Required Black Box Warnings on Immediate Release Opioids

Closely following on recent efforts undertaken by states and the Centers for Disease Control to curb opioid abuse (review further here and here), the U.S. Food and Drug Administration (FDA) last week announced that it will require black box warnings on immediate-release opioids highlighting the risk of “misuse, abuse, addiction, overdose and death,” to combat what the agency described as an epidemic of addiction. 

Ninety percent of opioids prescribed are immediate-release, which are usually taken every four to six hours. The remaining ten percent, extended-release/long-acting (ER/LA) opioids, are typically viewed as more prone to abuse because they include more opioid per tablet. The FDA added a black box warning for ER/LA opioids in 2013.

The new FDA black box requirements will apply to drugs such as hydrocodone, oxycodone and other frequently prescribed immediate release painkillers. The labels will include a variety of warnings about the risk of addiction, misuse, overdose and death. There are a number of required warnings regarding interactions with other medications and the effect of opioids on patients with certain conditions.  

The FDA stated said that the labels will likely be approved and finalized by the end of the year and that no recall will be necessary. The new labels will affect 87 brand-name drugs and 141 generics—ranging from acetaminophen-opioid combinations to intravenous therapy formulations.

Draft Guidance Promoting Generic Abuse-Deterrent Opioids

The FDA also issued draft guidance which it noted is intended to support the manufacturing industry in the development of generic versions of opioids with abuse-deterrent formulations (ADF). Abuse deterrent mechanisms make certain types of abuse—such as crushing or dissolving tables so as to snort or inject the contents—less effective. The FDA seeks comments from stakeholders on the draft guidance, due June 25, 2016.

The FDA had already required all sponsors of brand name products with approved abuse-deterrent labeling to conduct long-term epidemiological studies to assess their effectiveness in reducing abuse. 

The FDA has noted that it plans to hold public meetings related to opioid abuse issues.