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-17000805

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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 Health Care Professional:

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.
• Physicians have a pivotal role in helping to avoid such errors. The following suggestions are offered:
• For phone prescriptions, spell out the name of the medication.
• For written prescriptions, print the name of the medication clearly.

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 physician's role in avoiding such errors is pivotal. Your assistance is requested in clearly communicating 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:

• For phone prescriptions, spell out the name of the medication.
• For written prescriptions, print the name of the medication clearly.

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, OntarioM3C 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

cadrmp@hc-sc.gc.ca

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 your 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. Aventis Pharma Inc.

Medical Information Department Medical Information Department

Tel: 1-800-567-3331 Tel: 1-800-265-7927

Fax: 416-449-5248

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 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.

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