FDA: Abilify Promotions Are Misleading Physicians and the Public


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)


    • But maybe this means the FDA is finally starting to understand that the “chemical imbalance” theory is invalid. And all those drug ads that espoused it were technically illegal, since false advertising is technically illegal in the United States.

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  1. Abilify Promotions Are Misleading Physicians and the Public

    They always did and only now the FDA is catching on. Perhaps Otsuka tried to cut costs by reducing the amount they were willing to spend on “education”.

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  2. Advertising to doctors is one thing, but advertising to the public is even more ridiculous. America needs to be like the rest of the world and just make public prescription drug advertising illegal.

    But sadly big pharma already has its money deep into our law system to make sure that most likely never happens.

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  3. Well I got connned by the “chemical imbalance”crap. I was fine til age 45. Then ten years on effexor?
    Result? Unemployable, loss of marriage, loss of finances, loss of career, loss of self esteem, changed character, loss of every damn thing…… and trying to kick the habit? Walking thru hell now for 5 months, so, so ill, never ever been so damn ill in my life, and desperate to reinstate? But it dont damn work. These drugs have killed me…….

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    • I was struck by your post because the same thing happened to me on that damned Effexor. Truly an insidious drug if there ever was one. But, and I know that we are all different so I can’t totally assure you that everything will work fine for you, but I did manage to get off the toxic stuff.

      So, what I want to say to you is DO NOT GIVE UP HOPE! No matter how terrible you feel don’t give up! Do whatever you have to do but keep going and don’t give up! I know this is so easy for me to say on this side of everything but I want you to know that I made it and others have made it and here’s hoping that you will make it! Keep going and do not give up hope! My thoughts are with you on this. Hang in there.

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    • Your brief comment accurately depicts the insidious, life-destroying effects and consequences that taking these toxins has resulted in for countless, anonymous victims, including myself! It’s my understanding that things usually get better, but it takes time. I’ll try to post much more on this when I’m up to it, and I hope others will please do the same.

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  4. … and the severe punishment including fines in the sum of all profits plus overhead and criminal charges against people responsible… not on the radar.
    Juts like the bankers. Corporate state is running wild and now TPP/TTIP are coming to take the rest of power away from the people.

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