One of the top-selling prescription drugs in the world has been linked to some dangerous pathological behaviors, and now the U.S. Food and Drug Administration (FDA) is warning Americans that it could lead to uncontrollable sexual activity, binge-eating, and even gambling debts.
File this under strange-but-true: Abilify®, an antipsychotic drug produced by Japan’s Otsuka Pharmaceuticals, has been demonstrated to cause uncontrollable impulses in some patients, including heightened urges to eat, shop, have sex, and gamble. Now evidence is emerging that very little is actually known about the drug, and yet manufacturers have been peddling it since 2002.
Last Fall, Canadian regulators moved to impose new labels on Abilify, which is known by the generic name aripiprazole, to warn consumers about its unusual side-effects — but both Otsuka and the FDA failed do the same. This week, however, the FDA took the right step, by issuing a public warning about these side-effects.
A History of Gambling
Drug makers are required to list all possible side-effects on their labels and in their advertising, but the peculiar side-effects revealed in a 2014 study have been all but absent from Abilify’s marketing and promotional materials.
That study revealed how patients with no history of compulsive behavior began showing signs of binge eating, excessive spending, hyper-sexuality, and compulsive gambling while on Abilify. The urges were reported to have completely stopped once the patients came off the drug. Some of those patients were reported to have lost tens of thousands of dollars in gambling losses.
This particular study was published in March of 2014, but it wasn’t until November of last year that Canadian regulators began requiring the makers of Abilify to warn Canadian consumers about these risks. At that time in the U.S., these dangerous side-effects remained unlabeled and undisclosed.
That was, until Tuesday, when the FDA issued a warning about Abilify’s side-effects, and announced it will begin labeling all aripiprazole products with the appropriate label. In its research, the agency identified a total of 167 cases in the U.S. involving impulse-control problems in both adults and children taking Abilify. The vast majority of those cases (164) were defined by compulsive gambling.
As distressing as these side-effects are, they paint only a partial picture of the damage they can cause families and the public at-large. Excessive gambling will almost always lead to debt problems; excessive eating will generally lead to weight gain and health problems; and hyper-sexuality will usually increase the risk of sexually transmitted diseases. It is not just Abilify patients who are impacted by these side-effects, but often families, too, are devastated.
What’s perhaps worse is the fact that it has taken years for Otsuka Pharmaceuticals to warn patients about them is pretty inexcusable.
A Mysterious Little Anti-Psychotic
The FDA first approved aripiprazole back in 2002 to treat a range of mental disorders, including schizophrenia, bipolar disorder, Tourette syndrome, and autism. Today, millions of Abilify prescriptions are filed each month, and sales for aripiprazole as a whole are higher than all other major antidepressants combined.
Last year, Otsuka posted revenues north of $8 Billion, making it one of the most widely consumed antipsychotic drugs in the world. But despite enormous sales, there remains a lot about this drug that’s simply unknown — too much, many would argue.
The Daily Beast reported in 2014 that the FDA knows virtually nothing about how Abilify works, likening it to a “bazooka to conventional anti-depressants’ revolver.” Even the official Abilify product insert states: “The mechanism of action of aripiprazole… is unknown.”
Interestingly, Otsuka isn’t the first pharmaceutical company to come up against this problem. Last year, Pfizer agreed to settle a class-action lawsuit brought against it for nearly identical reasons. Plaintiffs claimed the pharmaceutical giant did not adequately warn patients about impulse control issues associated with its Parkinson’s drugs, Cabaser® and Dostinex®. One of those patients even claimed the medication turned him into a "pathological gambler” who gambled away $3 Million.
If Pfizer went down this path in 2015, why hasn’t Otsuka taken steps to warn its own customers about these very same problems? It remains to be seen how much the company knew about Abilify’s side-effects when it began marketing the drug, but it’s clear that it at least should have addressed the issue when the first study on it was published in early 2014.
Those who have been negatively affected by this drug and have seen losses due to gambling are strongly encouraged to seek legal counsel.