvex), 8 mg (pink, circular, biconvex), and 12 mg (orange-brown, circular, biconvex) tablets. REMINYL tablets are imprinted "JANSSEN" on one side, and "G" and the strength "4", "8", or "12" on the other side.

AMARYL® is supplied for oral administration as 1 mg (pink, flat-faced, oblong with notched sides at double bisect and imprinted with "AMARYL" on one side and with Hoechst AG logo on both sides of the bisect on the other), 2 mg (green, flat-faced, oblong with notched sides at double bisect and imprinted with "AMARYL" on one side and with Hoechst AG logo on both sides of the bisect on the other) and 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with "AMARYL" on one side and with Hoechst AG logo on both sides of the bisect on the other) tablets.

Janssen-Ortho Inc. and Aventis Pharma Inc. will continue to monitor worldwide pharmacovigilance reports regarding their respective products.

The current Prescribing Information for REMINYL is available on the Janssen-Ortho Inc. website at www.janssen-ortho.com. The current Prescribing Information for AMARYL® is available upon request from Aventis Pharma Inc. at 1-800-265-7927.

Reporting rates determined on the basis of spontaneously reported post-market adverse events are generally presumed to underestimate the risks associated with the drug treatments.

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of medication errors or serious and/or unexpected adverse reactions in patients receiving REMINYL or AMARYL® should be reported to the appropriate manufacturer or the Marketed Health Products Directorate at the following addresses:

Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Call toll-free at 1-800-567-3331
Or email to dsscan@joica.jnj.com
Or toll-free fax to 1-866-767-5865

or

Aventis Pharma Inc.
2150 St. Elzéar Blvd. West
Laval, Quebec
H7L 4A8
Call toll-free at 1-800-265-7927
Or toll-free fax to 1-800-268-3846

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
dsscan@joica.jnj.com

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

Your professional commitment in this regard has an important role in protecting the well-being of patients by contributing to early signal detection and informed drug use.

Should you have any questions or comments regarding the content of this letter, please contact Janssen-Ortho Inc. or Aventis Pharma Inc. by phone from 9:00 am to 5:00 pm Monday to Friday Eastern Standard Time (EST) or in writing via facsimile as follows:

Janssen-Ortho Inc.
Medical Information Department
Tel: 1-800-567-3331
Fax: 416-449-5248

Aventis Pharma Inc.
Medical Information Department
Tel: 1-800-265-7927

If you require additional information regarding the use of REMINYL* (galantamine hydrobromide) or AMARYL® (glimepiride), please contact Janssen-Ortho Inc. for REMINYL and Aventis Pharma Inc. for AMARYL®, as outlined above.

A copy of this letter is also available on the Janssen-Ortho website at http://www.janssen-ortho.com, on the Aventis website at http://www.aventispharma.ca/ and on the Health Canada website at http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/index-eng.php.

Sincerely,

original signed by

Wendy Arnott, Pharm.D.
Vice President
Regulatory, Safety & Quality
Janssen-Ortho Inc.

original signed by

Franca Mancino, M.Sc.
Director
Regulatory Affairs
Aventis Pharma Inc.

*All trademark rights used under license from Johnson & Johnson

AMARYL® is a registered trademark of Aventis Group. Used under licence by Aventis Pharma Inc., Laval, Quebec H7L 4A8.

RMDL041124B 9053

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