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To: RxLink
From:
Janssen Pharmaceutica
October
19, 2004
Important
Safety Alert Regarding Medication Errors
Janssen
Pharmaceutica Products, L.P. and Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. have recently been made aware of
several reports of medication errors involving confusion between
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 Pharmaceuticals Inc., indicated
for the treatment of non-insulin dependent (Type 2) diabetes
mellitus. These reports include instances in which Reminyl was
prescribed but Amaryl was incorrectly dispensed and administered
instead, leading to various events including severe hypoglycemia and
one death.
According to
spontaneous reports submitted to the FDA and the United States
Pharmacopoeia, prescriptions have been incorrectly written,
interpreted, labeled, and/or filled due to the similarity in names
between Reminyl and Amaryl. 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 initially dosed at 1-2 mg ONCE a day, with a
maximum starting dosage of 2 mg.
Reminyl is
supplied for oral administration as 4 mg (round, off-white), 8 mg
(round, pink), and 12 mg (round, orange-brown) tablets. Reminyl
tablets are imprinted "Janssen" on one side, and 'G"
and the strength "4", "8", or "12" on
the other side.
Amaryl is
applied for oral administration as 1 mg (pink, flat-faced, oblong
with notched sides at double bisect and imprinted with
"Amaryl"), 2mg (green, flat-faced, oblong with notched
sides at double bisect and imprinted with "Amaryl") and 4
mg (blue, flat-faced, oblong with notched sides at double bisect,
imprinted with "Amaryl").
We recognize
that medication errors have multiple system causes and the
pharmacist's role in avoiding such errors is pivotal. Your assistance
and increased attention is requested in verifying and accurately
dispensing oral and written p[prescriptions for these two products to
help avoid future medication error.
We offer the
following suggestions to help decrease the potential for future errors:
-Place Amaryl
and Reminyl 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
-Counsel
patients about the brand name, indication and proper use of each medication.
Janssen
Pharmaceutica Products, L.P. has developed the following enclosed
material for pharmacists to help prevent further medication error.
- A 'shelf
talker" that can be used to help differentiate Reminyl form
other stocked merchandise.
If you become
aware of any medication errors involving Reminyl, report them
immediately to us at 1-800-JANSSEN (526-7736), and if Amaryl is
involved, to Aventis Pharmaceutica at 1-800-633-1610. Medication
errors should also be reported to the USP Medication Errors Reporting
Program in cooperation with the Institute for Safe Medication
Practices 1-800-23ERROR; 1-800-FAIL-SAF) or FDA's MedWatch Adverse
Event Reporting Program (1-800-FDA-1088).
Thank you for
your attention to this matter.
Ramy Mahmoud,
MD, MPH
Vice
President, CNS
Janssen Medical Affairs, LLC
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