When Abilify was first approved for the treatment of schizophrenia in 2002, it was touted as an effective new option to treat serious mental illness. What users of the antipsychotic medication did not realize was that Abilify had hidden side effects that could change their lives forever.
Users allege that taking Abilify caused them to develop compulsive behaviors, including binge eating, hypersexuality, and pathological gambling. After several studies and dozens of reports confirmed a link between the drug and compulsive behavior, regulators around the world took aim at the drug.
Now, hundreds of people have filed lawsuits against drugmakers Otsuka Pharmaceutical Co. and Bristol-Myers Squibb Company over claims that they knew about the side effects but did nothing to warn consumers.
History of Abilify
Abilify, also known by its generic name aripiprazole, is a medication used to treat psychotic conditions, such as schizophrenia and bipolar disorder.
It was first discovered by scientists working for Otsuka Pharmaceutical in the 1990s. The company later partnered with Bristol-Myers Squibb to finish the drug, get approvals for use, and market the drug.
Abilify was first approved for use in the treatment of schizophrenia in adults by the U.S. Food and Drug Administration (FDA) in November 2002. Two years later, the drug was approved for treatment of acute manic and mixed episodes associated with bipolar disorder.
In 2007, its use was further expanded to include treatment for major depressive disorder1
when used in conjunction with antidepressants. That same month, the FDA approved Abilify to treat schizophrenia in teens1
between 13 and 17 years old.
In November 2009, Abilify was approved to treat irritability in children with autism. This allowed the drug to be administered to patients between 6 and 17 for aggression toward others, self-injury, uncontrollable tantrums, and mercurial moods, according to Reuters2
Over the course of its more than 15 years on the market, Abilify has been prescribed to millions of people. The FDA reported that approximately 1.6 million people received a prescription for aripiprazole from a retail pharmacy in 2015.
The drug has brought in billions of dollars for Otsuka and Bristol-Myers Squibb. It was the best-selling drug3
in the United States in 2014, bringing in about $7 billion a year.
How Does Abilify Work?
Abilify is an atypical antipsychotic, also known as a second-generation antipsychotic (SGA). Whereas the older generation of antipsychotics targeted dopamine receptors in the brain, the newer generation works on both dopamine and serotonin receptors.
Dopamine is a chemical released by nerve cells in the brain. It is a chemical signal sent between neurons. While it sounds simple enough, the effects of dopamine on the brain are varied. One of the most well-known effects of dopamine is the role it plays in reward-motivated behavior.
Serotonin, on the other hand, plays a role in every part of the body. According to Healthline4
, the chemical is seen as a natural mood stabilizer that helps reduce depression, regulate anxiety, heal injuries, and more.
Abilify works by enhancing or inhibiting dopamine and serotonin to balance mood and behavior, rather than completely blocking the receptors like other SGAs. As a result of the rebalanced dopamine and serotonin levels, a patient should see improved thinking, mood, and behavior.
Common Abilify Side Effects
Like all drugs, Abilify has side effects. The prescribing sheet5
says some of the most common side effects include (but are not limited to):
Upper respiratory illness
Serious Abilify Side Effects
Less common but more serious side effects have also occurred in those taking Abilify. These can include:
Low blood pressure
Involuntary, repetitive movements
Low blood count
High blood sugar
Stroke in the elderly
Neuroleptic malignant syndrome
Unregulated body temperature
Studies Link Abilify to Pathological Gambling
Although the prescribing sheet for Abilify now warns users of possible unusual urges like compulsive shopping and gambling, users were previously unaware of the link. However, experts have known about the risks since the mid-2000s.
One of the first studies to report a link between Abilify and compulsive gambling was published in 2011 in British Journal of Psychiatry6
. Researchers followed three patients who reported an increased desire to gamble pathologically after taking the drug. The patients all reported similar changes.
In one case, the patient described an escalation in his gambling habits that led to spending all of his money after three months of taking aripiprazole. He spent eight hours a day looking for free gambling opportunities after his money was spent. Within three months of ending treatment with aripiprazole, he felt no compulsion to gamble.
in 2011 reported similar findings. Three patients who had no previous history of pathological gambling prior soon became addicted to gambling following treatment with aripiprazole. The behavior then quickly ended after treatment with aripiprazole stopped.
Pathological gambling was one of the first compulsive behaviors associated with Abilify. However, studies also reported other potentially devastating behaviors.
One 2014 study in the Journal of the American Medical Association8
noted impulse control disorders among those taking dopamine receptor agonist drugs like Abilify. The disorders included pathological gambling, hypersexuality, and compulsive shopping.
Regulators Targeted Abilify Over Side Effects
As studies and reports about unexpected compulsive behaviors began coming in, regulators around the world started taking action.
In 2012, the European Medicines Agency — the European equivalent of the FDA — required Abilify’s labels to include a warning9
of pathological gambling after several post-market reports from patients prescribed the drug.
Health Canada issued a safety review to evaluate the link between Abilify and compulsive behaviors. In November 2015, the Canadian regulatory agency concluded10
that “there is a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality.” It subsequently updated Abilify’s labels to reflect the conclusion.
The FDA didn’t issue its safety announcement until mid-2016 when it warned11
that “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole.” By then, the agency had received dozens of reports of the behavior.
A warning of compulsive behaviors was added to the label in August 20165
Hundreds File Lawsuits Against Abilify Makers
Although the FDA updated Abilify’s labels to include warnings for compulsive behavior in 2016, the damage had already been done to countless users of the drug. As a result, patients began filing lawsuits against Otsuka and Bristol-Myers Squibb.
Plaintiffs claim that the two companies knew or should have known that Abilify carried an increased risk of compulsive behaviors. Otsuka and Bristol-Myers Squibb are accused of designing and manufacturing a defective drug and failing to warn the public of life-altering side effects.
With regulators in other countries adding warnings as early as 2012, plaintiffs say the companies could have warned doctors and patients of the side effects before 2016.
In one complaint12
, plaintiffs Joseph and Merideth Edgar filed a lawsuit against Otsuka and Bristol-Myers Squibb for a failure to warn of risks and designing a defective drug. Joseph was prescribed Abilify in 2009 and quickly began compulsively gambling after taking the drug. As a result, he lost more than $36,000 and suffered other mental, physical, and economic losses.
His case is not unlike the hundreds of others pending against the companies.
Status of Pending Abilify Lawsuits
Litigation related to Abilify remains ongoing.
In 2016, hundreds of cases pending across the country were consolidated into multidistrict litigation (MDL) in the U.S. District Court in the Northern District of Florida. By transferring all like cases together in a single MDL, plaintiffs and defendants are better equipped to argue and defend their cases more efficiently.
According to the U.S. Judicial Panel on Multidistrict Litigation, there were more than 700 cases13
pending in the MDL as of March 2018.
The first cases related to Abilify and compulsive behavior are expected to head to trial as early as June 2018. These will act as bellwether trials to help gauge the strength of the cases against the drugmakers. Bellwether trials also determine whether a settlement will be reached and for how much.
Abilify Lawsuit Deadline Information
Due to the statute of limitations, there are specific deadlines for filing an Abilify lawsuit. The deadlines will depend on the individual state. There may also be deadlines on filing a lawsuit to be eligible for a future settlement.
Those who are interested in learning more about the deadline or finding out whether they have a case against the makers of Abilify are encouraged to contact a qualified attorney.