Abilify and Gambling Addiction

Have you or a loved one ever used Abilify?  Did you or a loved one develop a gambling addition while using this medication? If so, you may be entitled to financial compensation.

What is Abilify?

Abilify (aripiprazole) is an atypical anti-psychotic medication of the drug class known as partial dopamine receptor agonists. It is used to treat various mental health conditions, such as bipolar disorder, major depression, mood swings, irritability, aggression, schizophrenia and other behavior issues.

The drug works by affecting dopamine levels. Dopamine is a neurotransmitter that helps regulate feelings of motivation and pleasure. It’s typically “activated” by the body’s “reward system” in ways that reinforce certain behaviors.

Introduced to the market in 2002 and made by Bristol-Myers Squibb (BMS), it was the company’s bestselling drug in 2013, generating $2.3 billion in sales. In 2014, Abilify generated $417 million in sales, just in the United States, from April to June. Worldwide sales during the second quarter of 2015 were $555 million.

What is the Problem with Abilify?

Studies have shown a possible connection between impulse control problems and Abilify use. The same possible connection has been show with other drugs in this class. Worse, it appears that BMS either knew or should have known that Abilify could increase the risk of loss of impulse control and result in compulsive, addictive gambling. Yet, the company hid this information from doctors and patients worldwide all in the name of profits.

Scientists have known about the increased risk of impulse control problems, such as gambling addiction, with Abilify use for years – since approximately 2005. Multiple studies have linked the drug with gambling addiction.

In 2009, a small study of Parkinson’s patients being treated with dopamine receptor agonists at the Mayo Clinic showed abnormally high rates of impulse control problems among those patients. The problems included compulsive gambling, hypersexual behavior or both together.

The British Journal of Psychiatry published three case reports in April 2011 detailing such problems:

  •  “[J] was pre-occupied with thoughts of gambling and his gambling activity became both impulsive and involved extensive planning in obtaining funds to gamble, including the use of crime.”
  • “[K] described an escalation in his gambling to the extent of spending all of his money and it being ‘a reason to live’.”
  • “[S] began experiencing strong urges to gamble in the form of a euphoric feeling when thinking about gambling. In the following 2 years he incurred debts of around £25,000 on internet betting sites.”

Again, in October 2014, a study possibly connecting Abilify use and impulse control problems, particularly gambling addictions, was published in the Journal of the American Medical Association.

Yet, Bristol-Myers Squibb remained silent on the matter. No adequate warnings came from BMS and many people, trusting that the medication would help them, instead ended up experiencing long-term damage and heavy losses – financial and otherwise – because they didn’t have the information needed to get help.

Profits before Patients

U.S. scientists have been asking the FDA for a Black Box warning label highlighting the risk of gambling addiction and other impulse control problems on dopamine agonists, such as Abilify. Their requests have fallen on deaf ears until recently. However, such was not the case in Europe and Canada.

In 2012, the European Medicines Agency (EMA) required a New Abilify Warning Labelfor Abilify that highlighted the connection between Abilify use and “pathological gambling.” The EMA based this requirement on post-marketing studies showing 19 cases of such behavior in those taking the drug. Interestingly, most of these cases met the U.S. FDA’s criteria for “serious” problems.

Abilify sold in Europe has the following warning on its label:

Post-marketing reports of pathological gambling have been reported among patients prescribed ABILIFY, regardless of whether these patients had a prior history of gambling. Patients with a prior history of pathological gambling may be at increased risk and should be monitored carefully.”

Not long after, in 2015, Health Canada stepped in and issued an updated warning for Abilify. This new warning was based on information showing an increased risk of gambling addiction and other impulse control issues.

Abilify sold in Canada has the following warning on its label:

“Post-marketing reports of pathological gambling have been reported in patients treated with ABILIFY. In relation to pathological gambling, patients with a prior history of gambling disorder may be at increased risk and should be monitored carefully.”

It’s no coincidence that Health Canada’s safety review stated that compulsive behaviors in patients on Abilify were either eliminated or improved when the patients ceased taking the drug or reduced their dosages. These changes were found in 14 out of the 18 compulsive gambling cases studied and 5 out of the 6 hypersexual behavior cases.

U.S. Response

Despite the new warning labels in Europe and Canada and all the studies supporting the changes, Abilify labels in the U.S. still said nothing about gambling addiction or pathological gambling. In fact, the U.S. label didn’t even mention the word “gambling” at all until August 2016.

Could the FDA claim ignorance in this matter? It most emphatically could not. The agency got reports of 54 cases of impulse control issues in Abilify patients – 32 of which were of compulsive gambling – between 2005 and 2013. Twenty-nine cases of gambling addiction related to Abilify use were reported to the FDA in 2014, while 153 such reports were submitted in the first half of 2015.

The new U.S. label, issued in Abilify August 2016 warning, contains stronger warning about impulse control issues, such as:

  • Health care providers should ask Abilify patients if they’re experiencing new or intense urges to gamble, have sex, eat or shop.
  • Those taking Abilify may not be able to tell that their compulsive behaviors are out-of-the-ordinary.
  • Abilify users who are having impulse control issues should cease taking the drug or have their health care providers reduce their dosage. Quite often, the compulsive urges stop.

 

What Damages Have Abilify Users Suffered?

Patients being treated with Abilify have suffered various losses, including:

  • Great financial losses (gambling debts)
  • Legal problems
  • Job loss
  • Loss of family (divorce)
  • Decline in quality of life
  • Loss of reputation
  • Emotional damage

Abilify, the Department of Justice, Illegal Marketing & a Multi-million Dollar Settlement

A Department of Justice press release in September 2007 detailed how Bristol-Myers Squibb told its sales representatives to promote Abilify for children, adolescents and the elderly. Despite an FDA-ordered black box warning against using Abilify to treat dementia-related psychosis, BMS’ sales reps targeted nursing homes to increase sales.

The DOJ stepped in regarding BMS’ marketing Abilify for children from 2002 to 2005. Due to this improper marketing, BMS settled with the DOJ for $515 million.

Abilify Lawsuits Centralized in Multi-District Litigation

The numerous Abilify lawsuits were centralized in the U.S. District Court for the Northern District of Florida, Judge M. Casey Rodgers presiding. This Abilify MDL will increase the efficiency and reduce the expense of pre-trial matters, such as discovery, for the parties. The MDL is #2474.

Don’t Wait! The Time is now to Seek Legal Assistance!

If you or a loved one has taken Abilify and experienced any of the negative impacts mentioned, you need experienced pharmaceutical attorneys on your side. The team at Justinian and Associates has years of experience dealing with cases like Abilify. They are also experienced in handling MDL’s. Call today for a free case review before it’s too late. The statute of limitations (how long you have to file a case) may already be counting down. Don’t let it expire! Act now!