FDA Advisers Vote Against Approving New Opioid Painkiller
10 years, 11 months ago

FDA Advisers Vote Against Approving New Opioid Painkiller

NPR  

FDA Advisers Vote Against Approving New Opioid Painkiller Enlarge this image iStockphoto iStockphoto A key government panel Tuesday voted unanimously against approval of a powerful opioid prescription painkiller intended to provide faster relief with fewer side effects. The committee also voted unanimously that the drug's developer had not proved that Moxduo is less likely to cause potentially life-threatening respiratory suppression than taking morphine or oxycodone alone. The FDA's experts disagreed on whether the company's studies show that the drug delivers the intended benefits, which supposedly include better pain relief, fewer side effects or lower risk of life-threatening complications. Addiction researchers also argued that the drug raises concerns that it could be more easily abused than opioid drugs like Vicodin and Percocet, which could make the nation's epidemic of prescription painkiller abuse even worse.

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History of this topic

FDA approves new painkiller that shows promise and challenges of opioid alternatives
1 month, 3 weeks ago

FDA approves new painkiller that shows promise and challenges of opioid alternatives

Live Mint  

WASHINGTON — Federal officials on Thursday approved a new type of pain drug designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin. Two studies in more than 870 patients with acute pain following foot and abdominal surgeries showed Vertex’s drug provided more relief than a dummy pill but didn’t outperform a common …

FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
1 month, 3 weeks ago

FDA approves painkiller designed to eliminate the risk of addiction associated with opioids

Associated Press  

WASHINGTON — Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin. Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex’s drug provided more relief than a dummy pill but didn’t outperform a common …

FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
1 month, 3 weeks ago

FDA approves painkiller designed to eliminate the risk of addiction associated with opioids

LA Times  

The Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often follows surgery or injuries. Studies in more than 870 patients with acute pain from foot and abdominal surgeries showed Vertex’s drug provided more relief than a dummy pill but didn’t outperform a common opioid-acetaminophen combination pill. “The new medication has side effect profiles that …

FDA panel weighs moving opioid antidote over the counter
2 years, 1 month ago

FDA panel weighs moving opioid antidote over the counter

The Independent  

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FDA chief says long-awaited opioid review still in the works
2 years, 6 months ago

FDA chief says long-awaited opioid review still in the works

Associated Press  

WASHINGTON — A long-awaited review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway at the Food and Drug Administration, the agency’s commissioner said Tuesday. Dr. Robert Califf wrote in a blog entry that the FDA is still studying “what revisions are needed to support appropriate use” of opioid painkillers and “lessons …

FDA chief’s long-promised opioid review faces skepticism
2 years, 7 months ago

FDA chief’s long-promised opioid review faces skepticism

Associated Press  

WASHINGTON — As U.S. opioid deaths mounted in 2016, the incoming head of the Food and Drug Administration promised a “sweeping review” of prescription painkillers in hopes of reversing the worst overdose epidemic in American history. “It seems like people love sort of looking back and fault-finding, but I’m much more interested in learning so we can go forward and …

FDA chief's long-promised opioid review faces skepticism
2 years, 7 months ago

FDA chief's long-promised opioid review faces skepticism

The Independent  

For free real time breaking news alerts sent straight to your inbox sign up to our breaking news emails Sign up to our free breaking news emails Sign up to our free breaking news emails SIGN UP I would like to be emailed about offers, events and updates from The Independent. In an interview with The Associated Press, Califf said …

CDC proposes softer guidance on opioid prescriptions
3 years, 1 month ago

CDC proposes softer guidance on opioid prescriptions

Associated Press  

NEW YORK — The nation’s top public health agency on Thursday proposed changing — and in some instances, softening — guidelines for U.S. doctors prescribing oxycodone and other opioid painkillers. But it also caused some doctors to become too quick to cut off patients taking prescription painkillers and too strict in keeping the drugs from patients who might benefit, CDC …

Revamped OxyContin was supposed to reduce abuse, but has it?
5 years, 8 months ago

Revamped OxyContin was supposed to reduce abuse, but has it?

Associated Press  

WASHINGTON — Dr. Raeford Brown was uniquely positioned to help the U.S. government answer a critical question: Is a new version of the painkiller OxyContin helping fight the national opioid epidemic? Nearly a decade ago, the FDA approved reformulated OxyContin and told the company, Purdue Pharma, that it would be evaluated on whether the new version decreased cases of addiction, …

Despite Warnings, FDA Approves Potent New Opioid Painkiller
6 years, 4 months ago

Despite Warnings, FDA Approves Potent New Opioid Painkiller

NPR  

Despite Warnings, FDA Approves Potent New Opioid Painkiller Enlarge this image toggle caption Chip Somodevilla/Getty Images Chip Somodevilla/Getty Images The Food and Drug Administration has approved a potent new opioid painkiller, despite warnings from physician critics who say the drug will contribute to the addiction epidemic. Though the advisory committee ultimately voted in favor of the drug, Public Citizen contends …

FDA Panel Affirms Safety Of Painkiller Celebrex
6 years, 11 months ago

FDA Panel Affirms Safety Of Painkiller Celebrex

NPR  

FDA Panel Affirms Safety Of Painkiller Celebrex Enlarge this image toggle caption Daniel Acker/Bloomberg via Getty Images Daniel Acker/Bloomberg via Getty Images Updated at 1:54 p.m. A prescription painkiller that has been under a cloud for more than a decade is apparently safer than previously believed, a Food and Drug Administration panel concluded Wednesday. The drug celecoxib, which is sold …

Doctors In Maine Say Halt In OxyContin Marketing Comes '20 Years Late'
7 years, 1 month ago

Doctors In Maine Say Halt In OxyContin Marketing Comes '20 Years Late'

NPR  

Doctors In Maine Say Halt In OxyContin Marketing Comes '20 Years Late' Enlarge this image toggle caption George Frey/Bloomberg via Getty Images George Frey/Bloomberg via Getty Images The maker of OxyContin, one of the most prescribed and aggressively marketed opioid painkillers, will no longer tout the drug or any other opioids to doctors. The announcement, made Saturday, came as drugmaker …

A guide to prescribing painkillers ethically
7 years, 6 months ago

A guide to prescribing painkillers ethically

Daily Mail  

America's opioid crisis is getting worse. As a bioethicist working on the ethical and policy issues regarding prescription opioids, I am grateful to the National Academy of Medicine for inviting me to serve on this publication's authorship team, and for taking seriously the ethical component of the prescription opioid crisis. A National Academy of Medicine researcher has written a guide …

Powerful Narcotic Painkiller Up For FDA Approval
10 years, 11 months ago

Powerful Narcotic Painkiller Up For FDA Approval

NPR  

Powerful Narcotic Painkiller Up For FDA Approval toggle caption Rich Pedroncelli/AP The Food and Drug Administration is trying to decide whether to approve a powerful new prescription painkiller that's designed to relieve severe pain quickly, and with fewer side effects than other opioids. It's designed to provide quick relief to patients suffering severe pain from accidents or surgeries, such as …

FDA Ratchets Down On Prescribing Of OxyContin And Other Opioids
11 years, 6 months ago

FDA Ratchets Down On Prescribing Of OxyContin And Other Opioids

NPR  

FDA Ratchets Down On Prescribing Of OxyContin And Other Opioids toggle caption Toby Talbot/Associated Press The Food and Drug Administration today took another step toward restricting use of OxyContin and other powerful and often-abused prescription pain medications. "The FDA is invoking its authority to require safety labeling changes and post-market studies to combat the crisis of misuse, abuse, addiction, overdose …

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