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March 15, 2011 > Settlement over deceptive marketing of Seroquel

Settlement over deceptive marketing of Seroquel

Submitted By California Attorney General's Office

California Attorney General Kamala D. Harris and 37 other attorneys general have reached a $68.5M settlement with AstraZeneca Pharmaceuticals for unfair and deceptive practices in its marketing of the antipsychotic drug Seroquel.

As part of the largest multi-state settlement with a pharmaceutical company in history, announced on March 10, California will receive more than $5.2M, the largest share among the states in the consumer protection case.

"The health and well-being of patients should drive drug prescriptions in California, not the profits of a pharmaceutical company," said Harris. "This settlement puts an end to unscrupulous marketing practices and protects consumers from misguided, and potentially dangerous, treatment with Seroquel for uses the Food and Drug Administration (FDA) has not approved."

The complaint alleges that AstraZeneca promoted Seroquel for unapproved uses, failed to adequately disclose potential side effects to health care providers and withheld scientific studies that called into question the drug's safety and efficacy.

Seroquel is an antipsychotic medication used to treat schizophrenia and bipolar disorder. It was approved by the FDA for treatment of these conditions in adults but AstraZeneca promoted the drug for children and the elderly to treat a variety of medical conditions, including anxiety, depression, post traumatic stress disorder, Alzheimer's disease and dementia.

Doctors may prescribe medications for unapproved or "off-label" uses but drug makers are prohibited from promoting drugs for treatment of medical conditions not approved by the FDA.

A three-year investigation, led by the attorneys general of Florida and Illinois, revealed AstraZeneca also failed to adequately disclose side effects associated with Seroquel, including weight gain, hyperglycemia, diabetes and cardiovascular complications.

As part of the settlement, AstraZeneca agreed to not promote Seroquel in a false, misleading or deceptive manner, including for "off-label" uses. The drug maker is required to provide accurate and scientifically balanced responses to requests about off-label usage. AstraZeneca is also required to enact policies to ensure financial incentives are not given to salespeople for off-label marketing and post payments made to physicians on a website.

States joining California and the District of Columbia in the settlement include Arizona, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

Copies of the related documents are at www.ag.ca.gov.

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