Enlarge / FDA Commissioner Scott Gottlieb has made it clear he intends to crack down on opioid drugs. (credit: Getty | Zach Gibson)
The Food and Drug Administration requested Thursday that Endo Pharmaceuticals yank its powerful opioid drug, Opana ER (oxymorphone hydrochloride), from the market due to the “public health consequences of abuse.” If Endo fails to voluntarily comply, the FDA will force its hand, the agency stated in an announcement.
The move may mark the start of an industry-wide crackdown on opioid pain killers—spearheaded by the agency’s new Commissioner Scott Gottlieb, who has made clear that addressing the opioid epidemic is a priority. Last month, he urged staff at the agency to take “more forceful steps” to try to curb the devastating outbreak of abuse and addiction.

The Centers for Disease Control and Prevention estimates that about 91 Americans die each day from opioid overdoses.The drugs killed more than 33,000 in 2015.
Opana ER, a reformulated extended-release opioid marketed for long-term use, has been heavily abused and linked to the outbreak of infectious diseases, the FDA noted.

The drug is designed to stretch for 12 hours.

But people suffering with addictions often crush and inject the drug, which provides an intense high all at once.

This has contributed to needle-sharing among opioid users, spurring the spread of infectious diseases including HIV and Hepatitis C. Opana was at the center of an HIV outbreak in Indiana in 2015, for instance.
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