Dr. Janet Woodcock on the Opioid Epidemic

The United States Food and Drug Administration (FDA) offers a podcast series, known as the Director’s Corner, that features the director of the FDA Center for Drug Evaluation and Research (CDER). One of the most recent episodes featured an interview with Dr. Janet Woodcock, by Colleen Labbe from the CDER Office of Communications, who discussed the way the FDA has been addressing the opioid epidemic affecting many communities around the United States. CDER’s Response to FDA Labeling Changes One of the first questions asked of Dr. Woodcock was what, exactly, CDER did with regard to the various opioid safety labeling changes that were announced in 2016. Dr. Woodcock noted that “part of our effort has been to change the labels – the actual instructions for use and warnings and so forth on opioid labels – to get more information to practitioners.” CDER has actually changed the product labels for hundreds of opioid products with numerous updates, including adding a boxed warning with safety information on all the immediate release opioid products. Dr. Woodcock said that the reason for the boxed warning on immediate release opioid products has to do “with their inherent risks – we strengthened the warnings about their risks.” CDER also added a warning about using benzodiazepines – also known as “benzos.” Benzos, as well as opioids, have respiratory depression characteristics, and in the event of an overdose, patients can increase their risk of very serious...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs