The U.S. Food and Drug Administration has updated labels for nearly 400 opioids and benzodiazepines following a review of scientific evidence and a citizen petition from health officials across the nation arguing that combining the drug classes increases the risk of addiction and death. The makers of around 400 prescription opioid analgesics, cough medications with opioids and tranquilizers called benzodiazepines will have to add the agency’s strongest form of warning, a black box, to the drugs, stating the risks of using them together. Those risks include sleepiness, respiratory depression, coma and death. The FDA is also requiring patient guides to better help patients understand the risks of mixing the two classes of drugs. Major benzodiazepines include: Xanax, Klonopin, Ativan and Halcion, and major opioid painkillers include Vicodin, Oxycontin, Opana, Percocet, Demerol and morphine. The cough medicines include the drugs hydrocodone and codeine.
According to the petition, some opioids currently have labels with warnings to not mix the drugs with benzodiazepines, but no opioids have the more severe black box warning. The petition was signed by the heads or medical directors of the health departments in Alaska, Arizona, Arkansas, Connecticut, Delaware, Maryland, Massachusetts, Minnesota, Montana, Pennsylvania, Rhode Island, South Carolina, Vermont and West Virginia; Guam and the Northern Mariana Islands; and Baltimore, Boston, Chicago, Dallas, Denver, Detroit, Houston, Minneapolis, New York, Philadelphia, and Sacramento, San Francisco and Long Beach, California.
This was reported by Law 360 on August 31, 2016.
Contact Information: Sandy Walsh, Press Officer, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993; 301-796-4669; Email: firstname.lastname@example.org; Website: www.fda.gov