It's a double whammy for AstraZeneca in the news today. First, the FDA cited the drugmaker for promoting its antipsychotic drug Seroquel as a remedy for depression -- an unapproved use. Next comes the revelation that AstraZeneca knew that Seroquel could cause diabetes as far back as 2000, long before the company warned doctors about that risk.
According to the FDA, an AstraZeneca sales rep told a doctor that Seroquel could be used to treat major depression, and the doc asked for proof. So the company mailed a packet of info supporting Seroquel as an antidepressant. FDA says that mailing creates a new "intended use" for Seroquel, even though the info packet included a disclaimer saying AstraZeneca didn't recommend the drug for unapproved uses. That disclaimer wasn't enough to counteract the rest of the material, which did promote the unapproved use, the agency said. AstraZeneca says it's taking he allegations seriously and conducting an internal investigation to see what happened.
Meanwhile, court documents presented in a Florida case appear to show that AstraZeneca had evidence of Seroquel's potential to cause diabetes very early on. After a review of Seroquel studies and internal trials, the company's global safety officer concluded that there was "reasonable evidence" that Seroquel could cause diabetes, the documents show. But the company didn't warn doctors of that risk until required by the FDA in September 2003.
- check out the FDA's letter to AZ
- see Pharmalot's post on the antidepressant issue
- read Pharmalot's entry about the diabetes risk