Black Box for Opiates: New Warning Labels in Face of Addiction Epidemic

March 24, 2016

On Tuesday, the Food and Drug Administration announced that all opiate medications will be required to carry the agency’s most stringent warning, the “black box,” in hopes of deterring doctors from prescribing the drugs in inappropriate cases. The “black box” warning is reserved for cases with experimental evidence of serious or life-threatening adverse events associated with a drug. The addition of this warning is the latest effort by the federal government to combat the rising tide of opiate-related deaths in the United States, with the aim of stopping opiate addiction where it often begins - with prescription pills. 

Other federal efforts to address the increasing number of overdose deaths are in process but have largely stalled on Capitol Hill. Local governments in some cities have looked to creating safe injection centers as a means to at least lower the amount of death and disease associated with these addictions, and CVS has made the “overdose reversal” drug Narcan (naloxone) available without a prescription in many states, including Pennsylvania. Prevention Point Philadelphia, an outreach organization many Jefferson students may be familiar with, currently offers Narcan and Narcan training as a component of its harm-reduction approach to treatment of substance abuse.

Article: http://www.npr.org/sections/health-shots/2016/03/22/471446330/fda-requires-strong-new-safety-warnings-for-opioids