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

In This Article


In Table 3 , I summarize the 29 cases, rate the quality of the cases on the basis of the information provided, and then determine whether the cases fulfill the Sternbach and Hunter criteria for serotonin syndrome.

The quality of the information substantiating many of the cases is incomplete or anecdotal (such as cases 3, 4, and 16 in which pharmaceutical representatives are passing on possible incidents). Case 12, which alleges bilateral retinal detachments only, is irrelevant. Even two of the published cases, 26 and 28, leave out important information, such as vital signs or detailed neurologic exams; therefore, the Hunter criteria cannot be used.

Of the 29 cases, 7 met the Sternbach criteria but not the Hunter criteria. No cases met both criteria or the Hunter criteria only. However, even among those who met the criteria, there are some questions. The Sternbach criteria require ruling out other disorders. Information is not provided as to whether other disorders were excluded in cases 2, 6, 8, 18, 19, and 29, but I counted them as meeting the criteria. Case 28 may very well be serotonin syndrome, but the information provided is incomplete and did not meet the criteria.

Two cases met the criteria but are excluded. Case 1 met the criteria, but symptoms of hives and wheezing are not part of serotonin syndrome. The patient's physicians diagnosed conversion disorder and the symptoms later occurred off sumatriptan. Therefore, I rated case 1 as not meeting either criteria. Case 24 met the criteria, but she was noted to have had 2 prior similar episodes associated with the use of metoclopramide and naproxen for migraine. In addition, she was taking only sumatriptan and metoclopramide but was not taking an SSRI or SNRI.


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