The Food and Drug Administration said yesterday it will consider a request to restrict use of the intravenous sedative Versed, which has been linked to several deaths.
But an agency spokesman said the FDA thinks that new warnings now accompanying the drug are effective in preventing its misuse.
Versed is widely used for so-called conscious sedation for many diagnostic procedures such as cardiac catheterization in which the patient does not need to be fully anesthetized. Such tests frequently are done in doctors' offices.
Versed, made by Hoffmann-La Roche Inc., is also used in larger doses in operating rooms where full anesthesia is required.
The Public Citizen Health Research Group petitioned the FDA yesterday to state that Versed should not be used on people 60 years of age or older for conscious or unconscious sedation, and should not be used on anyone for conscious sedation. It cited FDA records in which 40 deaths were reported to the agency as possibly linked to use of Versed since it was approved just over two years ago.
Faye Petersen, a spokesman for the FDA, said the agency had not had a chance to review the petition. But, she said, "It will receive our prompt and careful attention."
She added that the FDA has evaluated reports of adverse reactions in the drug's early use, including some deaths, and those reviews found that the cases involving deaths were complicated and that it was hard to pin down the impact of Versed.