States Allege BMS Marketed Abilify Improper Marketing Antipsychotic to Children, Elderly. In a multistate settlement, Bristol-Myers Squibb agreed to pay $19.5 million to settle allegations of improper marketing with its atypical antipsychotic drug, Abilify. The drug maker allegedly marketed Abilify to children and the elderly, even though the U.S. Food and Drug Administration (FDA) had not approved these indications. An investigation conducted by 43 state attorneys general found that BMS improperly marketed Abilify to children and the elderly and made misrepresentations about the drug’s benefits while failing to warn of the risks.
“We allege that Bristol-Myers Squibb improperly marketed this drug to encourage prescriptions to children and seniors and misled the public about its safety for those populations,” said Massachusetts Attorney General Maura Healey in a Dec. 8 press release. “Companies cannot use deceptive practices and unfair marketing to increase their sales at the expense of patients’ health and well-being.”
The attorneys general alleged that BMS marketed Abilify off-label, or for uses not approved by the FDA. Pharmaceutical companies are not allowed to promote their products for unapproved uses, although physicians can prescribe off-label if they believe it will benefit the patient. Abilify was approved in 2002 to treat patients with schizophrenia. Since then, the drug’s indications have been expanded to include other patient populations.
The Abilify multistate settlement resolves allegations that BMS marketed Abilify to treat elderly patients with symptoms of dementia “despite the lack of FDA approval for these uses, and without first establishing the drug’s safety and efficacy for those uses” according to the release. In 2006, a boxed warning, also known as a “black box warning” was added to the Abilify label. The boxed warning, which is the FDA’s strongest type of warning, cautioned that antipsychotic medications in elderly patients with dementia-related psychosis are associated with an increased risk of death.
The states also alleged that BMS improperly marketed Abilify for pediatric patients. The company allegedly overstated the findings of certain studies while failing to warn about the dangers.
Abilify Gambling Addiction, Compulsive Behavior Lawsuits
Abilify pathological gambling and compulsive behavior lawsuits have been filed against BMS, Parker Waichman notes. Plaintiffs allege that the antipsychotic medication triggered impulse-control problems, mostly gambling, after taking Abilify. Lawsuits often allege that the habit led to financial ruin. BMS is accused of knowing about this risk, but failing to warn patients or the medical community. Lawsuits point out that, in Europe, the Abilify label has warned of pathological gambling for several years.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) created a federal multidistrict litigation (MDL) for Abilify lawsuits alleging gambling and compulsive behaviors. MDLs transfer similar lawsuits to one court. The goal is to make complex litigation more efficient by streamlining the legal process. Plaintiffs in the Abilify MDL similarly allege that BMS failed to disclose the risk of pathological gambling and impulse-control problems with Abilify.
U.S. District Judge M. Casey Rodgers is presiding over the Abilify MDL in the Northern District of Florida. According an Oct. 3 Transfer Order, 40 Abilify lawsuits were transferred into the MDL.
Plaintiffs in the MDL allege that taking Abilify caused them to develop a gambling addiction. Abilify users have also reported compulsive behaviors, including binge eating, hypersexuality and excessive shopping or spending. These behaviors were typically new in patients and stopped once the drug was lowered or discontinued. Lawsuits allege BMS knew Abilify presented these risks, but failed to disclose this information to patients and their physicians.
A number of plaintiffs in the Abilify litigation lost large sums of money due to their gambling addiction, allegedly caused by Abilify. According to Reuters, one Tennessee man lost $375,000 in six months while taking the antipsychotic.
Another plaintiff who took Abilify from May 2013 to August 2014 lost $75,000 in gambling. Generally, the pathological gambling reported with Abilify was among users who did not have a history of gambling addiction. Some plaintiffs allege the habit became so severe that they stole money to continue gambling.
Lawsuits cite warnings in Europe disclosing a risk of gambling addiction. The European Medicines Agency pushed for a label update in 2012 cautioning that “reports of pathological gambling have been reported among patients prescribed Abilify, regardless of whether these patients had a prior history of gambling.” The Abilify label in Canada was updated last year with a similar warning.
“Despite these warnings and advisories in Europe and Canada-for the same drug sold to patients in the United States-the labeling for Abilify did not adequately warn about the risk of compulsive gambling and contained no mention that pathological gambling has been reported in patients prescribed Abilify,” language in the complaints state, according to The Daily Beast.
Researchers have studied impulse control problems with drugs like Abilify. Thomas J. Moore, senior scientist at the consumer safety watchdog group Institute for Safe Medication Practices (ISMP), published a study in 2014 showing that “the associations were significant, the magnitude of the effects was large, and the effects were seen for all 6 dopamine receptor agonist drugs.”
Moore explained the results to The Daily Beast, stating “The drug triggers a pathological urge to gamble constantly, sometimes among persons with no previous interest,” he said, regarding Abilify and its effect on dopamine receptors. “It might be people starting to spend $300 a week on lottery tickets, and in other cases people will gamble away tens of thousands of dollars.”
“We live in a society whose rules and laws assume people are responsible for their actions, including running up a large gambling debt,” he said. “But we have scientific evidence that sometimes a drug can trigger a pathological urge to gamble so severe it can ruin someone’s life.”
Abilify Warning Label Updated to Include Impulse-Control Problems
In May 2012, the FDA said the Abilify warning label would be updated to encompass more compulsive behaviors reported among users, including uncontrollable urges to gamble, binge eat, shop and have sex. The updated label affects Abilify, Abilify Maintena, Aristada and generic aripiprazole. These compulsive behaviors stopped once the medication was lowered or discontinued, the agency said.
The FDA noted that Abilify already carries a warning for pathological gambling, but this does not address other impulse-control problems, including binge eating, shopping and sexual behaviors. Gambling addiction is the most common behavior reported.
“In the majority of cases, patients with no prior history of the compulsive behaviors experienced uncontrollable urges only after starting aripiprazole treatment. Within days to weeks of reducing the dose or discontinuing aripiprazole, these uncontrollable urges stopped.” FDA said.