The Food and Drug Administration announced Tuesday it will require immediate-release opioid painkillers to carry a “black box” warning about the risk of misuse, abuse, addiction, overdose and death, CNN reports.
The new head of the Food and Drug Administration, Dr. Robert Califf, told a panel of advisers this week that the agency will support the development of abuse-deterrent opioids, the Associated Press reports.
Officials from state and local health departments around the country are urging the Food and Drug Administration to add “black box” warnings to opioid painkillers and sedatives known as benzodiazepines, to alert people that taking them together increases the risk of fatal overdoses.
The U.S. Food and Drug Administration has announced it will reassess its approach to opioid medications, in an effort to reverse the epidemic of abuse. The plan comes in response to pressure from Congress, The New York Times reports.
The U.S. Food and Drug Administration (FDA) declined to approve a new drug application for a second nasal spray version of the opioid overdose antidote naloxone, Medscape reports. The FDA approved a nasal spray version of naloxone last month.
The Food and Drug Administration on Tuesday ordered tobacco company R.J. Reynolds to stop selling four cigarette products. It is the first time the agency has ordered a major tobacco company to stop selling products, according to NPR.