Title: FW: FDA Droperidol Warning
Pour ceux qui se servent de Drop�ridol dans le traitement des migraines (et despatients agit�s), ce qui suit vous laissera songeur
Objet�: FW: FDA Droperidol Warning
Objet�: FW: FDA Droperidol Warning
To AAEM members,
Below is an important warning on the use of droperidol. Note that
serious complications have occurred at therapeutic dosages. Also
note the recommendation for measuring the QT interval prior to
administration and continuous cardiac monitoring. The concerns
raised over use in alcohol abuse are also to be noted by EM
physicians.
This is the retyped text of a letter from Akorn Pharmaceuticals.
Contact the company for a copy of any referenced enclosures.
IMPORTANT DRUG WARNING
December 4, 2001
Dear Health Care Professional,
Reports of deaths associated with QT prolongation and torsades de
pointes in patients treated with doses of INAPSINE (droperidol)
above, within and even below the approved range have prompted Akorn
to revise sections of the prescribing information, specifically 1)
WARNINGS (including a new Box Warning) which call attention to the
potential for serious morbidity and mortality, 2) INDICATIONS which
reinforces the appropriate patient population for whom this product
is intended, and 3) DOSAGE AND ADMINISTRATION which clarifies the
available dosing information. There have been a number of reports
of patients who have been treated with droperidol and who developed
suspected or established torsades de pointes, at times leading to
death. There have been additional cases of symptomatic arrhythmia
associated with a prolonged QT interval after droperidol
administration that have been submitted via ongoing safety
surveillance activities. In addition, clinical investigators have
reported a dose-related increase in QT prolongation with droperidol
and replication of cardiac changes in a patient rechallenged with
droperidol. Therefore, Acorn, Inc. has made important changes to the
INAPSINE label. The labeling changes will be implemented within the
next several weeks. In the meantime, we want you to be aware of this
important safety information. Listed below are highlights of
important changes to WARNINGS and INDICATIONS. You should consult
the full prescribing information accompanying this letter for all of
the changes.
The following BOX WARNING has been added:
WARNING
Cases of QT prolongation and/or torsades de pointes have been
reported in patients receiving INAPSINE at doses at or below
recommended doses. Some cases have occurred in patients with no known
risk factors for QT prolongation and some cases have been fatal. Due
to its potential for serious proarrhythmic effects and death,
INAPSINE should be reserved for use in the treatment of patients who
fail to show an acceptable response to other adequate treatments,
either because of insufficient effectiveness or the inability to
achieve an effective dose due to intolerable adverse effects from
those drugs (see Warnings, Adverse Reactions, Contraindications, and
Precautions).
Cases of QT prolongation and serious arrhythmias (e.g., torsades de
pointes) have been reported in patients treated with INAPSINE. Based
on these reports, all patients should undergo a 12-lead ECG prior to
administration of INAPSINE to determine if a prolonged QT interval
(i.e., QTc greater than 440 msec for males or 450 msec for females)
is present. If there is a prolonged QT interval, INAPSINE should NOT
be administered. For patients in whom the potential benefit of
INAPSINE treatment is felt to outweigh the risks of potentially
serious arrhythmias, ECG monitoring should be performed prior to
treatment and continued for 2-3 hours after completing treatment to
monitor for arrhythmias.
INAPSINE is contraindicated in patients with known or suspected QT
prolongation, including patients with congenital long QT syndrome.
INAPSINE should be administered with extreme caution to patients who
may be at risk for development of prolonged QT syndrome (e.g.,
congestive heart failure, bradycardia, use of a diuretic, cardiac
hypertrophy, hypokalemia, hypomagnesemia, or administration of other
drugs known to increase the QT interval). Other risk factors may
include age over 65 years, alcohol abuse, and use of agents such as
benzodiazepines, volatile anesthetics, and IV opiates. Droperidol
should be initiated at a low dose and adjusted upward, with caution,
as needed to achieve the desired effect.
This is also reinforced in WARNINGS, as well as in CONTRAINDICATIONS.
The INDICATIONS AND USAGE section now reads:
INAPSINE (droperidol) is indicated to reduce the incidence of nausea
and vomiting associated with surgical and diagnostic procedures.
The DOSAGE AND ADMINISTRATION SECTION now reads:
Dosage should be individualized. Some of the factors to be considered
in determining the dose are age, body weight, physical status,
underlying pathological condition, use of other drugs, type of
anesthesia to be used and the surgical procedure involved.
Vital signs and ECG should be monitored routinely.
Adult dosage: The maximum recommended initial dose of INAPSINE is 2.5 mg IM or slow IV.
Additional 1.25 mg doses of INAPSINE may be
administered to achieve the desired effect. However, additional doses
should be administered with caution, and only if the potential
benefit outweighs the potential risk.
Children's dosage: For children two to 12 years of age, the maximum
recommended initial dose is 0.1 mg/kg, taking into account the
patient's age and other clinical factors. However, additional doses
should be administered with caution and only if the potential benefit
outweighs the potential risk. It is important that you forward any
adverse event information associated with the use of droperidol to
Akorn at 1-888-519-8384. You can also report this information
directly to the FDA via the MedWatch system at 1-800-FDA-1088, by
fax at 1-800-FDA-0178, by mail (using a postage-paid form), or the
internet at www.fda.gov/medwatch .
Sincerely,
Vice President, Medical Affairs and Worldwide Drug Safety
AAEM
611 East Wells Street
Milwaukee, WI 53202
800-884-2236
Fax: 414-276-3349
E-mail: [EMAIL PROTECTED]
Website: www.aaem.org
