Abilify, the 2013 top-selling drug on the U.S. market changed actions in the brain in an “unknown” way. For this reason, it should be no surprise that this drug could lead to a number of Abilify lawsuits. Marketed as “a thermostat to restore balance,” Abilify outsold all other major-anti depressants in 2013 and 2014 combined. During this same time frame, the FDA issued warnings to the company noting their pharmacology aid was misleading. Abilify earned U.S. revenue of $7.8 billion between the years of 2011 to 2016. Abilify (aripiprazole) was approved in June 2006 to treat adult schizophrenia and bipolar disorder. It is an antipsychotic medication marketed by a partnership of Bristol-Myers Squibb and Otsuka Pharmaceutical. The drug was also marketed as an “add-on treatment for adults with depression when an antidepressant alone is not enough”. Abilify Lawsuit Abilify and its generics previously listed compulsive gambling as a potential side effect for the antipsychotic drug and its generics. After 14 years of monitoring adverse events, the FDA said the warning was not strong enough. According to Abilify lawsuits, the warning did not reflect the nature of the impulse-control risk. A 2014 study by Thomas Moore of the Institute of Safe Medication Practices, noted that urges were not rare. These include uncontrollable gambling, eating, shopping and having sex. In fact, Moore notes, “If you compare the uncontrollable urges to the risk of suicide among patients who take antidepressant drugs, the rate of uncontrollable urges is much higher.” In addition to the 2014 studies, the Abilify lawsuits note that both Canada and Europe updated their warnings, but the manufacturer (BMS-Otsuka) failed to warn patients of the dangers in the U.S. Why Were Abilify Gambling Warnings Issued in Europe and Canada and Not in the U.S.? This is precisely the question individuals harmed by uncontrollable urges are asking the manufacturers. In the fall of 2012, the European Medicines Agency updated the label of Abilify to transparently add reports of pathological gambling among patients prescribed Abilify, regardless of whether these patients had a prior history of gambling. In November of 2015, Canadian regulators followed suit noting an increased risk of uncontrollable gambling and hypersexuality. The Abilify labeling then added warnings. Despite earlier studies and label changes, Otsuka and Bristol-Meyers-Squibb did not warn the U.S. of the link between Abilify and gambling. Furthermore, the FDA did not change the label until May of 2016, leaving millions of Americans at risk for uncontrollable behaviors. In May 2016, the FDA warned 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 generics). According to the FDA, this compulsive behavior could affect anyone taking the medication. Patients and caregivers need to be made aware of the uncontrollable and excessive urges and behaviors that could occur while taking Abilify. Compulsive Gambling Abilify Lawsuit Thomas J. Moore explained the Abilify and gambling link in layman’s terms in an article published on The Daily Beast. “The drug triggers a pathological urge to gamble constantly, sometimes among persons with no previous interest”. According to Moore, “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.” According to Sean Brazil, one of the individuals filing an Abilify gambling lawsuit, after taking Abilify in 2004, he began compulsive gambling, which lasted for a decade until he finally stopped taking the drug. Brazil said he lost more than $50,000 in gambling as a result of Abilify. Patrick Parks also filed an Abilify lawsuit claiming the drug caused him to lose more than $75,000 while gambling. Parks was a compulsive gambler only while on Abilify from August 2014 until November 2014. When he stopped taking the drug the compulsive gambling stopped. Abilify through one woman’s life into a “tailspin” while she was taking it. She described herself in a “hypnotic state “ and became obsessed with sexual fantasies, thriving for the attention of men. This woman created risqué Facebook pages and sent sexually explicit pictures to her male friends. She kept up a secondary life that also involved excessive shopping sprees until she forced her family into bankruptcy. Abilify Lawsuits – “Off Label” Marketing Bristol-Myers Squibb pushed Abilify as a treatment for kids and for elderly patients with dementia. Neither of these had clinical trial support or FDA approval. As a result of this “off-label” marketing, BMS and Otsuka Pharmaceutical, the co-promoters of Abilify in the U.S. agreed to settlements in excess of $538 million as follows: $515 million in September 2007 paid by BMS and Apothecon to the U.S. Department of Justice for a wide array of allegations including $25 million paid for the off-label marketing of Abilify. The rest of the money was the result of illegal drug pricing schemes $4 million in March 2008 payment by Otsuka – $2.3 million to the federal government and $1.7 million to Medicaid programs in various states. $19.5 million in December 2016 in the same off-label marketing settlement with 42 states.