On November 2nd, 2015, Health Canada issued a formal safety alert, warning patients and physicians about an increased risk for uncontrollable impulses that result from taking the antipsychotic medication Abilify® (aripiprazole). Labels for Abilify and Abilify Maintena have now been updated to include the risks of pathological gambling and hypersexuality. Canada’s alert and subsequent label change follows a year after a similar label change went into effect in Europe. Though a label change has yet to happen in the U.S., it’s clear that such an action is long overdue.
Statistics from the case study in the journal Current Drug Safety demonstrate that some patients using Abilify did, in fact, experience impulsive gambling as a side-effect from this drug. What’s even more frightening is that, according to the data collected in the study, none of these patients had a prior history of compulsive gambling – and all compulsive gambling habits ceased immediately once patients dropped Abilify from their regimen.
All of this is making November headlines because of Canada’s decisions to issue a health-safety alert and demand a label change, but it’s important to note that this is certainly nothing new when it comes to Abilify and its manufacturers, Otsuka Pharmaceuticals, Co.
Abilify’s Past Reveals a History of Known Dangers
In order to understand the problem here, one must dive into the history of Abilify. Otsuka Pharmaceuticals, a Tokyo-based corporation with U.S. headquarters in Princeton, NJ, put Abilify on the U.S. antidepressant market in late 2007. The drug is intended to help people with mental health issues such as: schizophrenia, bipolar disorder, and depression. Marketed predominantly as an antidepressant, and, with 2013-2014 sales totalling over $6.8 Billion, Abilify steadily remains one of America’s highest-selling drugs. And if one watches their advertisements on television, it’s easy to see why, as this is the claim their hypothetically depressed patient makes:
“Depression used to define me; but then my doctor added Abilify to my antidepressant. Now? I feel better.”
Simple as that: Take Abilify as a “stabilizer” and depression just washes away, right?
Unfortunately, as Canada’s actions and the recent studies demonstrate, it’s just not that easy. It’s hard to believe that any patient who is suffering from depression – or schizophrenia or bipolar disorder – would feel any better when they are, suddenly and unexpectedly, drowning in unforeseen gambling debts. What’s even worse is that drugmakers like Otsuka do not explicitly warn their patients that they could potentially fall victim to these known and documented pathological behaviors. And what incentive would they have – especially if such a warning results in a reduced bottom line?
The sad thing is that shortly after Abilify was approved by the FDA in 2007 to treat depression, the correlations between the drug and unintentional compulsive behaviors started cropping up almost immediately. But because the drug was selling so well, little efforts were made to draw public attention toward these negativities.
How Abilify Works & Why It Causes Dangerous Compulsive Behaviors
Because Abilify acts on the same nerves in the brain that are activated by dopamine and serotonin, both of which stimulate the brain’s pleasure centers, patients may experience decreased inhibition and feelings of invulnerability. In addition to an increased risk for compulsive gambling, researchers have also noted an increased risk of overeating, excessive spending and shopping, and hypersexuality. All of these negative side-effects are made even worse by the fact that they engender secondary problems, such as tens of thousands of dollars’ worth of debt, further health issues associated with weight-gain, and increased risks for sexually-transmitted diseases.
Because an antipsychotic drug like Abilify overloads the brain with an abundance of dopamine and serotonin, the brain can have a hard time determining when these 2 neurotransmitters are in excess. As a result, consequences of one’s actions aren’t properly foreseen and judged, and this can result in a patient who, over time, develops pathological symptoms. These pathological symptoms can be uncontrollable and impossible to stop without expert help or cessation of the medication.
What Precedent Does Canada’s Relabeling Mandate Set for the U.S.?
What the recent developments out of Canada tell us is that active measures are being taken to both monitor this drug’s usage and to draw awareness to the devastating effects that it can have on patients, and also their families and loved ones. Gambling debt doesn’t affect only the gambler – it’s a problem that can decimate a family’s savings and leave families with little options but to sell assets, take on additional debt, relocate, or perhaps even cancel some of their lifelong goals, such as saving for a new home, putting children through college, or retiring.
It’s obvious that these consumers deserved, in the very least, to be warned about the increased risk of such compulsive behaviors. Perhaps if they had been sufficiently warned, physicians and patients wouldn’t have been so apt to prescribe and take this harmful drug.
At roughly $800 dollars for a bottle of 30 Abilify tablets, the least patients deserve is a warning that this drug could lead to dangerous pathological behaviors. The label change from Canada – which follows last year’s label change in Europe – aims to remedy this issue, at least to some extent – and to hopefully spark an international trend, where other countries quickly follow suit. Let’s hope that sooner rather than later, this trend makes its way to the U.S.