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Seroquel, AstraZeneca, and Off-Label Use


A whistleblower named James Wetta triggered the US government’s lawsuit against UK-based AstraZeneca for allegedly promoting Seroquel for purposes not approved by the Food and Drug Administration (FDA), including dementia in the elderly. While AstraZeneca has agreed to pay $520 million to settle the investigation, the company denies the allegations.

Seroquel (generic, quetiapine) is an antipsychotic medication approved by the FDA to treat schizophrenia in adults and children who are at least 13 years old. It is also approved to treat bipolar disorder (manic depression) in adults and children who are at least 10 years old. The extended-release form (Seroquel XR) is intended for use only in adults and not for anyone younger than 18 years old.

Seroquel is specifically not intended to be used in psychotic conditions associated with dementia, as it may cause sudden death, pneumonia, or heart failure in older adults who have dementia-related conditions. Older patients, especially women, are at risk for developing tardive dyskinesia, a potentially irreversible condition characterized by uncontrollable muscle spasms and twitches in the body and face.

Wetta’s lawsuit against AstraZeneca included allegations that he was told by his employer to promote the use of Seroquel to child and adolescent psychiatrists, primary care physicians, and to elderly patients who had dementia, according to a Wall Street Journal article. AstraZeneca also allegedly promoted off-label use of Seroquel through online educational programs that targeted health professionals, as well as through payments to physicians.

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Once the FDA approves a drug for specific purposes, doctors are free to prescribe it for off-label uses if they deem it prudent. Off-label use has always been a gray area, however, especially when the drugs are associated with serious, even deadly side effects. Pharmaceutical companies and their representatives, however, are supposed to limit themselves to marketing their products for FDA-approved purposes only. To get around this restriction, and thus boost sales, sales reps may, for example, inform doctors that a specific drug is being investigated for another indication that has not yet obtained FDA approval.

Seroquel, like other similar drugs, have an increased risk of suicidal thoughts and actions in children, teenagers, and young adults in their early twenties. All patients who start Seroquel, and their family members and caregivers, should be warned to report any new or worsening symptoms, such as mood or behavior changes, anxiety, panic attacks, insomnia, irritability, agitation, hostility, and thoughts of suicide or harming oneself.

Use of Seroquel is associated with other serious side effects as well, including confusion, uncontrollable jerky muscle movements, sudden numbness or weakness, sudden headache, vision and speech problems, balance problems, fever, stiff muscles, and urination problems. Like other antipsychotic drugs, Seroquel is associated with an increased risk of high blood sugar, which in rare cases can cause coma or death. The drug may also have an impact on cholesterol and triglyceride levels.

According to the Associated Press, AstraZeneca raked in $4.9 billion in sales of Seroquel in 2009, partly because of off-label use. In addition to the $520 million settlement, the pharmaceutical company also faces more than 25,000 product liability lawsuits, with most of them alleging that Seroquel caused diabetes. Who knows what the final price tag attached to these suits will be or, more importantly, what price the patients will continue to pay in terms of the impact on their health and life.

Associated Press
Physicians Desk Reference
Wall Street Journal, April 27, 2010