The U.S. Food and Drug Administration recently urged drug manufacturer, AstraZeneca, to update the label of its blockbuster anti-psychotic medication, Seroquel, following the agency’s receipt of almost 17 individual reports from patients experiencing heart problems as a result of taking more than the recommended dose of the drug.
Following the FDA’s request, AstraZeneca released a statement that it would, in fact, add a warning to the drug’s label about the risk of potentially life-threatening heart rhythm problems when combined with certain other medications, as well as when taken in excess.
Seroquel is a popular anti-psychotic medication approved for use in the treatment of schizophrenia, bi-polar disorder and severe depression. The drug is a top-selling product for AstraZeneca, generating more than $5 billion in sales last year. Seroquel is often prescribed for off-label uses not previously approved by the FDA, such as autism, compulsive disorders and obsessive dementia. It has also been the subject of heated legal battles over the years, one of which resulted in a $520 million settlement pay-out by AstraZeneca, following government claims the company was engaging in illegal marketing activities.