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

Methods

In the July 19, 2006 alert, the FDA summarized the data that were the basis for the alert as follows:

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.

Specific information about the cases is not available through the FDA publication or Web site. At the end of July 2006, I submitted a Freedom of Information Act request to the FDA who provided me with their complete reports of 29 possible serotonin syndrome cases (2 more than described in the alert). Eight of the cases have been published, and the rest were submitted to the FDA through the MedWatch reporting system. The FDA did not provide me with their analysis of the cases, what criteria they used, and whether they met the criteria for serotonin syndrome.

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