December 9, 2016 — Bristol-Myers Squibb has agreed to pay a $19.5 million settlement with 43 states for marketing the anti-psychotic drug Abilify for unapproved uses.
The settlement places strict rules on how the drug-maker can promote Abilify moving forward, and will prohibit:
- Promotion for “off-label” uses not approved by the FDA
- Using medical grants to promote the drug
- Paying doctors for promotional activities without disclosing their connections
- Making unsubstantiated claims of superiority or effectiveness
Investigators concluded that the drug-maker illegally marketed Abilify for children. The label now warns that Abilify “may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed.”
The company was accused of marketing Abilify to elderly people with dementia and Alzheimer’s disease. Since 2006, Abilify has carried a “Black Box” warning against its use in patients with dementia-related psychosis due to the risk of death.
Antipsychotics are improperly used in some nursing homes to “chemically restrain” hard-to-handle patients. They also double the patient’s risk of stroke and death.