Require Postmarket Studies, Registry for Some Anti-Depressants: Petition

The Antidepressant Coalition for Education is petitioning FDA to require postmarketing studies and a national patient registry for selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI). The petition says the patient registry should prospectively follow patients during and after SSRI or SNRI tapering or discontinuation and should prespecify separate analyses for SSRIs and SNRIs.

“The registry and related postmarketing studies should evaluate the incidence, severity, duration, and predictors of withdrawal, compare tapering strategies, assess patients’ ability to reduce dose or fully discontinue, and collect standardized patient-reported outcomes and data on serious withdrawal- or discontinuation-related events,” the petition says. “Outcomes should include akathisia and related activation symptoms, self-harm and suicide-related outcomes, persistent sexual symptoms after discontinuation, functional impairment, and longer-term patient-centered outcomes.”

The petition says antidepressant withdrawal and discontinuation difficulties can present as diverse physical, cognitive, emotional, neurologic, sensory, sleep-impairing, and sexual symptoms that may emerge during dose reduction or persist after discontinuation. It says patients have reported delayed onset after a symptom-free interval, including weeks or months later. For some patients, the symptoms may interfere with work, school, parenting, caregiving, relationships, mobility, and the ability to continue tapering or remain discontinued, according to the petition. Symptoms may fluctuate, change, or intensify as dose reductions accumulate over the course of a taper. Some patients, particularly long-term users, report greater difficulty at lower doses, the advocacy group says.