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The complaint, which was filed Monday along with the settlement, alleges BMS engaged in unfair or deceptive trade practices when marketing Abilify. Abilify is the brand name for the prescription drug aripiprazole. The drug was originally approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in 2002. However, the complaint alleges that BMS promoted Abilify for use in elderly patients with symptoms consistent with dementia and Alzheimers disease. This was done despite the lack of FDA approval for these uses and without first establishing the drugs safety and efficacy for those uses. In 2006, Abilify received a black box warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. Drug manufacturers are prohibited from promoting their drugs for uses that have not been approved by the FDA, General Slatery said. By making false claims and down-playing the risks associated with this drug, the company jeopardized the health of Tennesseans and should be held accountable. The states allege BMS also promoted Abilify for uses in children not approved by the FDA. The complaint states that BMS made false and misleading representations about Abilifys risks and overstated the findings of scientific studies by not revealing limitations that would materially affect the interpretation of the study results. We will continue to work with the State Attorney Generals Office and other partnering organizations to protect Tennessee consumers from unfair and deceptive business practices such as this one, said Director Cynthia Wiel of the Tennessee Division of Consumer Affairs. As part of the $19.5 million settlement, the state of Tennessee will receive $399,022. According to the terms of the settlement: BMS marketing of any formulation containing the active ingredient aripiprazole will be restricted. BMS will be prohibited from making false or misleading claims regarding Abilify, its safety, or efficacy in comparison with other drugs, or the implications of clinical studies relating to the drug.
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