FDA Reveals New Opioid Labeling

The FDA has unveiled enhanced warnings for opioid pain medications that will affect 141 generic and 87 innovative immediate-release opioid products, which account for roughly 90 percent of all prescription opioids.

The new boxed warning covers the risks of misuse, abuse, addiction, overdose and death. Labeling was updated due to the increasing number of reports of abuse and misuse, agency officials told reporters during a conference call last week.

The updated information clarifies that because of these risks, IR opioids should be reserved only for patients suffering severe pain for whom there are no other treatment options, the FDA says.

Dosing information also will be clearer, providing instructions on the initial dosage, dosage changes during therapy and a warning to refrain from abruptly stopping treatment in a physically dependent patient.