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Abilify, part of a class of drugs known as atypical antipsychotics, is a medication prescribed for schizophrenia, bipolar disorder, major depressive disorder, and certain autistic behaviors. Generically known as aripiprazole, the medication is given to nearly a million Americans per year.

But, as is the case with many antipsychotics, Abilify has been scrutinized in recent years for over-prescription, partially from illegal off-label usage. Further, certain side effects – most not included on the warning label – have made Abilify the subject of multiple lawsuits.

Risks for Elderly Patients

In 2008, the FDA required warning labels for Abilify and other antipsychotics to include a disclaimer about a risk of death and increased suicidal ideation when given to elderly patients.

At one point, nearly a quarter of nursing home residents were prescribed antipsychotics to manage behavioral issues, such as irritability and aggression. A federal lawsuit against Bristol Myers Squibb later revealed that the manufacturer targeted nursing homes for illegal off-label use from 2002 to 2005 and additionally went after children for similar behavioral issues. Homes accepting bribes from the manufacturer have also been involved in these lawsuits.

Analyzing its effects on the elderly, studies have shown that these medications:

  • Increase suicidal ideations and thoughts for elderly patients, particularly those suffering from dementia-related psychosis
  • Increase elderly patients’ risk of stroke and death
  • May have harmful side effects like anticholinergic reactions, parkinsonian events, tardive dyskinesia, orthostatic hypertension, cardiac conduction disturbances, reduced bone density, sedation, and slower cognitive abilities when given to elderly patients.

Diabetes

Multiple studies have further identified increased diabetes risks for patients taking Abilify and other antipsychotics.

Initially, a Vanderbilt University study shed light on this concern, particularly for children prescribed antipsychotics. Researchers monitoring a group of patients between 6 and 24 years of age over a 12-year period discovered that children given these drugs saw their diabetes risks triple almost immediately. Patients’ risks, however, didn’t drop until they had been off the antipsychotic for nearly a year.

Yet, in spite of these findings and another supporting study published in Psychopharmacology Bulletin, antipsychotic prescriptions for children grew seven times from 1998 to 2009.

Gambling and Other Compulsive Behaviors

As a more recent finding, Abilify specifically is associated with compulsive or pathological gambling. According to data from FDA reports, this antipsychotic was behind 54 cases of compulsive behavioral problems from 2013 to 2015: 30 reports of compulsive gambling, 12 for general impulsive behavior, nine for hyper-sexuality, and three for compulsive shopping.

How could this occur? Abilify affects the brain’s dopamine and serotonin receptors, over-stimulating the former. As dopamine receptors specifically regulate mood and behavior, the drug may directly cause a patient to engage in compulsive actions, including gambling, shopping, or sex addiction.

Although this side effect appears minor at a glance, studies and accounts indicate devastating ramifications – and alarming behavioral issues that come out of nowhere.

One 2011 case study by Cohen, et al., found that patients given Abilify for schizophrenia started developing gambling habits as a side effect. That same year, a British study conducted by the National Problem Gambling Clinic came across a similar issue: Patients taking Ability became consumed by gambling, engaging in it and thinking about it constantly.

Two years later, a French study by Gaboriau, et al., examined patients who checked into a clinic for compulsive gambling. Out of this group, seven out of eight taking Abilify couldn’t control their gambling habits but were able to stop the behavior once off the antipsychotic.

Along with these findings, FDA reports describe patients taking Abilify who lost anywhere from $40,000 to $75,000 by compulsive gambling. However, these individuals, prior to taking the medication, had no history of gambling addiction.

Compulsiveness doesn’t always manifest as gambling. Other related side effects have included:

  • Overeating leading to weight gain
  • Constant sexual thoughts and feelings
  • Uncontrollable shopping

In all cases, the behavior emerged after the patient started taking the drug. The patient, as well, isn’t able to recognize that his or her behavior is unusual.

In response, multiple plaintiffs have come forward to file claims against Bristol-Myers Squibb and Otsuka Pharmaceuticals Co., alleging the manufacturer didn’t warn them about this side effect. Additionally, they claim they suffered economic loss, neuro-psychiatric and physical injuries, and emotional distress as a result. While Abilify sold in Canada and Europe comes with a disclaimer about compulsive behaviors, drugs in the U.S. don’t include this warning label.

Other Side Effects

Data has associated Abilify and other antipsychotics with other life-changing or detrimental side effects:

  • Tremors and uncontrollable movements
  • Birth defects: Specifically, if an infant is exposed during the third trimester, the child may develop abnormal muscle movements and withdrawal symptoms. Addressing this issue, the FDA required a warning label about this risk be added in 2011.
  • No effect at all: According to 2011 articles in the New York Times and The Journal of the American Medical Association, veterans have been prescribed Abilify and other antipsychotics to treat PTSD. Yet, considering the serious side effects associated with the drug class, its influence is minimal. In fact, data found that groups given an antipsychotic and a placebo both had the same recovery rate.