The US Food and Drug Administration has requested that the drug manufacturer Otsuka “immediately cease” distributing some of its educational materials for its top-selling antipsychotic Abilify. Otsuka’s “pharmacology aid” documents suggest that Abilify helps modulate serotonin and dopamine levels in the brain, which the FDA called “misleading.”
The pharmacology aid states that Abilify “modulates both synaptic dopamine and serotonin,” and describes the drug’s method of action alongside depictions of light dimmer switches set to various levels.
“The totality of these claims and presentations misleadingly implies a greater degree of certainty about the mechanism of action of Abilify in humans than is currently known,” stated the FDA letter.
As far back as 2006 in PLOS Medicine, MIA Bloggers Jeffrey Lacasse and Jonathan Leo were criticizing Abilify advertising for similarly stating that the drug worked “like a thermostat to restore balance” of brain chemicals.
FDA takes aim at Abilify marketing material (Medical Marketing and Media, April 29, 2015)
FDA Letter to Otsuka Pharmaceutical Development & Commercialization, Inc (FDA, April 17, 2015)
Lacasse, Jeffrey R, and Jonathan Leo. “Questionable Advertising of Psychotropic Medications and Disease Mongering.” PLoS Med 3, no. 7 (July 25, 2006): e321. doi:10.1371/journal.pmed.0030321. (Full text)