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Abilify, originally developed by Otsuka Pharmaceuticals Company and marketed in the U.S. by Bristol-Meyer Squibb (BMS), first gained approval by the U.S. Food and Drug Administration in November 2002 and was approved by the European Medicines Agency (EMA) in 2004.
Abilify is an atypical “second-generation” anti-psychotic medication used primarily for the treatment of schizophrenia and bipolar disorder. In some cases, Abilify is used in conjunction with other treatments and medications for patients suffering major depression, tic disorders such as Tourette’s Syndrome, and autism-related irritability.
Abilify (aripiprazole) is one of a number of “second generation” atypical antipsychotic medications, commonly known as SGAs. Other frequently-prescribed drugs in this class include Saphris (asenapine maleate), Clozaril (clozapine), Seroquel (quetiapine fumarate) and Risperdal (risperidone).
Like earlier “typical” antipsychotics such as Haldol (haloperidol), SGAs block receptors in the brain’s dopamine pathways, which are involved in reward-motivated behaviors. One of the advantages touted for SGAs over typical antipsychotics is that they are less likely to cause movement disorders, such as tremors associated with Parkinson’s disease. Unfortunately, relatively few SGAs have proven to be any better than earlier medications in this regard.
In fact, while SGAs have long been considered “safer” than first generation antipsychotic drugs, they have been shown to have their own dangerous side effects, which include:
FDA approval of Abilify was based on data gathered from five “adequate and well-controlled” clinical studies, four of which ran for six weeks or less and one lasting six months. The data from the short-term studies demonstrated a clear reduction in symptoms associated with psychoses, while the longer study showed a reduced rate of relapse in subjects who were given the medication compared with the placebo group.
Following initial approval in the U.S. for the treatment of schizophrenia, Abilify went on to receive the greenlight from regulators for:
By 2013, Abilify was the top-selling prescription drug in the U.S., with multi-billion dollars in sales. A generic version of Abilify has been available since April, 2015.
In 2005, a post-market study found that elderly patients treated with Abilify for dementia were at greater risk for premature death. Despite the fact that the FDA had never granted approval for this indication – and in fact, requested that a black box warning about the risk be included with packaging – BMS went ahead and aggressively marketed the drug to geriatric patients as well as children and adolescents for unapproved “off-label” purposes. When federal regulators discovered the company’s marketing tactics, BMS signed a “Corporate Integrity Agreement” with the government and paid $515 million to settle the allegations.
In July 2011, a paper published in the British Journal of Psychiatry reported three case studies in which patients found themselves obsessed with gambling and unable to control their impulses after having been prescribed Abilify.
One patient, who had already been under treatment for compulsive gambling, found himself turning to crime in order to fund his activities. Another patient, who had been spending half of his income on gambling activities prior to taking Abilify, was spending virtually all of his funds, admitting that gambling had become his reason for living. Another patient, who had never before played games of chance, found himself “experiencing strong urges to gamble in the form of a euphoric feeling when thinking about gambling,” eventually incurring debts of approximately £25 000 (approximately $40,000 USD) at Internet-based casinos. After discontinuing Abilify, the patient lost all desire to gamble.
In 2013, a study published in the journal Addictive Behaviors noted that overstimulation of dopamine receptors in the brain intensify feelings of pleasure. This is Abilify’s mechanism of action. Over the years following the drug’s approval, the FDA received more than 180 reports of uncontrollable behaviors linked to Abilify, which include:
Oddly, Abilify packaging in the European Union included warnings about this issue beginning in 2012, with Canada following suit in 2015. However, this warning did not appear on U.S. packaging until May 2016, when the FDA ordered that such information be included on Abilify labeling – and according to FDA officials, even this warning was inadequate. It is not clear as to why such warnings were not given in the U.S. until such time as the manufacturers were forced to do so.
In December 2016, BMS paid $19.5 million to the U.S. Justice Department to settle allegations of minimizing the risks of Abilify, misrepresenting data from clinical studies, and illegally promoting the drug for off-label purposes. Despite this and the growing number of Abilify lawsuits, Otsuka filed a New Drug Application with the FDA in May 2016 for a new form of Abilify containing an ingestible, digital sensor. That application is currently under review.
More than 2,000 lawsuits have been filed against the manufacturers of Abilify. Plaintiffs claim Abilify was responsible for their compulsive, uncontrollable behavior, resulting in financial and personal damages. They further allege that the manufacturers were aware of these potential side effects yet failed in their duty to warn consumers and medical professionals.
For extensive information on these court proceedings, visit our Abilify Lawsuit Page. This page describes in detail the litigation pending against Otsuka Pharmaceutical and Bristol-Myers Squibb, and how someone injured by Abilify can participate in the court proceedings and receive compensation for their injuries.
Levin Law