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AstraZeneca to pay $68.5 million in Seroquel settlement

March 10, 2011 | 11:40 am

California Atty. Gen. Kamala D. Harris on Thursday announced a $68.5-million multistate settlement with AstraZeneca Pharmaceuticals after the states sued the company for allegedly using unfair and deceptive marketing practices for its antipsychotic drug Seroquel.

The settlement will amount to more than $5.2 million for California and will be added to the state’s consumer protection fund and used to cover litigation costs. The settlement will be shared by 36 other states and the District of Columbia.

The complaint alleged that London-based AstraZeneca promoted Seroquel, which is used to treat schizophrenia and bipolar disorder, for unapproved uses, failed to properly disclose potential side effects and withheld studies that questioned the safety and effectiveness of the drug.

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

Seroquel was approved by the Food and Drug Administration for treatment of schizophrenia and bipolar disorder in adults, but AstraZeneca allegedly promoted the drug for children and the elderly and for a variety of unapproved conditions, including anxiety, depression, post traumatic stress disorder, Alzheimer’s disease and dementia.

Doctors can prescribe medications for unapproved uses, but pharmaceutical companies are prohibited from marketing drugs for “off-label” uses that are not approved by the Food and Drug Administration, according to the attorney general’s office.

The three-year investigation was led by the attorneys general of Florida and Illinois and found that the company also failed to properly disclose possible side effects, including weight gain, hyperglycemia, diabetes and cardiovascular complications.

"We deny the allegations. AstraZeneca believes that it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” the company said in a statement.

Under the settlement, AstraZeneca agreed to not market the drug in a misleading manner or for unapproved uses and is required to provide accurate responses to requests about off-label usage. The company must also enact policies to ensure that no financial incentives are given to sales representatives for unapproved marketing and must post payments made to physicians on a website.

Last April, the company reached a $520-million settlement with the U.S. government, also resolving allegations that the company marketed Seroquel for off-label uses. Under the settlement, California received $31 million.

-- Stephen Ceasar