FDA Week - 04/12/2019

FDA Requires Opioid Labeling Include Dose Tapering Information

April 10, 2019
FDA is requiring changes to the prescribing information for all opioid analgesic medicines used in the outpatient setting to provide more information about how health care providers can safely decrease the dose in patients who are physically dependent on opioids, the agency announced Tuesday (April 9). The agency also said it soon will follow through on plans to require immediate-release opioids be made available in fixed-quantity packaging. FDA has received reports of serious withdrawal symptoms, uncontrolled pain and suicide in...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on the coming Democrat-controlled House of Representatives, drug pricing reforms, Medicaid policy, FDA news and much more.