Janssen Pharmaceutica has agreed to change the name of its Alzheimer's drug Reminyl in response to inadvertent dispensing of the oral blood glucose-lowering drug Amaryl in its place. The mix-ups have resulted in cases of severe hypoglycemia and other serious adverse events, including one fatality.
In a Dec. 22, 2004, letter, the Food and Drug Administration acknowledged Janssen's intention to change the name of all Reminyl products.
At press time, the new name had not been announced.
Amaryl is the trade name for glimepiride, which is approved for treating type 2 diabetes and is marketed by Aventis. Reminyl has been the trade name for galantamine, which is approved for mild to moderate dementia of the Alzheimer's type and is marketed by Janssen Pharmaceutica.
Spontaneous reports submitted to the FDA and to the U.S. Pharmacopeia have described prescriptions that have been “incorrectly written, interpreted, labeled, and/or filled due to the similarity” between the two trade names, according to a “Dear Health Care Provider” letter issued by Janssen. The letter was posted on the FDA's MedWatch Web site (www.fda.gov/medwatch
Making the confusion more likely is that both drugs come in 4-mg strengths and in tablet formulations. And because both generic names start with the letter g, the drugs may be stored near each other.
The starting dose of Reminyl is 4 mg twice a day, while the starting dose of Amaryl is 1-2 mg twice a day, with a maximal starting dosage of 2 mg, the letter states.
Health care professionals who become aware of these or any other medication errors should call the USP Medication Errors Reporting Program, at 800-23ERROR or 800-FAIL-SAF; or the FDA's MedWatch Adverse Event Reporting Program at 800-FDA-1088.
Errors also can be reported to the manufacturers: 800-526-7736 (Janssen) or 800-633-1610 (Aventis).