Drugs

SSRI/SNRI Labeling Changes Sought

Antidepressant Coalition for Education founder Morgan Stewart is petitioning FDA to make specific changes to the labeling for selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), including both branded and generic formulations. The petition specifically asks that FDA:

add a Boxed Warning to inform healthcare providers and patients about the risk of severe, protracted withdrawal symptoms, including symptoms that may persist for months or even years following cessation;
add a Warning in the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information of Prescribing Information to inform healthcare providers and patients about the risk of severe, protracted withdrawal symptoms, including symptoms that may persist for months or even years following cessation;
replace the term “discontinuation syndrome” with “withdrawal” in all Prescribing Information to better reflect the true nature and severity of withdrawal;
add a Warning to the labeling to inform that withdrawal-induced akathisia can occur upon discontinuation of SSRIs and SNRIs, and that it increases the risk of suicide;
include a detailed description of withdrawal symptoms in the Warnings and Precautions and Adverse Reactions of Prescribing Information covering the full spectrum of withdrawal effects;
include a statement in the Warnings and Precautions section clarifying that withdrawal symptoms may be misinterpreted as a relapse of the underlying condition, leading to potential misdiagnosis and inappropriate treatment adjustments; and
provide evidence-based guidelines for tapering SSRIs and SNRIs in the Prescribing Information, including recommendations for gradual dosage reduction to minimize withdrawal risks, and emphasize that abrupt discontinuation or rapid tapering can increase the severity of withdrawal symptoms.

“A growing body of research, coupled with patient testimony, demonstrates that withdrawal symptoms from these medications can persist far longer than what’s suggested by SSRI and SNRI prescribing information,” the petition says. “The failure to reflect the true extent of withdrawal leads to misdiagnosis, inappropriate treatment changes, and unnecessary suffering for patients…. The current labeling fails to meet the requirements of the Federal Food, Drug, and Cosmetic Act by not providing accurate, complete, and non-misleading information regarding the nature and duration of SSRI and SNRI withdrawal symptoms.”

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