FDA Asks Pharmaceutical Co. to Pull Opioid Med From Stores

FDA Asks Pharmaceutical Co. to Pull Opioid Med From Stores

News Jun 12, 2017

June 10—The Food and Drug Administration (FDA) is asking Endo Pharmaceutical to voluntarily remove its opioid pain medication, Opana ER, from the market—a decision applauded by U.S. Sen. Joe Manchin, D-W.Va.

He said in a release this marks the first time the FDA has asked a pharmaceutical company to remove a drug because of the public health consequences of abuse.

Prior to the FDA's decision, Manchin privately urged Endo Pharmaceuticals to voluntarily remove Opana from the market after the joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee found that the risks of the drug outweighed the benefits.

He also raised the issue directly with Commissioner Dr. Scott Gottlieb prior to his confirmation as head of the FDA.

"I am pleased to see the FDA take this unprecedented step to fight the opioid epidemic," Manchin said. "The FDA serves a critical role as the agency that oversees the approval of these addictive drugs and I have advocated for years for the FDA seek the advice of its expert advisory panel and seriously follow its recommendations concerning the approval and reevaluation of dangerously addictive drugs for public use."

He said this is a critical step, but there is more work to be done in preventing opioid addiction and in ensuring every family impacted by the epidemic has access to quality treatment facilities.

"I have seen firsthand the devastating effects prescription drug abuse have had in West Virginia and states across our nation. I will continue to do all that I can to curb this epidemic."

___ (c)2017 The Register-Herald (Beckley, W.Va.) Visit The Register-Herald (Beckley, W.Va.) at www.register-herald.com Distributed by Tribune Content Agency, LLC.

Wendy Holdren
Fire inspections throughout the U.K. have discovered at least 7 other buildings with the same dangerous cladding found in Grenfell Tower, which caused a fire that claimed 79 lives.
Data shows a 64% increase in opioid-related visits from 2014.
The baby of the mother who went into premature labor will now receive free flights for life.
The legislation aims to treat addiction as a disease while another bill that would limit opiate pain medication prescriptions awaits approval from the Senate.
The state's House of Representatives has cut funding for initiatives aiming to reduce deaths from opioid overdoses.
The seminar discussed a number of addiction treatment resources people could utilize to help loved ones, employees or themselves.

A forest fire caused by high temperatures and a dry thunderstorm have killed dozens of people and left many others homeless.

First responders are not surprised carfentanil has made its way into the state and prepare for more overdoses.
When an 18-year-old died unexpectedly from cardiac arrest, his parents decided it was important to make AEDs available to the public to help save lives.
Thanks to immediate CPR from doctors riding alongside him, the otherwise healthy man survived what would have been a deadly heart attack.
Rep. Brad Wenstrup, podiatry surgeon and war veteran, came to the aid of Rep. Steve Scalise after he was shot by a gunman.
New York City's overdose deaths almost doubled between 2015 and 2016 due to the presence of fentanyl in opioids.
The gunman who shot Rep. Steve Scalise and three others died after being shot by police.
Six people suffered gunshot wounds, and four died, including the shooter, according to police.
Fire and rescue teams are struggling to reach victims of one of the most destructive landslides in the country's history.