Panel calls on FDA to review safety of opioid painkillers

Associated Press

The U.S. Food and Drug Administration should review the safety and effectiveness of all opioids, and consider the real-world impacts the powerful painkillers have, not only on patients, but also on families, crime and the demand for heroin.

That’s the conclusion of a sweeping report Thursday from the National Academies of Sciences, Engineering and Medicine. It urges the FDA to bolster a public-health approach that already has resulted in one painkiller being pulled from the market. Last week, the maker of opioid painkiller Opana ER withdrew its drug at the FDA’s request following a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles to inject the pills.

“Our recommendation is for a much more systematic approach, integrating public-health decision-making into all aspects of opioid review and approval,” said Dr. Aaron Kesselheim of Harvard Medical School, a member of the report committee. “It would be an ambitious undertaking.”

The report details how two intertwining epidemics – prescription painkillers and heroin – led to the worst addiction crisis in U.S. history and provides a plan for turning back the tide of overdose deaths.

Prescribed, legal drugs are a gateway to illicit drugs for some, the report says. Other users start with pills diverted to the black market. Crush-resistant pills and other restrictions can have unintended consequences, shifting use to heroin and illicit fentanyl.

The epidemic’s broad reach into rural and suburban America “has blurred the formerly distinct social boundary between use of prescribed opioids and use of heroin and other illegally manufactured ones,” the report says.