43 States Allege BMS Marketed Abilify Improperly to Children, Elderly
Bristol-Myers Squibb has agreed to pay $19.5 million to settle multistate allegations of improper marketing with its atypical antipsychotic drug, Abilify. According to a Dec. 8 press release issued by Massachusetts Attorney General Maura Healey, the Abilify settlement resolves allegations of improper marketing to children and the elderly. A total of 43 state attorneys general investigated BMS’ marketing of Abilify, and found that the drug makers made misrepresentations about the drug’s benefits while failing to disclose the risks.
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“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 AG Healey, according to the release. “Companies cannot use deceptive practices and unfair marketing to increase their sales at the expense of patients’ health and well-being.”
The U.S. Food and Drug Administration (FDA) approved Abilify in 2002 to treat schizophrenia. The drug has also been approved for other uses since then. The state attorneys general alleges that BMS started marketing Abilify for uses not approved by the FDA; this is known as “off-label” marketing. It is illegal for companies to market their products for unapproved uses, although physicians can prescribe off-label at their own discretion.
The states allege that BMS marketed Abilify to treat symptoms of dementia in elderly patients, “despite the lack of FDA approval for these uses, and without first establishing the drug’s safety and efficacy for those uses” the release states. A “black box” warning, the strongest type of warning, was added to the Abilify label in 2006 warning that antipsychotic medications are associated with an increased risk of death in elderly patients with dementia-related psychosis. Similarly, BMS allegedly marketed Abilify off-label for uses in children. The company was accused of overstating the findings of certain studies while failing to fully disclose the risks.
Lawsuits Allege Abilify Led to Pathological Gambling, Compulsive Behaviors
Parker Waichman comments that BMS is also facing Abilify lawsuits from users, alleging that the antipsychotic drug caused a gambling addiction, sex addiction and other compulsive behaviors. The FDA updated the warning label on Abilify to address these risks in May. Plaintiffs allege that BMS failed to disclose the risk of impulse-control problems. Federal lawsuits were recently centralized to a multidistrict litigation (MDL), a type of mass tort that transfers similar lawsuits to one court in order to make proceedings more efficient.
The Abilify MDL transferred over 40 lawsuits, according to the Oct. 3 Transfer Order. U.S. District Judge M. Casey Rodgers will preside over the litigation in the Northern District of Florida.
Lawsuits allege that Abilify caused plaintiffs to engage in compulsive behaviors, including gambling. Abilify users have also reported other impulse-control problems, including binge eating, hypersexuality and excessive shopping or spending. Allegedly, BMS was aware of the risks but failed to warn patients or the medical community.
Oftentimes, lawsuits are filed on behalf of individuals who allege that they suffered financial ruin due to their gambling. Reuters reports that one Tennessee man lost $375,000 in six months while taking Abilify.
One lawsuit was filed on behalf of a man who lost $75,000. He took Abilify from May 2013 to August 2014. Plaintiffs allege that the habit began after starting Abilify, and stopped once the drug was discontinued. Some plaintiffs say they stole money to support their habit.
Plaintiffs also cite earlier warnings in Europe that disclose a risk of compulsive gambling. “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.
In 2012, the European Medicines Agency pushed for a label update warning that “reports of pathological gambling have been reported among patients prescribed Abilify, regardless of whether these patients had a prior history of gambling.” A similar label update was implemented in Canada last year.
In May, the FDA announced that the Abilify warning label would be updated to include the risk of impulsive behaviors, including uncontrollable urges to gamble, binge eat, shop and have sex. The label on Abilify, Abilify Maintena, Aristada and generic aripiprazole were affected. The agency said once the medication was lowered or discontinued, these impulse control problems stopped.
Regulators noted that pathological gambling was already listed on the label, but this description did not encompass other compulsive behaviors reported by patients. Although pathological gambling was the most common complaint, users also reported binge eating, shipping and sexual behaviors.
“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.
Study Links Abilify to Compulsive Behavior
Studies have been conducted compulsive behaviors in Abilify patients. Thomas J. Moore, senior scientist at the consumer safety watchdog group Institute for Safe Medication Practices (ISMP) has conducted extensive research analyzing potential side effects associated with drugs like Abilify. He 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 told The Daily Beast, “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.”
Filing an Abilify Lawsuit
If you or someone you know suffered a gambling addiction or other compulsive behavioral issues after taking Abilify, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).