Panel calls on FDA to re­view safety of opi­oid painkillers

Kuwait Times - - HEALTH & SCIENCE -

The US 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 de­ci­sion­mak­ing 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 US 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. The au­thors say it’s pos­si­ble to stem the cri­sis with­out deny­ing opi­oids to pa­tients whose doc­tors pre­scribe them re­spon­si­bly. But long-term use of opi­oids by peo­ple with chronic pain should be dis­cour­aged be­cause it in­creases dan­gers of over­dose and ad­dic­tion. Re­quested by the FDA last year un­der the Obama ad­min­is­tra­tion, the re­port was greeted by FDA Com­mis­sioner Dr Scott Got­tlieb, a Trump ap­pointee. Got­tlieb said in a state­ment that the opi­oid epi­demic is his “high­est im­me­di­ate pri­or­ity” and he “was en­cour­aged to see that many of (the) rec­om­men­da­tions for the FDA are in ar­eas where we’ve al­ready made new com­mit­ments.”

Still, no im­me­di­ate re­view of opi­oids as a class of drugs is planned by the FDA, other than the agency’s rou­tine safety sur­veil­lance. Got­tlieb said the FDA re-eval­u­ates the safety of ap­proved drugs with post-mar­ket in­for­ma­tion re­quired from drug­mak­ers and other sources. “We will con­tinue to con­sider what ad­di­tional in­for­ma­tion is needed to en­sure we have the right data to make im­por­tant, sci­ence-based de­ci­sions,” he said.

Be­yond the FDA, the re­port rec­om­mends:

1- Bet­ter ac­cess to treat­ment for opi­oid ad­dic­tion, in­clud­ing use of med­i­ca­tions such as buprenor­phine, in set­tings in­clud­ing hos­pi­tals, pris­ons and treat­ment pro­grams. (The re­vised Se­nate Repub­li­can health care bill re­leased Thurs­day in­cludes $45 bil­lion for states to use for ad­dic­tion treat­ment and other re­sponses to the opi­oid cri­sis, a boost over the $2 bil­lion in the ini­tial bill.)

2- Year-round pro­grams that al­low peo­ple to re­turn un­used opi­oids to any phar­macy at any time, rather than only at oc­ca­sional events. Some phar­ma­cies, in­clud­ing Wal­greens, have in­stalled kiosks where peo­ple can get rid of pills.

3- In­sur­ers pay for pain con­trol that goes be­yond opi­oids to in­clude non-drug treat­ment. The re­port doesn’t spec­ify which treat­ments in­sur­ers should cover, but does out­line what early ev­i­dence ex­ists for acupunc­ture, phys­i­cal ther­apy, cog­ni­tive-be­hav­ioral ther­apy and mind­ful­ness med­i­ta­tion, call­ing them “pow­er­ful tools.”

4- More re­search on the na­ture of pain and dependency on opi­oids and de­vel­op­ment of new non­ad­dic­tive treat­ments.—AP

MONTPELIER, Ver­mont: This file photo shows hy­drocodone-ac­etaminophen pills, also known as Vi­codin, ar­ranged for a photo at a phar­macy in Montpelier, Ver­mont.—AP

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