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Warning of Dispensing Error Using Serzone (nefazodone)
This is a letter from the manufacturer to the FDA
December 9, 2002
IMMEDIATE ATTENTION REQUIRED
DISPENSING ERROR ALERT
Dear Health Care Provider,
Bristol-Myers Squibb and AstraZeneca have received reports of
prescription dispensing errors involving SERZONE® (nefazodone HCl)
Tablets and SEROQUEL® (quetiapine fumarate) Tablets.
According to the medication error reports, verbal and written
prescriptions were incorrectly interpreted, labeled, and/or filled due
to the similar names between SERZONE and SEROQUEL.
Furthermore, the overlapping strengths (100 mg and 200 mg), the dosage
form (tablets), the dosing interval (BID), and the fact that these two
products are stocked close together in pharmacies were also critical
in causing medication errors. Additionally, both drugs are generally
titrated in similar increments to overlapping target ranges (see
prescribing information).
The error reports involve dispensing SERZONE Tablets when
SEROQUEL Tablets were prescribed and the reverse scenario.
Patients erroneously receiving either medication would be inadequately
treated; control of schizophrenia symptoms may deteriorate in patients
erroneously receiving SERZONE, while depression may worsen in
patients inappropriately receiving SEROQUEL. In addition,
patients may be placed at risk for adverse events.
SERZONE is an antidepressant drug marketed as
hexagonal tablets imprinted with “BMS” and the strength on
one side and the identification code number on the other. The 100 mg
(white) and 150 mg (peach) tablets are bisect scored on both tablet
faces; the 50 mg (light pink), 200 mg (light yellow), and 250 mg
(white) tablets are not scored.
SEROQUEL is an antipsychotic drug marketed as round,
biconvex film coated tablets identified with “SEROQUEL” and the
strength on one side and plain on the other. The 25 mg tablets are
peach-colored, the 100 mg tablets are yellow, and the 200 mg tablets
are white.
Bristol-Myers Squibb has developed a patient-information leaflet
about SERZONE, which is being given to patients when
prescriptions are filled. These leaflets will facilitate communication
between you and your patients and help ensure that patients receive
the correct medication. Please encourage your patients to make sure
that the medication dispensed by the pharmacist matches the SERZONE
picture card enclosed with this letter and the description of
SERZONE tablets in the patient-information leaflet. Also,
encourage your patients to be certain that the tablets they receive
are imprinted with “BMS”.
Additionally, certain packaging changes to both products have been
implemented that highlight the endings of the product names. The
revised SERZONE (nefazodone HCl) logo appears at the end of
this letter. This should assist the dispenser in distinguishing the
products.
Recommended actions to help prevent dispensing errors
If you become aware of a prescription dispensing error involving
SERZONE or SEROQUEL,
please contact one of the following:
- USP Medication Errors Reporting Program (1-800-233-7767 or
www.usp.org)
- Institute for Safe Medicines Practice (www.ismp.org)
- FDA MEDWATCH program (phone 1-800-FDA-1088, FAX 1-800-FDA-0178,
Internet:
www.fda.gov/medwatch or www.fda.gov/medwatch, or mail: FDA Safety
Information and Adverse Event Reporting Program, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20852-9787)
- Bristol-Myers Squibb Company at 1 (609) 818-3737 [SERZONE]
- AstraZeneca at 1 (800) 236-9933 [SEROQUEL]
For additional information please contact:
- Bristol-Myers Squibb Drug Information Department at 1 (800)
321-1335
- AstraZeneca Information Center at 1 (800) 236-9933
Thank you.
Sincerely,
Darlene Jody, M.D.
Vice President Global Medical Marketing
Bristol-Myers Squibb Company
PLEASE CONSULT THE ENCLOSED COMPLETE PRESCRIBING INFORMATION FOR
SERZONE, INCLUDING BOXED WARNING REGARDING HEPATOTOXICITY.
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