Abilify

Abilify information
Abilify (aripiprazole) is an atypical antipsychotic that is approved to treat a number of psychiatric conditions in adults and children. The medication, which is marketed by Bristol-Myers Squibb and the Otsuka Pharmaceutical Company, was initially approved by the U.S. Food & Drug Administration (FDA) in 2002. Several studies have suggested that Abilify may be associated with compulsive behavior, including gambling addictions. A growing number of Abilify lawsuits allege that Bristol-Myers Squibb and Otsuka failed to provide patients and doctors with adequate warnings about this risk.

Abilify Lawsuit Reviews

The nationwide law firm of Bernstein Liebhard LLP is now offering free legal reviews to individuals who allegedly developed a compulsive gambling habit while using Abilify. To learn more about your legal options, please contact our Firm at (888) 994-5118.

What is Abilify?

In 2013, Abilify was the top selling drug in the U.S., with sales over $6.4 billion. The medication works by increasing or decreasing dopamine or serotonin in the brain. These two neurotransmitters produce feelings of pleasure and motivation.

The FDA has approved Abilify for the following indications:

  • The treatment of schizophrenia in adults and adolescents
  • The acute treatment of manic and mixed episodes associated with bipolar I disorder in adults and children
  • Maintenance treatment of bipolar I disorder
  • Adjunctive therapy to antidepressants for the treatment of major depressive disorder
  • Irritability associated with autistic disorder in pediatric patients

Abilify is sometimes prescribed for off-label uses like anxiety, obsessive-compulsive behavior, irritability and aggression

According to a report published in July 2016, Abilify ranked  as Medicaid’s costliest drug in aggregate from January 2014 to June 2016. Aggregate drug costs reflect both frequency of use and per prescription cost. Read More

Abilify Side Effects and Complications

Serious side effects that may occur with Abilify include:

  • Increased risk of death in elderly patients with dementia-associated psychosis.
  • Risk of suicidal thoughts and actions

Common Abilify side effects that require medical attention include:

  • Speaking difficulties
  • Drooling
  • Loss of balance control
  • Trembling, jerking, or stiffness in the muscles
  • Restlessness
  • Shuffling walk
  • Limb stiffness
  • Twisting movements of the body
  • Uncontrolled movements, especially of the face, neck, and back

More information about the side effects and complications potentially associated with Abilify can be found in the drug’s Medication Guide.

Abilify Marketing Settlements

  • In September 2007, Bristol-Myers Squibb entered into an agreement with the U.S. Department of Justice (DOJ) to pay $515 million to settle civil charges involving Abilify and other medications. Among other things, federal prosecutors had alleged that from 2002 through the end of 2005, the company knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis. The medication has never been approved to treat elderly dementia patients. When the settlement was announced, it had yet to be approved for any pediatric indications.
  • In March 2008, Otsuka Pharmaceutical agreed to a $4 million Abilify settlement in order to resolve similar charges with the DOJ.

Studies Link Abilify and Compulsive Gambling

Dopamine is a neuro-transmitter that is associated with feelings of pleasure, as well as addictive or compulsive behaviors. Some research has indicated that Abilify may over-stimulate dopamine reward receptors in the brain – called dopamine 3 (D3) receptors – causing some patients to experience compulsive behaviors, including pathological gambling.

  • February 2011: A study detailed three patients who developed compulsive gambling habits while using Abilify to treat schizophrenia or schizoaffective disorder. None of the patients had a prior history of pathological gambling, and their compulsive behavior began after they initiated treatment with Abilify.
  • April 2011: A paper that appeared in the British Journal of Psychiatry reported on three more cases of compulsive gambling among Abilify patients.
  • March 2014: Eight more cases of pathological gambling possibly associated with Abilify were reported in the journal Addictive Behavior.
  • October 2014: JAMA Internal Medicine reported on 37 cases of gambling addiction in Abilify patients.

Impulsive Behavior Warning Added to Abilify Label

In May 2016, the FDA added stronger warnings to the Abilify label regarding a possible association with compulsive gambling and other impulsive behaviors, including binge eating, compulsive shopping, and sexual action.  A review conducted by the agency had uncovered scores of case reports in which there was an association between aripiprazole use and impulse-control problems. The majority of reports involved patients with no prior history of impulse control issues, and in which the behavior stopped once treatment with the drug cease or dosage was decreased. Read More

  1. FDA (2013) “Medication Guide – Abilify” http://www.fda.gov/downloads/drugs/drugsafety/ucm085804.pdf
  2. DOJ (2007) “Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing” http://www.justice.gov/archive/opa/pr/2007/September/07_civ_782.html
  3. DOJ (2008) “Otsuka to Pay More than $4 Million to Resolve off-label Marketing Allegations Involving Abilify” http://www.justice.gov/archive/opa/pr/2008/March/08_civ_244.html
  4. NCBI (2011) “Aripiprazole-induced pathological gambling: a report of 3 cases” http://www.ncbi.nlm.nih.gov/pubmed/21241242
  5. British Journal of Psychiatry (2011) “Pathological gambling and the treatment of psychosis with aripiprazole: case reports” http://bjp.rcpsych.org/content/199/2/158.full
  6. Addictive Behavior (2014) “Aripiprazole: a new risk factor for pathological gambling? A report of 8 case reports.” http://www.ncbi.nlm.nih.gov/pubmed/24315783
  7. JAMA Internal Medicine (2014) “Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated With Dopamine Receptor Agonist Drugs” http://archinte.jamanetwork.com/article.aspx?articleid=1916909

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Last Modified: August 4, 2016

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