Food and Drug Administration (FDA) is requiring that all labels for opioid pain analgesics clarify the risks associated with long-term use. The updated labels will include the following:
- dosing warnings;
- summary of study results detailing the estimated risks of addiction, misuse, and overdose when using medications long term;
- treatment guidance;
- reminders of safe discontinuation;
- information on overdose reversal agents;
- warning of drug interactions;
- risks of toxic leukoencephalopathy; and
- information related to opioid effects on the esophagus.
Additionally, the phrase “extended treatment period” will be removed to avoid the misinterpretation that taking opioids over an indefinite period is safe. More information is available on the FDA website.