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Information for Healthcare
Professionals
Selective Serotonin Reuptake Inhibitors (SSRIs)
Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)
5-Hydroxytryptamine Receptor Agonists (Triptans)
(list of drug
names)
FDA ALERT [7/2006]: Potentially Life-Threatening
Serotonin Syndrome with Combined Use of SSRIs or SNRIs and Triptan
Medications
There is the potential for life-threatening serotonin
syndrome (a syndrome of changes in mental status, autonomic
instability, neuromuscular abnormalities, and gastrointestinal
symptoms) in patients taking 5-hydroxytryptamine receptor agonists
(triptans) and selective serotonin reuptake inhibitors (SSRIs) or
selective serotonin/norepinephrine reuptake inhibitors (SNRIs)
concomitantly (see drug names at the bottom of this sheet). This
information is based on reports of serotonin syndrome occurring in
patients treated with triptans and SSRIs/SNRIs, and the biological
plausibility of such a reaction in persons receiving two
serotonergic medications. The FDA recommends that patients treated
concomitantly with a triptan and an SSRI/SNRI be informed of the
possibility of serotonin syndrome (which may be more likely to
occur when starting or increasing the dose of an SSRI, SNRI, or
triptan) and be carefully followed.
This information reflects
FDA’s preliminary analysis of data concerning this drug. FDA
is considering, but has not reached a final conclusion about this
information. FDA intends to update this sheet when
additional information or analyses become available.
To report any unexpected adverse or serious
events associated with the use of this drug, please contact the
FDA MedWatch program at 1-800-FDA-1088 or
http://www.fda.gov/medwatch/report/hcp.htm
Considerations
- Weigh the potential risk of concomitant SSRI/SNRI and
triptan use with the benefit expected from using each drug,
prior to prescribing these drugs together.
- When prescribing an SSRI or a triptan, physicians should
discuss the possibility of serotonin syndrome with patients if
an SSRI and a triptan will be used concomitantly. Healthcare
providers should keep in mind that triptans are often used
intermittently, and that the SSRI, SNRI, or triptan may be
prescribed by a different healthcare provider.
- Healthcare providers should be alert to the highly variable
signs and symptoms of serotonin syndrome. Serotonin syndrome
symptoms may include mental status changes (e.g., agitation,
hallucinations, coma), autonomic instability (e.g., tachycardia,
labile blood pressure, hyperthermia), neuromuscular aberrations
(e.g. hyperreflexia, incoordination) and/or gastrointestinal
symptoms (e.g., nausea, vomiting, diarrhea).
- If concomitant treatment with an SSRI or SNRI and triptan is
clinically warranted, the patient should be carefully observed,
particularly during treatment initiation and dose increases.
Data Summary
The FDA has reviewed 27 reports of serotonin syndrome reported in
association with concomitant SSRI or SNRI and triptan use. Two
reports described life-threatening events and 13 reports stated
that the patients required hospitalization. Some of the cases
occurred in patients who had previously used concomitant SSRIs or
SNRIs and triptans without experiencing serotonin syndrome. The
reported signs and symptoms of serotonin syndrome were highly
variable and included respiratory failure, coma, mania,
hallucinations, confusion, dizziness, hyperthermia, hypertension,
sweating, trembling, weakness, and ataxia. In 8 cases, recent dose
increases or addition of another serotonergic drug to an SSRI/triptan
or SNRI/triptan combination were temporally related to symptom
onset. The median time to onset subsequent to the addition of
another serotonergic drug or dose increase of a serotonergic drug
was 1 day, with a range of 10 minutes to 6 days.
Serotonin syndrome following concomitant SSRI or SNRI and triptan
use is biologically plausible. SSRIs, SNRIs, and triptans
independently increase serotonin levels. Therefore, it is expected
that concomitant use of SSRIs or SNRIs and triptans would result
in higher serotonin levels than the serotonin levels observed with
the use of SSRIs, SNRIs, or triptans alone, potentially leading to
serotonin syndrome.
SSRIs |
SNRIs |
Triptans |
- Celexa (citalopram)
- Fluvoxamine
- Lexapro (escitalopram)
- Paxil (paroxetine)
- Prozac (fluoxetine)
- Zoloft (sertraline)
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- Cymbalta (duloxetine)
- Effexor (venlafaxine)
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- Amerge (naratriptan)
- Axert (almotriptan)
- Frova (frovatriptan)
- Imitrex (sumatriptan)
- Maxalt and Maxalt-MLT (rizatriptan)
- Relpax (eletriptan
- Zomig and Zomig ZMT(zolmitriptan)
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Additional Information
http://www.fda.gov/cder/drug/antidepressants/default.htm
FDA Patient Information Sheet
http://www.fda.gov/cder/drug/infosheets/patient/paroxetinePIS.pdf
Report serious adverse events to
FDA’s MedWatch reporting system by completing a form on line at
http://www.fda.gov/medwatch/report.htm, by faxing
(1-800-FDA-0178),
by mail using the postage-paid address form provided online
(5600 Fishers Lane, Rockville, MD 20852-9787),
or by telephone (1-800-FDA-1088).
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Date created: July 19, 2006 |
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