The US FDA has issued new class-wide safety labeling changes for immediate-release (IR) opioid pain medications, which make up about 90% of all opioid prescriptions.
The new labels include a new boxed warning about the risks for misuse, abuse, addiction, overdose and death.
The FDA said today IR opioid products are indicated not for merely moderate pain but rather only for the management of pain severe enough to require opioid treatment and for which alternative treatments are inadequate.
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