Seroquel Problems Should Prevent Approval for Anxiety and Depression

An FDA advisory panel met last week to consider whether to recommend that approval be granted for AstraZeneca to market their atypical antipsychotic Seroquel XR for wider uses like depression and anxiety. However, due to concerns about exposing millions more people to potential Seroquel problems like diabetes, weight gain, pancreatitis and tardive dyskinesia, the panel did not recommend the drug be used as a first-line treatment for either condition.

AstraZeneca currently faces thousands of Seroquel lawsuits filed on behalf of users who have suffered side effects from the drug. The complaints allege that AstraZeneca failed to fully inform the FDA, doctors and the public about the risks associated with the drug, placing profits before patient safety.

After a new extended release version of their drug, Seroquel XR, was approved last year for treatment of schizophrenia and bipolar disorders, AstraZeneca has been seeking to gain approval to market the drug for even wider uses like depression and anxiety related disorders.

>>PRIOR POST (10/20/2008): Seroquel Use Expanded Despite Side Effects

If AstraZeneca is given what it is looking for, the market for Seroquel could expand from the approximately 8 million people to nearly 30 million people.

Although the FDA panel of outside experts found that Seroquel XR is an effective treatment of major depressive disorder and generalized anxiety disorder, they did not recommend that AstraZeneca be permitted to market the medication as a monotherapy for either condition. However, they did vote 6 to 3 that Seroquel XR was safe enough to be used as an adjunctive treatment for major depressive disorders where other drugs do not provide symptom relief.

The FDA panel’s chairman, Dr. Wayne Goodman, who is also a psychiatric researcher at the U.S. National Institutes of Health, said that he saw no clear advantage in the efficacy of Seroquel when compared to other available drugs for first-line treatment of depression and anxiety, and he was concerned about the Seroquel side effects unintended consequences with wider use of the drug.

The ball is now in the FDA’s court to make a decision about AstraZeneca’s request to market the drug for depression and anxiety. Although the FDA is not required to follow the recommendations of their advisory panels, they usually do and in this case they definitely should.

SEROQUEL ATTORNEYS

The product liability attorneys at Saiontz & Kirk, P.A. are continuing to review potential lawsuits throughout the United States for individuals who have experienced Seroquel problems. AstraZenca’s failure to provide adequate warnings about side effects of Seroquel, such as diabetes, pancreatitis and tardive dyskinesia, have caused many patients to take the drug when they would have elected other therapies if the risk had been known.

If you, a friend or family member have suffered problems, request a free consultation with our Seroquel attorneys.