FDA posts first quarterly drug safety report
WASHINGTON The Food and Drug Administration has posted its first quarterly report on drugs under review for possible safety issues, the agency announced Friday.
The drugs are identified based on a review of reports in the FDA’s Adverse Event Reporting System and are listed under the Food and Drug Administration Amendments Act of 2007, which requires the FDA to inform the public of new safety information or potential signals of serious risk, based on reviews of AERS.
But, the FDA cautioned, a drug’s appearance on the list doesn’t mean it definitely carries the risk only because the FDA has identified a potential safety issue.
“My message to patients is this: Don’t stop taking your medicine,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”