FDA

FDA Advisory on Concomitant Migraine, Depression Meds Questioned

Concomitant use of triptans and selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs) is associated with a low risk of serotonin syndrome, according to the results of a new study.

These findings cast doubt onto a 2006 advisory from the US Food and Drug Administration (FDA) warning of the risk of serotonin syndrome with concomitant use of the drugs.
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For their study, the researchers assessed electronic health record data on patients who had been coprescribed triptans and SSRI or SNRI antidepressants and had received a diagnosis compatible with serotonin syndrome.

Risk was assessed using both conservative and broad case definitions in order to better characterize the spectrum of risk.

The researchers identified 47,968 unique patients who were prescribed triptans and 19,017 patients who were coprescribed triptans and antidepressants (30,928 person-years of exposure).

Ultimately, 17 patients had suspected serotonin syndrome. Only 2 patients were classified as having definite serotonin syndrome (incidence rate 0.6 per 10,000 person-years of exposure), and 5 were classified as having possible serotonin syndrome (incidence rate [with these 5 cases added to the 2 definite cases] 2.3 cases per 10,000 person-years of exposure).

The researchers noted that the proportion of patients with concomitant triptan and SSRI/SNRI antidepressant prescriptions were relatively stable during the study (21% to 29%).

“The risk of serotonin syndrome associated with concomitant use of triptans and SSRIs or SNRIs was low,” the researchers concluded. “Coprescription 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.”

—Christina Vogt

Reference:

Orlova Y, Rizzoli P, Loder E. Association of coprescription of triptan antimigraine drugs and selective serotonin reuptake inhibitor or selective norepinephrine reuptake inhibitor antidepressants with serotonin syndrome [Published online February 26, 2018]. JAMA Neurol. doi:10.1001/jamaneurol.2017.5144.