Gainesville, FL—In 2006, the FDA warned about the risk of serotonin syndrome associated with use of selective serotonin reuptake inhibitors (SSRI) or selective norepinephrine reuptake inhibitor (SNRI) antidepressants concomitantly with triptan antimigraine drugs.

A new study published in JAMA Neurology looks at how the concurrent use of the drugs changed after the FDA’s advisory, but also suggests that serotonin syndrome was so rare that the warning should be reconsidered.

Serotonin syndrome can cause tachycardia, unstable blood pressure, hyperthermia, nausea, vomiting, and diarrhea, and, in extreme cases, can be fatal.

The University of Florida College of Medicine–led data-registry study of 47,968 patients prescribed triptans determined that the proportion of patients who were coprescribed the drugs ranged from 21% to 29%, changing little after the warning. Researchers also found that the incidence of serotonin syndrome was 0 to 4 cases per 10,000 person-years of exposure to coprescription of triptans and SSRI or SNRI antidepressants.

As a result, study authors suggested, “Those with coexisting affective disorders and migraine need not forgo management of one condition to treat the other.”

To reach their conclusions, researchers used electronic health record data from the Research Patient Data Registry to identify patients who had received an International Classification of Diseases, Ninth Revision diagnosis compatible with serotonin syndrome who had been coprescribed triptans and SSRI or SNRI antidepressants. The records were from the Boston area from January 1, 2001, through December 31, 2014, with data analysis occurring in 2016 and 2017.

“The risk of serotonin syndrome associated with concomitant use of triptans and SSRIs or SNRIs was low,” study authors write. “Co-prescription of these drugs is common and did not decrease after the 2006 FDA advisory. Our results cast doubt on the validity of the FDA advisory and suggest that it should be reconsidered.”

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