AstraZeneca Pharmaceuticals will pay North Carolina and 37 other states $68.5 million to resolve allegations that it improperly marketed the drug Seroquel, said Attorney General Roy Cooper.“It’s dangerous to push medications as treatments for conditions they haven’t been proven to treat,” Cooper said. “Patients and doctors deserve accurate information about drugs, not to be misled by tricky marketing.” Cooper and attorneys general for the other states allege that AstraZeneca engaged in unfair and deceptive practices when it marketed Seroquel for unapproved or off-label uses. For example, the company is accused of promAoting the drug for use by children and seniors, specifically in nursing homes for Alzheimer’s and dementia, as well as to treat anxiety, depression, sleep disorders, and post traumatic stress disorder. However, the drug had not been approved to treat these conditions or approved for children and seniors. The attorneys general also contend that AstraZeneca failed to adequately disclose potential side effects to health care providers and withheld negative information from scientific studies about Seroquel’s safety and efficacy.North Carolina served on the executive committee that helped negotiate the settlement and will receive $2.4 million of the $68.5 million paid to the states. This is the largest ever consumer protection settlement involving a pharmaceutical company, trumping a 2008 settlement where Eli Lilly paid $62 million to resolve allegations about the drug Zyprexa.Following a three year investigation by the states, AstraZeneca has agreed not to promote Seroquel in a misleading manner including for off-label uses, uses which have not been approved by the U.S. Food and Drug Administration. Although doctors are allowed to prescribe drugs off-label, pharmaceutical manufacturers are prohibited by law from marketing their products for off-label uses.
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