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Abilify makers approach deadline for “global settlement”

One woman says Abilify turned her into a compulsive gambler, losing a total of $75,000 she secretly took from a loan and her family’s bank account during a six month period while taking the pill. She lost the interest in making bets immediately after she was taken off the drug.

Another woman says Abilify got her hooked on sex and spending. She began sexting pictures of herself and set up a sexy Facebook page to connect with strange men. She would also spend excessively, buying cars she didn’t need and taking out a loan to build an addition on the garage. The woman and her husband, who found out about the Facebook and sexting, later had to file for bankruptcy. Months later, they saw a commercial for the medication that warned of such behavioral side effects and made the connection.

Bristol-Myers Squibb and Otsuka America, the two pharmaceutical giants that make and distribute Abilify in the U.S., have until Sept. 1 to establish a “global settlement” for more than 800 lawsuits brought on by victims like these who claim the antidepressant/antipsychotic caused their impulse control to go out the window. They say the drug triggered sudden urges to binge eat, shop, gamble and have sex. This was the deadline given by Judge M. Casey Rodgers in the Northern District of Florida, which is handling all the lawsuits consolidated into a multidistrict litigation case.

The judge first selected three cases from the MDL earlier this year for the drug companies to settle as “bellwether test cases” to set a precedent. They did settle each case individually for undisclosed sums. If Bristol-Myers and Otsuka cannot reach a settlement with the other 800 or so victims – and that could grow -- the court will take a sample of them to trial.

The U.S. Food and Drug Administration first approved Abilify (generic name aripiprazole) in 2002 to treat schizophrenia. A short time later, it was approved for treating bipolar disorder, Tourette’s syndrome, depression and irritability in children with autism. But doctors were also prescribing it off-label for other conditions, including anxiety and eating disorders.

It is still unclear today how Abilify causes compulsive behavior and lack of impulse control, but it is known to activate dopamine receptors, which play a role in reward-seeking and addictive behavior.

Since its approval in 2002, sales of Abilify in the U.S. have topped more than $51 billion. In 2012, the European Medicines Agency – their equivalent of the U.S. FDA – ordered the makers of Abilify to carry a special warning on the label noting the reports of compulsive gambling. Three years later, regulators in Canada – where some have estimated another 800 lawsuits may be pending -- ordered that prescriptions warn consumers about a risk of gambling and hypersexuality.

The FDA didn’t get with the program until 2016 when it added a warning that “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and their generics).

“These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced,” the FDA warning said. “These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.”

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