FDA moves to pull Endo’s opi­oid pain med­i­ca­tion off the mar­ket

Modern Healthcare - - LATE NEWS - —Alex Kacik

Cit­ing pub­lic safety con­cerns, the U.S. Food and Drug Ad­min­is­tra­tion late last week took the rare step of aim­ing to re­move an opi­oid pain med­i­ca­tion from the mar­ket.

The agency re­quested that Endo Phar­ma­ceu­ti­cals pull Opana ER, say- ing that risks as­so­ci­ated with the med­i­ca­tion out­weigh the ben­e­fits.

It’s one of the first times that the FDA has tried to get an opi­oid pain med­i­ca­tion off the mar­ket be­cause of the pub­lic health con­se­quences of abuse.

“We are fac­ing an opi­oid epi­demic—a pub­lic health cri­sis, and we must take all nec­es­sary steps to re­duce the scope of opi­oid mis­use and abuse,” FDA Com­mis­sioner Dr. Scott Got­tlieb said. “We will con­tinue to take reg­u­la­tory steps when we see sit­u­a­tions where an opi­oid prod­uct’s risks out­weigh its ben­e­fits.”

Opana ER was re­for­mu­lated in 2012 to make it harder to crush, ide­ally re­duc­ing abuse through snort­ing the painkiller. In­stead many users dis­solved and in­jected the drug, which has led to out­breaks of HIV and hep­ati­tis C, ac­cord­ing to the FDA.

The agency said it would take for­mal ac­tion to re­move the prod­uct from mar­ket if Endo Phar­ma­ceu­ti­cals de­nies the FDA’s re­quest. In the mean­time, the FDA is mak­ing health­care pro­fes­sion­als aware of risks as­so­ci­ated with the painkiller. The agency will con­tinue to re­view the risks and ben­e­fits of sim­i­lar drugs.

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