Quoted from http://www.nytimes.com/2011/07/19/health/19drug.html
Heart Warning Added to Label on Popular Antipsychotic Drug
By DUFF WILSON
Published: July 18, 2011
AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.
The revised label, posted without fanfare last week on the F.D.A. Web site, says Seroquel and extended-release Seroquel XR “should be avoided” in combination with at least 12 other medicines linked to a heart arrhythmia that can cause sudden cardiac arrest.
Sandy Walsh, a spokeswoman for the F.D.A., said the statement was only a precaution for doctors, and should not be considered a complete ban against prescribing Seroquel with the other drugs.
Ms. Walsh said the label was changed after the F.D.A. received new information about reports of arrhythmia in 17 people who took more than the recommended doses of Seroquel. Though it should not be a problem at a normal dosage, she said, it may still be good advice to avoid using the drugs together.
The arrhythmia, known as prolongation of the QT interval, referring to two waves of the heart’s electrical rhythm, is estimated to cause several thousand deaths a year in the United States.
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