Attorneys that represent plaintiffs in a lawsuit against the drug manufacturer AstraZeneca, maker of the anti-psychotic Seroquel, planned yesterday to release documents that show that executives in the company discussed promoting the off-label use of Seroquel in children and elderly patients. While there is no evidence that AstraZeneca actually promoted the off-label use of Seroquel, the plaintiffs’ attorneys charge that internal documents show that executives had plans to “broaden Seroquel use on and off label” including among patients with Parkinson’s and Alzheimer’s disease. The same documents also show that executives said that there was a need for “aggressive market penetration” among adolescents, the elderly, and patients with bipolar disorder and other groups in order for Seroquel to grow faster than rivals.

Seroquel was introduced in 1997 to treat psychotic disorders, schizophrenia, and bipolar disorder. Many doctors liked to prescribe Seroquel over other antipsychotics because it has a decreased risk of side effects related to loss of motor control, which many other antipsychotics carry. Seroquel does have its own safety risks, however. The drug has long been linked to weight gain and diabetes, and in 2005 the FDA issued a warning that Seroquel, among other drugs, was linked to death in the elderly. Currently AstraZeneca, the manufacturer of Seroquel, faces over 9,000 lawsuits filed by people who claim that the company withheld information about the antipsychotics’ diabetes risk. AstraZeneca deny that the documents held by the attorneys indicate a desire by AstraZeneca officials to promote off-label uses.

For more information, visit the Wall Street Journal’s online article:
http://online.wsj.com/article/SB123570604586190627.html
For the FDA’s warning, visit: http://www.fda.gov/cder/drug/InfoSheets/HCP/quetiapineHCP.htm

Labels: antipsychotic, drugs, FDA, quetiapine, Seroquel, warning