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British pharmaceutical giant AstraZeneca is lobbying the US drugs regulator to approve a schizophrenia treatment for use among patients with depression and anxiety disorders.
The Food and Drug Administration (FDA) said it recognises that Seroquel XR does work against depression, though there are concerns about its side effects, including the risk of sudden heart death.
Millions of people with schizophrenia and bipolar disorder already use the drug to help manage their condition, and AstraZeneca now wants the FDA to approve it as a treatment for depression and anxiety disorders.
A panel of outside experts is due to give the FDA its opinion about the consequences of exposing more patients to Seroquel’s side effects, such as weight gain and nervous tics.
FDA drug reviewer Thomas Laughren said: “There remains a concern about longer-term risks with this drug, in particular risks related to metabolic changes.
He also cited a recent article in the New England Journal of Medicine that suggests antipsychotic drugs such as Seroquel can increase the risk of sudden cardiac death.
Aside from these safety concerns, the agency has already concluded that Seroquel is effective at controlling depression based on a number of company studies.
Copyright Press Association 2009