The FDA Alert on Serotonin Syndrome With Combined Use of SSRIs or SNRIs and Triptans: An Analysis of the 29 Case Reports

Randolph W. Evans, MD

Disclosures
In This Article

Introduction

On July 19, 2006, the US Food and Drug Administration (FDA) issued an alert, "Potentially Life-Threatening Serotonin Syndrome With Combined Use of SSRIs or SNRIs and Triptan Medications.[1]" (An update was issued on November 24, 2006 adding sibutramine.[2]) The FDA reported that there is the potential for life-threatening serotonin syndrome in patients taking 5-hydroxytryptamine receptor agonists (triptans) and selective serotonin reuptake inhibitors (SSRIs) or SSRIs/selective norepinephrine reuptake inhibitors (SNRIs) concomitantly ( Table 1 ).

"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."[1] The FDA now requires that this information be included as part of the prescribing information for triptans.

Since then, on the basis of this alert, numerous patients and their physicians have received warnings or recommendations from pharmacists to discontinue one of their medications when they are taking these combinations (information from my practice and many other physicians with whom I have spoken). Should one of the medications be discontinued?

I review the information on the number of patients who may be taking these combinations, serotonin syndrome, and the cases that the FDA reviewed to issue this alert.

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