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Bristol-Myers Squibb to pay $19.5M to settle off-label promotion case

Published December 09, 2016

Reuters
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Hand about to bang gavel on sounding block in the court room (iStock)

Drugmaker Bristol-Myers Squibb Co will pay $19.5 million to resolve multi-state allegations that it improperly promoted a schizophrenia treatment for uses not approved by the U.S. government, New York Attorney General Eric Schneiderman said on Thursday.

The company's agreement with 42 other states and the District of Columbia centers on charges that Bristol-Myers Squibb promoted its Abilify anti-psychotic drug for use in children and elderly patients with dementia and Alzheimer's disease.

A company spokesman did not have an immediate comment on the settlement.

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At the time the marketing of the drug occurred, such uses were not approved by the Food and Drug Administration. In 2006, the drug had received a "black box" warning stating that it could increase the risk of death for dementia patients.

Besides addressing the off-label promotion allegations, the settlement also resolves charges that the company violated state consumer protection laws by misrepresenting side effects such as metabolic weight gain.

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