FDA Wants Painkiller Popular With Those Addicted To Opioids Removed From Market

The New York Times: F.D.A. Asks Drug Maker To Stop Selling A Dangerous Opioid
On Thursday, for the first time in its history, the Food and Drug Administration asked a drug company to take an opioid medication off the market. The drug, Opana ER — a form of the painkiller oxymorphone hydrochloride — has been heavily abused and linked to outbreaks of H.I.V., hepatitis C and a serious blood disorder among people who crush the pills into powder and inject it. (Grady, 6/8)

The Washington Post: FDA Seeks Removal Of Opioid Painkiller From The Market
The agency concluded after an extensive review of Endo Pharmaceuticals’ Opana ER that the “benefits of the drug may no longer outweigh its risks.” The company reformulated the drug in 2012 to make it more difficult to snort, but the FDA said that move actually led to more injections — and a major HIV outbreak. (McGinley and Bernstein, 6/8)

The Wall Street Journal: FDA Pushes To Get Endo’s Opana ER Painkiller Off The Market
“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. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.” (Whalen, 6/8)

USA Today: FDA Asks Drugmaker Endo To Withdraw Opana ER
The FDA said in its statement that if Endo does not meet its request, it will take steps to withdraw approval of the drug, prescribed when someone needs a long-term pain medication. Endo reformulated Opana ER in a way that the company said would curb the potential for abuse, but an FDA advisory committee voted 18-8 (with one abstention) in mid March that the benefits of the reformulated version no longer outweigh risks of the drug. (Eversley, 6/8)

NPR: FDA Wants Opana ER, A Powerful Opioid, Off The Market
An increasing number of people, the FDA says, are abusing the powerful prescription pills by crushing, dissolving and injecting them. The sharing of needles by these drug users has fueled an outbreak of associated infectious diseases — HIV, hepatitis C and another serious blood disorder. (Stein, 6/8)

Stat: FDA Wants To Yank An Opioid Painkiller Over Concerns About Abuse
It is unclear, however, whether Endo will comply. In a statement, the drug maker indicated it is “reviewing the request and is evaluating the full range of potential options.” In fact, the company appears ready for a fight. We say that because Endo argued that the FDA request “does not indicate uncertainty” that Opana ER is safe or effective when taken as prescribed. “Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.” (Silverman, 6/8)

Bloomberg: FDA Seeks To Pull Pain Pill Off Market, Citing Risk Of Abuse 
The move marks a shift in FDA policy, pushed by Commissioner Scott Gottlieb, to consider how opioids are used not just by appropriate patients but also by drug abusers. Thousands of Americans die each year from opioid overdoses, as do many more who switch from the pills to heroin. (Edney and Langreth, 6/8)

In other news on the crisis —

The Wall Street Journal: Drug Gangs Open An Online Chinese Connection For Opioids
New York City gang members are increasingly bypassing their usual sources for drugs and buying powerful illicit opioids directly from China online, according to investigators, who say the trend poses tough new challenges for law enforcement trying to crack down on the addiction epidemic. The latest clue came in a package seized after a search warrant was executed in November, investigators say. It contained a kilogram of the opioid drug furanyl fentanyl—and the name of an obscure Chinese company called Shenzhen Unique-Peptide Biotechnology Co. Ltd. (Kanno-Youngs and Whalen, 6/8)

The Washington Post: Opioids, Alcohol, Other Drugs Killed More Marylanders In 2016 Than Ever Before
The increase in drug- and alcohol-related deaths in Maryland in 2016 was the biggest ever recorded in the state, officials said Thursday, the latest sign of an opioid epidemic that has triggered a state of emergency and prompted leaders to dedicate millions in funding to combat addiction. Overdoses killed 2,089 people in 2016, an increase of 66 percent from the previous year, according to data released by the Maryland Department of Health and Mental Hygiene. (Hernandez, 6/8)

The Baltimore Sun: Deaths From Drug, Alcohol Overdoses Skyrocket In Maryland 
The number of people who died in Maryland from drug and alcohol related overdoses surged 66 percent in 2016, compared with 2015, exposing the magnitude of the growing opioid epidemic and the ineffectiveness of the increased resources aimed a stemming deaths. The 2,089 deaths last year represent an all-time high, triple the tally from 2010, according to the data released Thursday by the state Department of Health and Mental Hygiene. Last year's jump is the state's largest recorded annual increase. (Cohn, 6/8)

Columbus Dispatch: "It's Absolutely Everywhere" DeWine Tells DC Panel On Opioids
As lawmakers pondered the economic costs of an opioid epidemic that is devastating Ohio, state Attorney General Mike DeWine offered a set of grim circumstances that seemed to stun them into silence. Babies born drug dependent, confined to neonatal intensive care units for an average of 14 days at tremendous cost to the state’s health care system. (Wehrman, 6/8)