Healthy Skepticism Library item: 1989

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Publication type: media release

Young T.
Medication Errors Involving Reminyl* and Amaryl
Janssen-Ortho Inc. & Aventis Pharma Inc.. 2004 Dec 17

Keywords:
Reminyl Amaryl

Notes:

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.

Full text:

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:

Medication errors resulting from confusion between REMINYL* and AMARYL®

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.

Terence H. Young
Chair, Drug Safety Canada
Suite 100 2030 Merchants Gate
Oakville Ontario Canada
L6M 2Z8 905 842-5910