The U.S. Food and Drug Administration (FDA) announced on July 31, 2025, that manufacturers of opioid painkillers will be required to update prescribing information to more clearly highlight the risks of long-term use. This decision is based on two recently completed observational studies that examined risks such as misuse, addiction, overdose, and fatal and non-fatal consequences with long-term use. The new information is intended to help physicians and patients make informed decisions about benefits and risks.
The FDA recommends that physicians consider the cause and impact on patients' quality of life when assessing pain. If opioid therapy is necessary, the lowest effective dose of an immediate-release opioid should be prescribed for the shortest duration necessary. Extended-release opioids are reserved for severe, persistent pain when alternatives are lacking. Patients should be informed about opioid overdose reversal medications such as naloxone. Regular reassessments of the benefit-risk profile and avoidance of abrupt dose reductions are recommended to prevent withdrawal symptoms or uncontrolled pain.
Patients are urged to take opioids exactly as prescribed, store them securely, and dispose of unused medications properly. Medical attention should be sought immediately for symptoms such as breathing problems. Side effects can be reported through the FDA's MedWatch program.
As of: 08/04/2025
