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Bristol-Myers Squibb has agreed to pay $19.5 million to settle claims involving illegal marketing of the antipsychotic drug Abilify, resolving claims brought by more three dozen states.
The Abilify settlement agreement, which involves payments to 41 states and the District of Columbia, was announced on Thursday by a number of state attorneys general. It resolves claims that the manufacturer promoted Abilify for uses that were not approved by the FDA, which is known as off-label marketing.
While it is legal for doctors to prescribe an approved medication for any reason they see fit, it is illegal for drug manufacturers to promote their products for uses that were not determined by the FDA to be safe and effective.
According to charges brought by the states, Bristol-Myers Squibb illegally promoted Abilify, an atypical antipsychotic, for pediatric use and for use in treating dementia and Alzheimer’s disease. The charges also indicated that the company had downplayed the potential risk of Abilify side effects, such as weight gain and compulsive behavior, to the medical community and patients.
“Drug companies should not market their drug for off-label uses or make claims that are not supported by the scientific evidence,” New York Attorney General Eric Schneiderman said in a press release announcing the settlement. “Consumers must be able to rely on their doctor’s advice for medication without having to worry about drug companies manipulating their advertising to promote their products at the expense of patients.”
Abilify (ariprazole) is one of the top-selling brand name medications on the market in the United States, generating sales in excess of $6 billion per year. It was introduced in 2002 for treatment of schizophrenia, bipolar disorder and other major depressive disorders, but is also widely used to treat irritability, aggression, mood swings and other behavior issues.
In May, the FDA required the drug makers to update the warning label to provide information for users and doctors about the potential Abilify risk of gambling, compulsive shopping and other compulsive activities. The regulatory agency noted that a large number of adverse event reports have been received from users describing uncontrollable urges to gamble, shop, eat or engage in sexual activity.
Since then, the manufacturer has faced a growing number of Abilify lawsuits over compulsive behaviors such as gambling, binge eating and sex addiction.
Addictive gambling problems on Abilify can have a severe impact on users, causing severe financial losses and behavior that can destroy families, reputations and cause irreparable damage to an individual’s quality of life.
Plaintiffs allege that if warnings had been provided about the risk of impulsive behaviors, they may have avoided devastating consequences by recognizing the potential side effects associated with the medication and stopping use of the drug.
Although warnings about the potential risks were provided to medical providers and consumers outside the United States, plaintiffs in the mounting Abilify litigation claim that similar information was withheld in the United States until recently.
The settlement agreement with the states is expected to have no bearing on individual Abilify personal injury claims filed by those who used the drug.