Withdrawal symptoms are experienced by nearly half of the people trying to quit antidepressants, even if tapered over several weeks, research finds. CCHR says prescribing information and medication guides do not adequately convey this widespread risk and calls on FDA to require updates.
by CCHR National Affairs Office
Close to half of the people who quit antidepressants experience withdrawal symptoms regardless of whether they stop suddenly or taper their dosage over several weeks, a new study finds. In light of recent research, Citizens Commission on Human Rights (CCHR) calls on the U.S. Food and Drug Administration (FDA) to require antidepressant manufacturers to carry more adequate warnings in their prescribing information and medication guides on the risk of withdrawal symptoms when patients stop using the drugs.
The new research, published in Molecular Psychiatry, investigated the incidence of so-called antidepressant withdrawal syndrome by reviewing drug trials of antidepressants that included data on withdrawal symptoms. What researchers found is that nearly half of study participants experienced withdrawal symptoms when stopping antidepressants after having used the drugs for 8 to 12 weeks in the trials.
“The pooled incidence of AWS [antidepressant withdrawal syndrome] from all available studies was 42.9% [and] from 11 RCTs [randomized controlled trials] was 44.4%,” the researchers concluded. They found no significant difference in the incidence between the types of antidepressants used.
They also found that the longer antidepressants were used, the greater the incidence of withdrawal symptoms, with the incidence rising to over 51% for those who quit after taking antidepressants for longer than 24 weeks.
These findings are consistent with prior research. One study found that more than half (56%) of people who attempt to come off antidepressants experience withdrawal effects, with nearly half (46%) of them describing the symptoms as severe. Another found that among people whose withdrawal effects were persistent, ranging in duration from 5 to 166 months, 81% experienced mental health disturbances like anxiety, depression, emerging suicidality and agitation. Physical symptoms, primarily headache, fatigue, dizziness, brain zaps, visual changes, muscle aches, tremor, diarrhea, and nausea, were experienced by 75%.
CCHR has previously called for updated warnings in prescribing information and medication guides to more adequately warn prescribers and consumers of the increased risks of atrial fibrillation, stroke, cardiovascular disease, and long-lasting and permanent sexual dysfunction from the use of antidepressants.
CCHR has also called on the FDA to issue an updated Drug Safety Communication on the risks to newborns from their mothers’ continued use of antidepressants during pregnancy. Those risks include premature birth, lower birth weight, neonatal hospitalization and withdrawal symptoms.
“The FDA, which is responsible for ensuring pharmaceutical drugs are safe, must take immediate action due to the growing body of research indicating that adverse effects when using or attempting to stop using antidepressants are more widely experienced and potentially more severe than current prescribing information and medication guides indicate,” said Anne Goedeke, president of the CCHR National Affairs Office. “FDA action is long overdue on this urgent public health issue.”
WARNING: Anyone wishing to discontinue or change the dose of an antidepressant or other psychiatric drug is cautioned to do so only under the supervision of a physician because of potentially dangerous withdrawal symptoms or other complications.