The Food and Drug Administration’s (FDA) advisory panel is meeting April 8 to determine if AstraZeneca can market Seroquel XR to patients for major depression and anxiety disorders, extending the market share to approximately 20 million more patients. The drug is currently approved for schizophrenia and bipolar disorder.
Unfortunately for consumers, this decision might be made without the full benefit of knowing what AstraZeneca knows about their drug and its potential side effects. Court documents, which the company refuses to make public, contain unpublished clinical trial information and internal conclusions by the company on the increased risk of weight gain and diabetes which were not previously shared with the FDA.
Sealed court records are hiding the dangers of prescription drugs and Seroquel is the latest example of how companies use secrecy agreements to hide product risks and mislead consumers into thinking they are safe,” said American Association for Justice Senior Vice President of Public Affairs Linda Lipsen. “Companies that are unable to hide behind secrecy agreements would be motivated to fix or recall product dangers, preventing consumers from suffering unnecessary injury or death.”
