New Warnings for Opioids

Immediate-release opioid pain medications get new warnings, rules from FDA

/ Author:  / Reviewed by: Beth Bolt, RPh

(RxWiki News) To help stem the tide of opioid abuse, misuse and deaths, the US Food and Drug Administration (FDA) has updated its warnings about these pain-killing prescription drugs.

Chief among those updated rules is a requirement that immediate-release opioids must be labeled with a boxed warning that notes the serious risk of abuse, addiction and overdose tied to these drugs, which include morphine (brand name Avinza), oxycodone (Oxycontin) and hydrocodone (Vicodin).

Part of that boxed warning must also include a warning that opioid use during pregnancy can lead to neonatal opioid withdrawal syndrome, a potentially life-threatening condition in which a newborn experiences withdrawal symptoms much like someone addicted to opioids might when trying to quit.

Other FDA-mandated changes to the labeling of opioid drugs included required safety information about several potential drug interactions and adverse effects.

The bulk of these new warnings and changes applies to immediate-release opioids, but the FDA, as part of its ongoing effort to reduce public health harm tied to these drugs, has issued similar warnings about long-acting opioids in the past.

The FDA issued several other warnings about these medications. Talk to a doctor or pharmacist about the potential risks tied to pain medications.

Reviewed by: 
Review Date: 
March 27, 2016
Last Updated:
March 28, 2016