FDA Warns Against Use of Migraine Drugs With Certain Antidepressants

Yael Waknine

Disclosures

July 20, 2006

July 20, 2006 — The US Food and Drug Administration (FDA) has warned healthcare professionals regarding the risk for life-threatening serotonin syndrome associated with use of 5-hydroxytryptamine receptor agonists (triptans) in conjunction with selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephrine reuptake inhibitors (SNRIs).

Coadministration of these drugs has an additive effect on serotonin levels that can lead to serotonin syndrome, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program. Symptoms may include restlessness, hallucinations, loss of coordination, tachycardia, rapid blood pressure changes, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.

Healthcare professionals prescribing a triptan, SSRI, or SNRI are advised to consider that triptans are often used intermittently, and that drugs from all 3 classes may be prescribed by different clinicians; the potential risk for serotonin syndrome should be weighed against the potential benefit of using a triptan with an SSRI or SNRI.

SSRI- or SNRI-treated patients receiving triptans should be followed closely, particularly during initiation of therapy, dose increases, or the addition of another serotonergic drug.

Patients receiving combination therapy should be made aware of the risk for serotonin syndrome and advised to seek immediate medical attention for associated symptoms.
The FDA has requested that safety labeling for triptans, SSRIs, and SNRIs be changed to reflect the potential for this additive reaction.

Triptans are used to treat migraines, and the class includes drugs such as naratriptan HCl (Amerge, made by GlaxoSmithKline); almotriptan malate (Axert, made by Ortho-McNeil Pharmaceutical, Inc); frovatriptan succinate (Frova, made by Endo Pharmaceuticals); sumatriptan/sumatriptan succinate (Imitrex, made by GlaxoSmithKline); rizatriptan benzoate (Maxalt and Maxalt-MLT, made by Merck and Company, Inc); eletriptan HBr (Relpax, made by Pfizer, Inc); and zolmitriptan (Zomig and Zomig ZMT, made by AstraZeneca Pharmaceuticals LP).

SSRIs and SNRIs are used to treat depression and other mood disorders.

SSRIs include citalopram HBr (Celexa, made by Forest Laboratories, Inc); fluvoxamine (previously marketed as Luvox by Solvay Pharmaceuticals, Inc, and now available in generic formulations); escitalopram oxalate (Lexapro, made by Forest Laboratories, Inc); paroxetine HCl (Paxil, made by GlaxoSmithKline); fluoxetine HCl (Prozac, made by Eli Lilly and Company); olanzapine/fluoxetine (Symbyax, made by Eli Lilly); and sertraline HCl (Zoloft, made by Pfizer, Inc). SNRIs include duloxetine HCl (Cymbalta, made by Eli Lilly) and venlafaxine HCl (Effexor, made by Wyeth Pharmaceuticals Inc).

Healthcare professionals are encouraged to report adverse events related to use of triptans in conjunction with SSRIs or SNRIs to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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