WASHINGTON (Reuters) - U.S. regulators said on Monday that Johnson & Johnson added new warnings to its schizophrenia drug, Haldol, about the potential risk of death and of dangerous heart conditions observed in some patients.
The U.S. Food and Drug Administration said new labeling on the drug will note that ailments, including QT prolongation, a disorder of the heart’s electrical system that can lead to a life-threatening condition, have been observed in post-marketing studies.
The drug is also sold generically under the name haloperidol.
Several other drugs for schizophrenia, including a much newer J&J drug including Invega, have warnings about the risk of the serious cardiac effect.
The FDA, in a posting on its Web site, said the new labeling comes after a number of case reports of sudden death and QT prolongation in patients treated with the drug. In most cases, patients had taken higher-than-recommended doses or were given the drug intravenously, which is not an FDA approved method of use, the FDA said.
The FDA said the case studies came from research J&J was asked to do by Italy’s regulatory drug agency.
J&J spokeswoman Ambre Morley said the company has made the requested label changes.
Reporting by Kim Dixon