In May, the Food and Drug Administration (FDA) warned that that the antipsychotic drug Abilify® (aripiprazole) could trigger compulsive pathological behaviors in some people who take it to treat bipolar disorder, depression, and/or schizophrenia. Although gambling is the most common, some of the other behaviors now known to be associated with Abilify include compulsive eating, shopping, and hypersexuality.
Once someone stops taking Abilify, the compulsive behavior goes away. It seems simple, except for one thing: No one is going to blame a drug for their behavior. Not unless there is warning on the label. And that is the problem.
For many years, Otsuka, the drug’s manufacturer, sold Abilify without warning that the drug might cause debilitating compulsive behavior.
If someone is prescribed Abilify by a doctor they trust, and there is no indication that the drug is even associated with these compulsive behaviors, it creates a nightmare scenario. The patient needs to get off Abilify in order to get better. But without the right information, the patient has no way of knowing the nature of the trouble they are in. They don’t know how to get help.
Now, people have come together, joining 33 cases across 18 states into a multi-district litigation (MDL) proceeding, which will be heard before a federal judge in Florida.
A Case of Dangerous Priorities
Abilify hit the American market in 2002, and it quickly became a cash-cow for Tokyo- and New Jersey-based Otsuka, who marketed the drug aggressively. In 2013 the drug brought in sales of $2.3 Billion. As the drug became more common, though dangerous patterns began to emerge.
As early as 2012, the European Medicines Agency (EMA) noted reports of “pathological gambling” associated with the drug. They recommended making patients with a prior history of gambling aware that they were at an increased risk of these compulsive behaviors.
In a 2015 Safety Review, Health Canada found, “evidence of a link between the use of Abilify and Abilify Maintena and an increased risk of certain impulse control behaviours: pathological gambling and uncontrollable sexual behaviours (hypersexuality).”
After the FDA’s 2015 Safety Communication, one might think that Otsuka would recognize and address the problem. But according to the lawsuit, Otsuka has not:
“[…] notified or warned patients, the medical community, or prescribers in the United States that Abilify use causes, is linked to, and is associated with compulsive gambling, pathological gambling, or gambling addiction.”
A patient might ask their doctor, but it is not as if Otsuka sent letters to inform physicians prescribing the drug of the dangerous side-effects. Nor, as the suit alleges, has Otsuka conducted or make public any studies or investigations they might have done.
Between August 2013 and December 2014, Abilify accounted for $10.6 Million in payments made to over 21,000 doctors in the United States. So Otsuka is happy to spend money pushing their drugs on doctors and on consumers in their in massive ad-campaigns. But what about looking into a side-effect that ruins patient’s lives? It doesn’t seem like a priority.
Study Calls for More Research
In 2016, a French study reported that on a 28-year-old male diagnosed with schizoid personality disorder. After switching to Abilify from another medication, the study documents how the man lost control. He developed an addiction to gambling, which spiraled into unpayable debts. They also note that:
“Before being treated with aripiprazole, he was an exclusive heterosexual with a poor sexual activity. Under treatment, he switched to a homosexual behavior with hypersexuality, unprotected sex and sadomasochistic practices. The craving for gambling and compulsive sexual behavior ceased two weeks after aripiprazole was discontinued and he was switched to amisulpride. Thereafter, he reported a return to a heterosexual orientation.”
Abilify is a powerful drug, and it can affect people in a number of life-altering ways. To conclude the study, the researchers offer an important perspective that Otsuka needs to take into account when, where, and how they market their drugs. The truth about Abilify is that the “side effects are little known. They are usually difficult for patients to mention due to feelings of guilt. The consequences on social life, family and health may be serious.”
Patients understand this. Families understand this. Now it’s time for Big Pharma to get on board.
Don’t Abandon Safety for the Sake of Profits
As more information comes out about the relationship between Abilify and compulsive behaviors, some things are clear. One, people who take drugs should have the knowledge they need to make safe and healthy decisions Two, people with a history of gambling are at a higher risk of having their life turned upside-down, and they have a right to know.
Especially with a drug like Abilify, where there is still so much unknown, companies should stay on the side of caution instead of focusing on larger revenues.