Seroquel Documents Show Drug Maker Discussed Promoting Off-Label Uses, Plaintiffs' Lawyers ClaimMay 20, 2009 | Parker Waichman LLP
Lawyers for people suing Seroquel maker AstraZeneca will charge today that executives at the company discussed promoting the off-label use of the drug in children and elderly patients. immediate demand
Seroquel - which was introduced in 1997 - is approved to treat psychotic disorders, schizophrenia and bipolar disorder. AstraZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the antipsychotic drug’s diabetes risk.
Off-label uses are those that have not been approved by the Food & Drug Administration (FDA). Doctors are permitted to use any approved drug in any way they see fit, but drug makers are legally barred from promoting off-label use.
According to The Wall Street Journal, there has been no evidence that off-label Seroquel use was promoted by AstraZeneca. But at today's news conference, attorneys will present evidence they claim show the company discussed doing so.
That evidence includes internal documents that cited plans to "broaden Seroquel use on and off-label," including among adolescents and patients with Parkinson's and Alzheimer's disease, at medical meetings, in sales calls and with patient-advocacy groups," the Journal said.
In one 2001 public relations plan reviewed by the Journal, one of the stated objectives was to "encourage and support" Seroquel's "use outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly". The same document also said there was a need for "aggressive market penetration" among adolescents, the elderly, patients with bipolar disorder and other groups for Seroquel to grow faster than rivals, the Journal said.
Atypical antipsychotics like Seroquel are favored by many doctors and patients because they carry a decreased risk of side effects related to loss of motor control, a major problem with older “typical” antipsychotics.
But Seroquel and similar drugs carry other safety risks. For instance, these drugs have long been linked to a risk of weight gain and diabetes, and in 2003, the FDA required the makers of atypical antipsychotics to re-label them to include warnings regarding their risk of hyperglycemia and diabetes mellitus. In 2005, the FDA also warned that such drugs increased the risk of death among elderly people.
According to The Wall Street Journal, an AstraZeneca official denied that any of the documents indicate a desire on the part of the company to promote off-label uses of Seroquel. Rather, the documents indicate the company's plan to "explore additional indications for Seroquel and included that in clinical-development plans designed to support efforts to investigate potential additional indications," the spokesperson said.