FDA urged to add 'black box' warnings to sedative and painkiller packaging

By Matt Kuhrt

Overdose deaths from prescription painkillers have placed increased scrutiny on opioid prescribing practices, and now public health leaders have asked the U.S. Food and Drug Administration (FDA) to place a "black box" warning on packaging for both opioids and benzodiazepines, according to a post on the CommonHealth blog.

The combination of benzodiazepine sedatives and opioid painkillers is especially deadly, with traces of both drugs discovered in a third of unintentional overdose deaths in the United States during 2013, according to the CommonHealth report. Prominent warnings of this type can be helpful in changing doctors' prescribing habits, says Rhode Island Health Director Nicole Alexander-Scott.

Primary care physicians are increasingly likely to come into contact with patients in danger of opioid addiction, and a surprising number of doctors fail to ask patients about their history with prescription drugs, or even to mention the potential for addiction, according to recent reporting by FiercePracticeMangement.

The opioid epidemic has spurred the American Medical Association to urge changes in prescribing practices among physicians. The FDA's response so far has been focused on a "comprehensive action plan" that aims to reduce opioid abuse through further studies, a re-examination of risks and benefits of new painkillers, and the addition of safety information to labeling for immediate-release painkillers, according to a USA Today story. The agency has also convened advisory committees prior to the approval of opioids not specifically designed to deter their abuse, the article noted.

In the USA Today report, Senator Edward Markey (D-Mass.) blasted the agency's response as insufficient, accusing the FDA of acting as "a rubber stamp approving the latest Big Pharma painkillers." For her part, Alexander-Scott voiced cautious optimism, saying she's had "encouraging talks" with the agency, and has hopes that it will agree to the warnings.

To learn more:
- read the CommonHealth post
- read the USA Today article