Abilify (aripiprazole) is an antipsychotic medication designed to provide relief from severe and debilitating symptoms of certain mental illnesses. It is part of the second generation of atypical antipsychotic medications, also referred to as SGAs. Abilify works by inhibiting or enhancing dopamine levels in the brain to keep a balance. That effect makes it a useful tool to reduce hyperactivity, moodiness, and aggressive behaviors.
Abilify was developed by Otsuka Pharmaceuticals Co., which partnered with Bristol Myers Squibb in 1999 to complete development, obtain FDA approval, and market the drug in the U.S. Abilify was first approved by the U.S. Food and Drug Administration (FDA) in November 2002. Otsuka Pharmaceuticals makes the medication in tablets and also makes Abilify Maintena, which is an extended-release injection.
Abilify is approved by the U.S. Food and Drug Administration (FDA) to treat schizophrenia, a mental illness characterized by hallucinations, delusions, and similar symptoms that affect a person’s normal life. The drug was also approved to treat manic episodes for individuals with bipolar disorder and can be used in combination with another drug as a long-term maintenance drug for bipolar disorder. It can also be used as an adjunct for treating a major depressive disorder, Tourette’s disorder, and irritability seen in people with autistic disorder.
Many physicians have prescribed Abilify for off-label uses, including anxiety, insomnia, and delusional disorders. The drug has also been prescribed to children with autism and elderly patients with dementia-induced psychosis,while it’s not illegal for a doctor to give an off-label prescription, it’s illegal for the drug makers to market the off-label uses of a drug. The off-label uses of Abilify have not been studied for safety and efficacy, and the FDA has not approved the drug for these uses. Since Abilify manufacturers sought to expand the drug’s sale by marketing its off-label uses, Bristol-Myers Squibb was hit with a $515 million fine by the Justice Department.
The sales began to soar after the drug could be prescribed for depression. With over 16 million Americans suffering from depression, Abilify sales exploded once it was approved to treat depression. Abilify was the top-selling drug between 2013 and 2014 and sold more than other major anti-depressants combined. This growth in sales was due in large part to direct-to-consumer advertising.
How Abilify Works
Experts aren’t completely sure how Abilify works, but it’s becoming clear that the drug works by mimicking the effects of dopamine in the brain. Scientific studies have long identified dopamine as a source of reward-seeking behaviors. Dopamine is a neurotransmitter that helps regulate the reward and pleasure centers of the brain. As Psychology Today explains, dopamine regulates a person’s emotional response, allowing them to see rewards and also move toward them. There’s only a general understanding of how Abilify affects brain chemistry and helps relieve symptoms of brain disorder. It’s therefore also unknown- to the manufacturer and the FDA- how Abilify might cause compulsive behavior. However, researchers believe that the drug’s ability to modify dopamine pathways may explain uncontrollable compulsions experienced by some patients. This link did drive the Health Canada and European Medicines Agency to order Abilify manufacturers to change labels on Abilify to reflect the risk for gambling addiction and other compulsive behaviors.
Excessive levels of dopamine can lead to dysfunction and psychosis while deficient levels can result in depression. Abilify strikes the right balance of dopamine in order to regulate mood. The heavily aired Abilify commercial stated that the drug works “like a thermostat to restore balance in the brain.” Another advert stated that Abilify lowers or raises the activity of key brain chemicals when it’s too high or too low, respectively. Critics consider these advertising claims as being debatable since there’s a poor understanding of the workings of the brain and the causes of mood disorders. Additionally, the phrasing used in the drug’s insert indicates that Abilify’s mechanism of action is unknown.
Side Effects of Abilify
Some of the most common side effects of Abilify or its generic counterparts include constipation, anxiety, nausea, vomiting, headaches, fatigue, restlessness, blurred vision, insomnia, drowsiness, tremor, and dizziness. Less common, but severe side effects include a dry mouth, muscle aches, increased appetite, seizures, and agitation. Due to a possible increased appetite, Abilify can result in weight gain and associated problems such as high blood sugar levels, high cholesterol, and high blood pressure. The restlessness and agitation experienced by some people can be associated with extrapyramidal effects or tardive dyskinesia, both of which cause muscle symptoms such as jerky movements, stiffness, and tremors.
Abilify has also been linked to increased levels of prolactin in the blood. This hormone can affect men and women in different ways. Women may stop having their periods, while men may experience erectile dysfunction or a lower sex drive. Prolonged elevated levels of prolactin can cause osteoporosis and weakened bones in both men and women. As with other antipsychotic drugs, Abilify has a lower risk of causing the neuroleptic malignant syndrome, a rare and dangerous condition that requires emergency medical treatment. Symptoms of this condition include confusion, muscle stiffness, sweating, and fever. Another rare condition that may be associated with antipsychotics is an arrhythmia, which causes sudden cardiac death.
Abilify Black Box Warnings
Abilify is required by the FDA to carry a black box warning on its packaging. This is a type of warning that informs healthcare providers and patients of serious and life-threatening side effects of the drug. The black box warning for Abilify indicates that the drug can increase the risk for suicidal thoughts and behavior in adolescents, children, and young adults using the drug to treat depression. Patients are advised to monitor for the worsening or emergence of suicidal thoughts and behavior. The black box warning also warns that this medication increases the risk of stroke that can lead to death for elderly people who have dementia. As such, Abilify is not recommended for elderly patients with psychosis related to dementia or patients under the age of 24.
Impulse Control Issus Caused by Abilify
A 2014 study published in JAMA Internal Medicine found a link between dopamine receptor agonist drugs and serious control disorders. The study showed that there was a significant association and that the magnitude of the effect was large. The study analyzed adverse drug event reports submitted to the FDA from 2003 and 2012. A total of 710 events indicated impulse control disorders with drugs such as Abilify. The most frequent behavior reported was gambling, followed by hypersexuality, pyromania, and compulsive shopping. When Abilify was approved by the FDA, it did not have a black box warning indicating the risk of compulsive behaviors on its label. Oddly, the drug manufacturers included this warning on packages sold in the European Union and Canada several years ago.
In 2016, however, the agency added new warnings about the impulse control issues to the drug labels and patient medication guides. The FDA published a safety announcement warning addressing the public about reports of uncontrollable urges to binge eat, gamble, have sex, and shop when taking Abilify. The agency reviewed reports submitted from the time the drug was approved in 2012. The addition of this warning label was in response to about 200 reported cases of compulsive behaviors by patients using Abilify. The FDA warned that impulse control problems related to the use of Abilify could cause harm to the patient and others if not recognized.
- Compulsive Gambling
Although this side effect was not outlined on initial official inserts, studies have found that some people may develop compulsive gambling. Most of the research has delved into descriptions of patient experiences while using Abilify. These case studies show that when Abilify was used to treat schizophrenia, the drug triggered a pathological urge to gamble even in patients with no previous problem gambling behaviors. In three case studies, gambling was considered pathological, meaning that it was constant, and the patients just could not stop. Pathological gambling may mean people developing gambling problems, and starting to spend $500 a week on lottery tickets or others will spend tens of thousands of dollars. However, the urge to gamble ceased as soon as they stop using Abilify or as the dose was reduced.
Compulsive behaviors are driven by a brain chemical referred to as dopamine. This substance is released when a person does something that brings some sort of pleasure, such as a win at the slots machine. People with addition typically get hooked on this feeling. Dopamine is released when Abilify is taken, which may explain why some people behave compulsively. Compulsive gambling is a serious condition that can cause severe financial, personal, and social harm. Problem gamblers are often unable to control the gambling urge. As such, they can end up gambling with money meant to handle other important things, amass credit card debt, lose their jobs and personal relationships, end up with poor mental and physical health, and even land in jail as their addiction deepens.
Abilify manufacturers had not warned doctors and patients that there was a possibility of developing compulsive behaviors. Many people have reported losing significant amounts of money due to pathological gambling, and yet the manufacturers had not been required to list it as a side effect. People who developed gambling problems when taking the drug may have a very strong case for getting compensation for their losses.
Hypersexual activity is another side effect of Abilify. Patients may experience hypersexual behavior when they start using aripiprazole, according to the FDA. The sexual side effects, however, are not as common as compulsive gambling. From the reports submitted to the FDA, hypersexuality resolved after the patients stopped taking Abilify.
- Other Potential Risks
Abilify may increase the risk of seizures; thus, it may not be recommended to patients with a risk of epilepsy of seizures. The medication can also lead to pneumonia if patients with difficulty to swallow or inhale food. Abilify may also increase the risk of developing diabetes as it increases blood sugar levels.
Is Abilify Safe as an Antidepressant?
The sales of Abilify began to surge after Abilify was approved for depression. In a benefit-risk evaluation report by Otsuka, the company admitted that the efficacy and safety of the drug as an add-on to antidepressants had not been evaluated in long-term controlled trials. Another study showed that there is limited evidence that Abilify reduces the symptoms of depression when added to antidepressants and that side effects are more frequent in augmentation treatment using Abilify. In addition, a review of randomized clinical trials showing how Abilify stacks up against other schizophrenia drugs concluded that the information was incomplete, of limited quality, and difficult to apply clinically. However, despite the lack of scientific support, Otsuka continued to market Abilify as superior to competitors.
The FDA took the Otsuka Pharmaceuticals and Bristol-Myers Squibb to task in a 2015 letter which stated that the claims were misleading because they implied that Abilify was a better drug than those already approved for the treatment of bipolar disorder when it has not been demonstrated. The manufacturer’s downplaying of the drug’s potential risks resulted in a $19.5 million fine.
Hundreds of people have filed lawsuits claiming that Abilify made them compulsive. They claim that the drug prompted behaviors such as excessive gambling, spending, sex, and eating. Other compulsive-behavior side effects included in the lawsuits include suicidal thoughts and attempts, as well as compulsively playing video games and viewing pornography. Since January 2016, Abilify users who experienced sudden compulsive problems begun filing lawsuits against manufacture Otsuka Pharmaceuticals Co. and Bristol-Myers Squibb saying they weren’t adequately warned. One of the first cases was filed by a patient in Indiana, who claims that the harmful effect that the drug has on the brain could pass for physical injury. The plaintiff also claimed that Abilify manufacturers knew of the risks, but did not warn doctors and patients of the possible dangers.
As of April 2019, more than 2,000 people had filed lawsuits in federal court against the drug companies. Bristol-Myers Squibb and Otsuka Pharmaceuticals are accused of negligently designing the drug and concealing evidence that Abilify increases the risk of addictive behavior. Also, court records indicate the pharmaceutical companies failed to properly to test Abilify, exaggerated the drug’s benefits, and encouraged off-label use of the medication. The FDA has not approved Abilify to treat dementia, insomnia, eating disorders, anxiety disorders, post-traumatic stress disorder, or obsessive-compulsive disorder. Still, the manufacturers of Abilify persuaded physicians to prescribe it for these conditions.
Abilify Lawsuits are Handled in an MDL
Lawsuits involving dangerous drugs can take multiple forms. In addition to the individual lawsuits filed against Bristol-Myers Squibb and Otsuka Pharmaceuticals for Abilify side effects, hundreds of cases have been centralized in multidistrict litigation (MDL). This is a type of legal procedure that involves the consolidation of lawsuits from various states that share similar facts. In MDL, the same evidence will work for each case, allowing the courts to streamline discovery and pre-trial proceeding. In addition, settlement in a mass tort MDL is based on each victim’s individual case. So unlike class action lawsuits, which involve offering the same amount of compensation to each victim that qualifies, an MDL allows each Abilify victim to seek compensation based on their specific damages.
An MDL against Abilify was formed in October 2016 and is being handled by the United States District Court for the Northern District of Florida. The current and future cases are consolidated into MDL #2374. This MDL is not the only ongoing proceeding
With Otsuka Pharmaceuticals and Bristol-Myers Squibb named as defendants, plaintiffs allege some combination of the following:
- The drug harmed patients because it caused uncontrollable urges, resulting in psychological, financial, and physical damages.
- Bristol-Myers Squibb and Otsuka knew or should have known that the drug causes and contributes to compulsive behaviors
- Abilify makers put people in unnecessary danger by failing to study the drug and its side effects sufficiently
- The manufacturers did not warn physicians and patients of the relationship between their product and compulsive behaviors
- The manufacturers spent millions of dollars on misleading advertising that understated the risks and overstated the benefits
- The benefits of Abilify do not outweigh the risks
- The manufacturers made huge payments to doctors to promote the drug
- Bristol-Myers Squibb and Otsuka convinced physicians to prescribe the drug for “off-label” conditions
- The manufacturers hid evidence from the government when the drug was approved by the FDA
- Abilify labeling contradicts European and Canadian labeling, which warns of compulsive behaviors
Lawyers argue that if physicians understood the real risks from using Abilify, the physicians would have prescribed a different antipsychotic to treat a patient, or would have used a different drug once the patient started experiencing compulsive behavior.
Plaintiffs can pursue financial recovery if they can show that they spent more than $10,000 due to the uncontrollable behaviors, or can prove that they gained weight as a result of binge eating. This can help pay for past and future medical treatment for the addiction and compensate them for pathological gambling, shopping losses, and lost income. Plaintiffs can also recover damages for the mental suffering caused by the effects of the addiction, such as harm to the victim’s reputation, social stigmatization, and loss of friends and loved ones. Additionally, the courts may also award punitive damages to keep Byers-Myers Squibb and Otsuka Pharmaceutical accountable for their deceptive marketing prices and deter drug manufacturers from their grossly negligent actions.
Abilify Lawsuit Settlement Amounts
The government accused Bristol-Myers Squibb of marketing Abilify for off-label uses and to unapproved age groups, including children and elder patients. The allegation also claimed that the pharmaceutical company had purposefully inflated the price of the drug. The government also claimed that the pharmaceutical company made illegal payments to doctors in 2000 and 2003 and provided similar illegal benefits to pharmacies. More than 21,500 doctors received millions in payments related to the promotion of Abilify, according to ProPublica. In 2007, the drug maker paid a $515 million penalty to the federal government to settle the claims. In 2008, Otsuka Pharmaceutical Co. also paid a $4million settlement to the U.S. government for claims that the corporation marketed Abilify to nursing homes and child psychiatrists for off-label uses.
In 2016, BMS and a coalition of 43 states and the District of Columbia reached a $19.5 million settlement for claims that the drug maker misinterpreted data from clinical trials, minimized the risks of Abilify, obscured data about the drug’s side effects, and illegally promoted the drug for off-label uses. In addition, BMS paid $30 million to the state of California for making illegal payments to doctors to prescribe Abilify.
At the end of April 2018, Otsuka Pharmaceuticals and Bristol-Myers Squibb settled three bellwether lawsuits for an undisclosed amount. This settlement led some legal experts to believe that all remaining Abilify lawsuits might be settled as well.
In a case management order issued on February 15, 2019, the court directed all plaintiffs who alleged that Abilify caused uncontrollable gambling urges to appear for a conference since Otsuka Pharmaceuticals Co., and Bristol-Myers Squibb had agreed on a global settlement to resolve most of the lawsuits pending in the federal court MDL. As of May 2019, the terms of the settlement remain undisclosed and are under review by plaintiffs’ attorneys. The order stated that the agreement resolves all cases pending in the MDL as of January 28, 2019, and those in the process of being transferred the multidistrict litigation. The settlement also covers cases in California state courts, multicounty litigation in New Jersey, and any other pending cases in a federal or state court.
Find an Abilify Lawsuit Attorney Near Me
Attorneys are filing Abilify lawsuits against Bristol-Myers Squibb and Otsuka Pharmaceuticals. If you took Abilify and began to have compulsive behaviors, which caused emotional distress, economic hardship, and other losses, you may have a case. The drug lawsuit experts at Consumer Alert Now can help you understand Abilify Mass Tort matters and connect you to a trusted law firm for assistance. If you suffered harm anywhere in the U.S., contact Consumer Alert Now at 800-511-0747 to learn your rights and options.