Bristol-Myers Squibb has agreed to a $19.5 million Abilify settlement that resolves allegations that it improperly marketed the antipsychotic drug for use in elderly dementia patients. The company has also agreed to restrict its marketing of other medications that contain aripiprazole.
The Abilify marketing lawsuit was filed in Pennsylvania’s Dauphin County Court of Common Pleas, where the settlement was announced yesterday. Pennsylvania and 41 other states, along with the District of Columbia, were party to the agreement.
“This investigation showed the company made misrepresentations that provided health care providers and patients with misleading information about the approved uses of this drug,” the Pennsylvania Attorney General said in a statement. “This settlement implements a number of meaningful reforms that will protect consumers while preventing this conduct from occurring in the future.”
The states’ lawsuit also charged Bristol-Myers Squibb with improper marketing of Abilify for use in children.
Abilify was approved by the U.S. Food & Drug Administration (FDA) in 2002, and has never been cleared to treat elderly dementia patients. Like all antipsychotics, its labeling includes a boxed warning stating that the drug may be associated with an increased risk of death when used to treat elderly patients suffering from dementia-related psychosis.
Bristol-Myers Squibb denies any wrongdoing. Abilify is manufactured by Otsuka America Pharmaceutical, Inc., and has not been marketed by Bristol-Myers Squibb since 2013.
“We are pleased to put this matter behind us so that we can focus on making transformational medicines for patients battling serious diseases,” a company statement said.
Court documents indicate that dozens of Abilify lawsuits have been filed in U.S. courts on behalf of patients who allegedly developed gambling addictions associated with its use. Recently, federal cases of this nature were consolidated in a multidistrict litigation that is now underway in the U.S. District Court, Middle District of Florida.
This past May, the U.S. Food & Drug Administration (FDA) ordered the manufacturers of Abilify and other aripiprazole products to add new warnings regarding compulsive gambling and other impulse control problems to their product labels and patient Medication Guides. While compulsive gambling had already been mentioned as a possible side effect, the FDA said that the previous labels did not completely reflect the nature of the impulse-control risk associated with the drugs.