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Pharmacist -
Wyeth wishes to inform you about important safety information that
the U.S. Food and Drug Administration (FDA) has asked the
manufacturers of ten antidepressants, including Effexor (venllafaxine
HCI) and Effexor XR (venlafaxine HCI), to include in their product information.
The Effexor XR
prescribing information was amended as follows (the prescribing
information for Effexor was similarly updated):
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Under WARNINGS
section:
Clinical
Worsening and Suicide Risk
Patients with
major depressive disorder, both adult and pediatric, may experience
worsening of their depression and/or the emergence of suicidal
ideation and behavior (suicidality), whether or not they are taking
antidepressant medication, and this risk may persist until
significant remission occurs. Although there has been a
long-standing concern that antidepressants may have a role including
worsening of depression and the emergence of suicidality in certain
patients, a causal role for antidepressants in inducing such
behaviors has not been established. Nevertheless,
patients being treated with antidepressants should be observed
closely for clinical worsening and suicidality, especially at the
beginning of a course of drug therapy, or at the time of dose
changes, either increasing or decreases. Consideration
should be given to changing the therapeutic regimen, including
possibly discontinuing the medication, in patients whose depression
is persistently worse or whose emergent suicidality is sever, abrupt
in onset or was not part of the patient's presenting symptoms.
Because of the
possibility of the co-morbidity between major depressive
disorder and other psychiatric and nonpsychiatric disorders, the same
precautions observed when treating patients with major depressive
disorder should be observed when treating patients with other
psychiatric and nonpsychiatric disorders.
The following
symptoms, anxiety, agitation, panic attacks, insomnia, hostility
(aggressiveness), impulsivity, akathisia (psychomotor restlessness),
hypomania, and mania have been reported in adult and pediatric
patients being treated with antidepressants for major depressive
disorder as well as for other indications, both psychiatric and
nonpsychiatric. Although a causal link between the emergence of
such symptoms and either the worsening of depression and/or the
emergence of suicidal impulses has not been established,
consideration should be given to changing the therapeutic regimen,
including possibly discontinuing the medication, in patients for whom
such symptoms are severe, abrupt in onset, or were not part of the
patient's presenting symptoms.
Families
and caregivers of patients being treated with
antidepressants for major
depressive disorder or other indications, both psychiatric and
nonpsychiatric, should be alerted about the need to monitor patients
for the emergence of agitation, irritability, and ther other
symptoms described above, as well as the emergence of suicidality,
and to report such symptoms immediately to health care
providers. Prescriptions
for Effexor XR should be written for the smallest quantity of
capsules consistent with good patient management, in order to reduce
the risk of overdose.
If the
decision has been made to discontinue treatment, medication should be
tapered, as rapidly as is feasible, but with recognition that abrupt
discontinuation can be associated with certain symptoms (see PRECAUTIONS
and DOSAGE AND ADMINISTRATION.
Discontinuing Effexor XR,
for a description of the risks of discontinuation of Effexor XR).
It should be
noted that Effexor XR is not approved for use in treating any
indications in the pediatric population.
A major
depressive episode may be the initial presentation of bipolar
disorder. It is generally believed (though not established in
controlled trials) that treating such an episode with an
antidepressant alone may increase the likelihood of precipitation of
a mixed/manic episode in patients at risk for bipolar disorder.
Whether any of the symptoms described above represent such a
conversion is unknown. However, prior to initiating treatment
with an antidepressant, patients should be adequately screened to
determine if they are at risk for bipolar disorder; such screening
should include a detailed psychiatric history, including a family
history of suicide, bipolar disorder, and depression. It should
be noted that Effexor XR is not approved for use in treating bipolar depression.
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Under ther PRECAUTIONS
section, General
subsection:
Discontinuation
of Treatment with Effexor XR
Discontinuation
symptoms have been systematically evaluated in patients taking
venlafaxine to include prospective analyses of clinical trials in
Generalized Anxiety Disorder and retrospective surverys of trials in
major depressive disorder. ABrupt discontinuation or dose
reduction of venlafaxine at various doses has been found to be
associated with the appearance of new symptoms, the frequency of
which increased with increased dose level and with longer duration of
treatment. Reported symptoms include agitation, anorexia,
anxiety, confusion, coordintation impaired, diarrhea, dizziness, dry
mouth, dysphoric mood, fasciculation, fatigue, headaches, hypomania,
insomnia, nausea, nervousness, nightmares, sensory disturbances
(including shock-like electrical sensations), somnolence, sweating,
tremor, vertigo, and vomiting.
During
marketing of Effexor XR, other SNRIs (Serotonin an Norepincphrinc
Reuptake Inhibitors), and SSRIs( Selective Serotonin Reuptake
Inhibitors), there have been spontaneous reports of adverse events
occuring upon discontinuation of these drugs, particularly when
abrupt, including the following: dysphoric mood, irritability,
agitation, dizziness, sensory disturbances (e.g paresthesias such as
electric shock sensations), anxiety, confusion, headache, lethargy,
emotional lability, insomnia, hypermonia, tinnitus, and
seizures. While these events are generally self-limiting, there
have been reports of serious discontinuation symptoms.
Patients
should be monitored for these symptoms when discontinuing treatment
with Effexor XR. A gradual reduction in the dose rather than
abrupt cessation is recommended whenever possible. If
intolerable symptoms occur following a decrease in the dose or upon
discontinuation of treatment, then resuming the previously prescribed
dose may be considered. Subsequently, the physician may
continue decreasing the dose but at a more gradual rate (see DOSAGE
AND ADMINISTRATION).
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Under the PRECAUTIONS
section,
Information
for Patients subsection:
Patients and
their families should be encouraged to be alert to the emergence of
anxiety, agitation, panic attacks, insomnia, irritability, hostility,
impulsivity, akathisia, hypomania, mania, worsening of depression,
and suicidal ideation, especially early during antidepressant
treatment. Such symptoms should be reported to the patient's
physician, especially if they are severe, abrupt in onset, or were
not part of the patient's presenting symptoms.
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Under the PRECAUTIONS
section, Pregnancy subsection:
Non-teratogenic
Effects
Neonates
exposed to Effexor XR, other SNRIs (Serotonin and Norepinephrine
Renptake Inhibitors), or SSRIs( Selective Serotonin Reuptake
Inhibitors), late in the third trimester have developed complications
requiring prolonged hospitalization respiratory support and tube
feeding. Such complications can arise immediately upon
delivery. Reported clinical findings have included respiratory
distress, cyanosis, apnea, seizures, temperature instability, feeding
difficulty, vomiting, hypoglycemia, hypotonia, hypertonia,
hyperreflexia, tremor, jitterriness, irritability and constant
crying. These features are consistent with either a direct
toxic effect of SSRIs and SNRIs or possibly a drug discontinuation
syndrome. It should be noted that in some cases, the clinical
picture is consistent with serotonin syndrome (see PRECAUTION-Drug Interactions-CNS-Active
Drugs).
When treating a pregnant woman with Effexor XR during the third
trimester, the physician should carefully consider the potential
risks and benefits of treatment (see DOSAGE AND
ADMINISTRATION).
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Under the DOSAGE
AND ADMINISTRATION section, Special Populations subsection:
Treatment
of Pregnant Women During
the Third Trimester
Neonates
exposed to Effexor XR, other SNRIs, or SSRIs, late in the third
trimester have developed complications requiring prolonged
hospitalization, respiratory support, and tube feeding (see PRECAUTIONS).
When treating pregnant women with Effexor XR during the third
trimester, the physician should carefully consider the potential
risks ad benefits of treatment. The physicia may consider
taperin Effexor XR in the third trimester.
There are also
revisions to the PRECAUTIONS section, General
subsection
(Changes i Weight, Changes
in Height, and Changes in Appetitie),
and Pediatric Use subsection, based on clinical trial
information. We strongly recommend that you review the attached
prescribing infomation for Effexor and Effexor XR.
Wyeth is
committed to global surveillance of all its products and to providing
you with current product infomation and therefore is informing you
about this update. Should you have any questions or wish to
report any adverse even assocaited with Effexor and Effexor XR,
please call Wyeth at 1-800-934-5556. In addition, you can send
adverse event information directly to Wyeth Global Safety
Surveillance and Epidermiology (GSSE) by fax to 610-989-5544 or by
mail to GSSE, 500 Areola Road, Collegeville, PA 19426.
Adverse event
information may also be reported to the FDA's MedWatch Reporting
System by phone (1-800-FDA-1088), faz (1-800-FDA-0178), via the
MedWatch Web sute at www.fda.gov/medwatch,
or by mail (using postage paid form) to MedWatch, OF-2, 5600
Fisher's Lane, Rockville, MD 20852-9787.
Source: Wyeth |
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