TURNING POINT

FDA Asks Drugmaker to Remove Opiate Painkiller From Shelves

A first in the country’s opioid epidemic.

The Food and Drug Administration has asked a pharmaceutical company to remove its opiate painkiller from the market over concerns people are abusing the drug. The regulator said Thursday that Endo Pharmaceuticals’ Opana ER painkiller poses more risks to patients than it does benefits, citing a “significant shift” from people crushing and snorting the drug to injecting it. “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 Scott Gottlieb said in a statement explaining the decision, the first of its kind in the opioid crisis. Gottlieb hinted that other drugmakers could soon see their medications pulled as well, saying the regulator will continue to take measures “when we see situations where an opioid product’s risks outweigh its benefits.” The drug was also blamed for an HIV and Hepatitis C outbreak in Indiana in 2015.