By Clifton Leaf and Sy Mukherjee
June 9, 2017

Greetings and happy Friday, readers. This is Sy.

There’s been a lot of renewed attention this month on the opioid overdose epidemic ravaging the nation. And for good reason—the Drug Enforcement Agency (DEA) released new guidelines warning that the synthetic opioid fentanyl is so deadly that first responders need to be extremely careful about the chance of an accidental overdose; a New York Times analysis found that that overdose deaths continued to rise in 2016 and that this year could be yet another record; a slew of overdoses in Georgia have been linked to a “mystery pill” containing fentanyl and other substances; and Ohio’s Attorney General is suing five drug makers over the epidemic.

On Thursday, the Food and Drug Administration (FDA) took one step meant to address the scourge by asking Endo International to withdraw its Opana ER long-lasting opioid from the U.S. market. Regulators had previously concluded that the treatment’s risks outweigh its benefits. “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,” said new FDA commissioner Dr. Scott Gottlieb in a statement.

The big question now is: What will Endo do? The company’s initial response suggested that it rejects the FDA’s implication of the drug’s dangers. “Despite the FDA’s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed,” said the company.

Endo shares tumbled 13% in Friday trading.

Read on for the day’s news, and enjoy your weekend.

Sy Mukherjee


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