A U.S. Food and Drug Administration (FDA) committee recommended approval of Seroquel as an add-on therapy for patients with depression, but said the drug shouldn’t be used alone because of concerns about side effects. The committee recommended its use for patients who don’t adequately respond to their current medications.
The government panel made the recommendation after a day’s long emotional meeting that included stories from two families who say their loved ones died after taking the medication.
Recommending a broader use of the medication would have dramatically expanded the market for Seroquel. The drug is currently approved to treat schizophrenia and bipolar disorder, relatively rare diseases, and generates $4.47 billion in yearly sales.
“It’s certainly going to help their bottom line, but it’s not the great victory they had hoped for,” said Daniel Carlat, a Tufts University psychiatrist who was not on the advisory panel. He said companies can use such narrow approvals to market a drug more widely.
The panel also rejected the drug for use as a treatment for generalized anxiety disorder, a condition marked by excessive worry and chronic anxiety, without reason, about a number of everyday situations.
The panel decisions, which were made in a series of votes, are recommendations, and the FDA later will make a decision whether to expand use of Seroquel.
The panel said Seroquel should only be considered as an additional depression treatment after other drugs fail. Depression is believed to affect 15 million Americans.
Seroquel, currently approved to treat schizophrenia and bipolar disorder, is the company’s second-best-selling drug with $4.45 billion in sales in 2008. The company is seeking broader use of its extended-release version of Seroquel.
The FDA called a meeting of its psychopharmacologic advisory panel to discuss “concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia,” a neurologic disorder that can be caused by drug exposure. The company is facing more than 9,000 lawsuits in the U.S. from people who allege the drug caused various health problems such as diabetes.
Thomas Laughren, the director of FDA’s division of psychiatry products, said the company showed Seroquel was effective at treating major depression and generalized anxiety disorder. But he said the agency wanted advice about “the public health implications” of what likely would be “greatly expanded use of the product.”
In background memos prepared for the meeting, the FDA said “there’s accumulating evidence” that Seroquel may have “substantial metabolic risk,” such as weight gain and impact on blood glucose and lipids that in turn can cause cardiovascular problems and diabetes.
The agency said tardive dyskinesia is an acceptable risk in schizophrenic and bipolar patients but the risk becomes “even more important” with the possibility of wider use of drugs that are linked to the side effect.
Laughren also said the agency is also concerned about the possibility that drugs like Seroquel could increase the risk of sudden cardiac death as was suggested in a recent research paper in the New England Journal of Medicine.
AstraZeneca officials told the panel there’s no evidence Seroquel increases the risk of sudden cardiac death but said they were planning additional long-term studies to look at cardiovascular and diabetes risks.
Source: Wire News Sources