FDA issues draft guidance on drug dependence, usage labeling

The Food and Drug Administration yesterday released new draft guidance for labeling medications that carry the risk of abuse or dependence, including but not limited to opioids, and simplifying labels with complicated usage instructions. Changes for potentially habit-forming drugs include defining terminology, such as abuse, misuse, addiction, physical dependence and tolerance, to avoid misinterpretation on labels. According to the guidance, opioid-specific labeling should include information about how health care professionals can safely decrease the dosage in physically dependent patients, with a goal of finding the balance in pain management and reduced use. For medications with detailed instructions for use, the FDA recommends patient-friendly visual guides that are consistent in content and format.