The Food and Drug Administration said Tuesday it will ask an outside panel of medical experts for advice on whether the agency should extend the use of AstraZenaca PLC’s Seroquel for generalized anxiety and major depression.

 

Currently, the drug is approved for bipolar disorder and schizophrenia. Its label already includes warnings about weight gain and diabetes as well as increases in cholesterol levels. The drug is also known to raise risk for tardive dyskinesia, a disorder causing involuntary, repetitive movement of the limbs and lip smacking, grimacing and other symptoms that can be permanent.

 

Now the FDA wants to discuss with its Psychopharmacologic Drugs Advisory Committee on April 8 whether Seroquel’s risks outweigh its benefits in people suffering from generalized anxiety disorder and major depression.

 

The safety issues at the meeting will focus on “concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinezia,” the agency wrote in a notice on its Web site.

 

AstraZeneca “fully supports the work of the FDA in conducting a full review of the potential benefits and risks of Seroquel XR in the treatment of major depressive disorder and generalized anxiety disorder,” Abigail Baron, a spokeswoman for the company said, adding that the drug is safe and effective when used as recommended.

 

On the other hand, AstraZeneca faces more than 9,000 lawsuits in the US from people who allege the drug caused them health problems including diabetes.