AstraZeneca’s Seroquel Faces Legal Fight over Presumptive Adverse Effects

[This article posted on March 1, 2009. It is posted within the following categories: Pharma & Devices, Politics & The Law, via Michael Douglas, MD, MBA.]

The association between certain newer antipsychotic drugs and glucose intolerance, a pre-diabetic state, has always been the bane of patients, their prescribers — let’s not forget — the poor, hapless pharma manufacturers which market them. Time to give Pfizer and its blockbuster Zyprexa a break and now place the focus on AstraZeneca and its huge seller, Seroquel. Otherwise known by its generic name, quetiapine, Seroquel has always enjoyed a reputation of crossover utilization between psychiatry and primary care; this is due to its versatility in treating both psychosis and lesser “acute” states: everything from an FDA indication of bipolar disorder to the mundane diagnosis of primary insomnia. All of this and a low potential for psychological dependence, to boot.

This extreme breadth of written prescription power at the hands of multiple specialties and the drug’s perceived versatility has made it a solid perfromer for AstraZeneca on Wall Street. Although the potential for the patients who take Seroquel to develop overt diabetes mellitus is definitely more than theoretical, the bad press its congener cousin Zyprexa has received over the issue has created and maintained the spectre of Seroquel’s relative safety among prescribing healthcare professionals. That is…until now. At issue is whether the pharma company purposefully withheld information from the public with regard to health risks similar to those known to have been caused, in part, by antispychotic medications like Zyprexa. The plaintiffs claim Seroquel caused diabetes, weight gain and related health problems, from kidney failure and heart attacks to amputations and damage to the pancreas, which makes insulin.

Meanwhile, AstraZeneca said recently that the FDA has asked for additional information about the safety and effectiveness of a newer version of the drug, the newly patented Seroquel XR extended release tablets. That version is approved for schizophrenia and bipolar disorder, but the company is seeking approval to market it for anxiety and major depression. To the pharma company, such a move to extend a patent is either one of hubris or simple denial. | LINK

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