Practitioners' Reporting News

Reminyl® Renamed to Razadyne™

Issued May 31, 2005

Due to confusion between Ortho-McNeil's Reminyl (indicated for Alzheimer's disease) and Sanofi-Aventis' Amaryl® (indicated for diabetes), Ortho-McNeil will now market Reminyl under the new trade name Razadyne. In addition, the extended release formulation (approved in December 2004) will be marketed as Razadyne ER. The immediate release formulation, Razadyne, will be available in pharmacies beginning July 2005, and the extended release formulation, Razadyne ER, will be available mid-May 2005.

Based on reports submitted to the Food and Drug Administration (FDA) and USP, prescriptions for Reminyl have been incorrectly written, interpreted, labeled or filled, leading to confusion between Reminyl and Amaryl. Consequently, the administration of Amaryl to Alzheimer's patients, who did not have diabetes resulted in serious events, including severe hypoglycemia and—in two cases—death.

The following are summaries of reports submitted to USP's medication error reporting programs—the USP Medication Errors Reporting (MER) Program and MEDMARX®.

Case 1
During review of transfer orders, a pharmacist noticed that a patient had been receiving Amaryl instead of Reminyl for four days. Upon admission, the patient was already in a hypoglycemic state and after receiving the Amaryl became severely hypoglycemic. Fortunately, the patient returned to normal with no permanent harm. It was discovered that the physician's order was illegible and the order was mistaken for Amaryl. The medication administration record (MAR) stated Reminyl, but the nurses did not notice that the drug name on the medication label dispensed was Amaryl.

Case 2
A pharmacist received orders for an elderly woman being admitted from a nursing home with chest pains. The pharmacist entered the order for Reminyl into the computer as Amaryl, while the nurse transcribed the order to the MAR correctly. Later that evening, a nurse removed Amaryl from an automated dispensing device, assuming it was the same as Reminyl. A second nurse the next morning administered a dose of Amaryl, making the same mistake as the previous nurse. It wasn't until the third dose was being prepared for administration that a nurse recognized the discrepancy and notified the pharmacist that the patient was not diabetic and should not be on Amaryl. It turns out that Reminyl was not on the pharmacy's formulary and the pharmacist was not familiar with the medication. The pharmacist canceled the order and advised the nurse to contact the physician for clarification. In the meantime, the patient was found unresponsive but after receiving appropriate treatment suffered no permanent harm.

Case 3
A prescription was presented to the pharmacy written as "Ramiryl." The pharmacist interpreted the prescription as Amaryl. A week later, the patient's husband returned to the pharmacy and informed the pharmacist that the medication was incorrect. The original prescription was examined again and it was determined that the physician had intended to write for Reminyl. Unfortunately, as a result of this error, the patient was hospitalized for hypoglycemia for three days.

Case 4
A pharmacy dispensed Amaryl instead of Reminyl in error. As a result, the patient experienced a serious hypoglycemic episode requiring CPR. It was discovered that the order was entered into the computer correctly as Reminyl, but that Amaryl was dispensed in error. It is believed that Amaryl was refilled in the Reminyl bin and that the dispensing error was not caught by the pharmacist.

In an attempt to inform health care professionals, patients, and caregivers about the product name change of Reminyl to Razadyne, Ortho-McNeil will continue its comprehensive communications campaign, which features a variety of elements including:

Letters to healthcare professionals
Journal advertising
Pharmacist education
Outreach to professional medical societies and disease-related consumer advocacy organizations
Brochures for caregivers of patients with Alzheimer's disease

By identifying and reporting actual and potential medication errors to the MER Program, healthcare professionals are notifying three expert organizations (USP, the Institute for Safe Medication Practices, and the FDA) as well as the manufacturers and/or labelers of the product. As illustrated in the cases described above, manufacturers are then able to implement changes to their products that will possibly prevent or reduce medication errors from occurring.

If you have similar cases to share, report them to the MER Program via a secure online form or by calling 1-800-23-ERROR (1-800-233-7767) to request a reporting form.

Readers are advised that official USP cautions and warnings for drugs appear in the USP–NF or USP DI. Unless otherwise indicated, any advice or opinions expressed herein reflect solely the judgment of USP staff. Such statements are intended for further consideration and evaluation and may or may not be applicable to a particular practice. The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices.