Anti-psychotic drug prescribed to patients to treat Schizophrenia, Bipolar disorder, Major depressive disorder, irritability in Autism spectrum disorder.
History: Otsuka America Pharmaceutical, Inc’s Abilify received FDA approval in 2002 for schizophrenia. In 2007 the FDA approved the drug for major depressive disorder. In 2016 the FDA released a black box warning that Abilify had been linked to compulsive behaviors from lack of impulse control. These behaviors include but are not limited to gambling, hypersexuality, compulsive shopping and binge eating.
In 2007 the justice Department fined Bristol-Myers Squibb $515,000,000 for marketing Abilify to off-market to children, teens, ad elderly dementia patients. In 2016 Bristol-Myers Squibb settled a claim for $19,500,000 for illegally marketing Abilify for off-market uses in 42 states and the District of Columbia.
Settlements have been reached in 3 multi-district litigation cases in the Northern District of Florida. The settlements are for undisclosed amounts. There are currently over 1,000 cases pending in multi-district litigation and about 100 in state courts. The claims are Otsuka and Bristol-Myers Squibb did not provide proper warnings of the risks when using Abilify. The claimants also state the company knew or should have know about the compulsive behaviors the drug can cause.
Related Drugs: Zyprexa, Risperdal, Seroquel
Mild Symptoms: Anxiety, Constipation, Dizziness, Drowsiness, Headache, Increased cholesterol Increased triglycerides, Insomnia, Low white blood cell count, Temperature regulation causing dehydration, Stomach upset, Weakness, Weight gain
Serious Side Effects: Compulsive behavior such as gambling, hypersexuality and shopping, Confusion, Fever, Seizures, Suicidal thinking and behavior, Neuroleptic malignant syndrome a life-threatening reaction that includes: High fever, Confusion, Involuntary muscle movement, Rigid muscles, Variable blood pressure, Sweating, Fast heart rate
Manufacturer: Otsuka America Pharmaceutical, Inc.
