Drugmaker AstraZeneca launched a public relations push to get doctors to prescribe its best-selling psychiatric drug Seroquel for uses that were not approved by safety regulators, according to a damning internal document.
The drugmaker is being sued by 16,000 patients in the U.S. for "spinning, skewing and concealing" information on the drug's potential side-effects, which can include diabetes and weight gain. In the course of the lawsuit, lawyers unearthed emails and strategy documents showing what they say are repeated violations of the law.
The FDA carefully sets out what claims can be made for every drug, and controls the exact wording of the drug's label. Companies promoting products for unapproved uses can face large fines. But a public relations strategy document emailed around the company said that "communications will focus on increasing the existing off-label usage of Seroquel in [bipolar disorder], estimated to account for around 20 per cent of current prescriptions and growing strongly." Salesmen were also targeting doctors who specialized in treating children, despite the fact that Seroquel has never been approved for use by minors.