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FDA takes fresh look at whether opioids are effective for chronic pain
Source: Washington Post
FDA takes fresh look at whether opioids are effective for chronic pain
By Lenny Bernstein and Laurie McGinley February 25 at 4:19 PM
The Food and Drug Administration will require drug companies to study whether prescription opioids are effective in quelling chronic pain — another step in the government’s efforts to rein in use of the narcotics that spawned the drug epidemic.
Some studies already indicate that opioids are ineffective for pain beyond 12 weeks and many experts say long-term use can cause addiction, by prompting patients to build up tolerance to the drugs and seek higher doses. But conclusive, controlled research is scarce.
A finding of ineffectiveness in more rigorous studies supervised by the FDA could allow the agency to change the labeling on some opioids, impose special rules for prescribing, dispensing and taking them, and even prohibit their use in some cases, according to FDA Commissioner Scott Gottlieb.
“We are going to impose a mandate on existing products .?.?. to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction,” Gottlieb said in an interview.
But at least one longtime critic of the FDA’s response to the opioid crisis expressed frustration with the move. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, said the FDA already has all the research it needs — and authority under existing law — to tighten restrictions on the use of opioids for chronic pain by changing instructions for how they should be prescribed.
-snip-
By Lenny Bernstein and Laurie McGinley February 25 at 4:19 PM
The Food and Drug Administration will require drug companies to study whether prescription opioids are effective in quelling chronic pain — another step in the government’s efforts to rein in use of the narcotics that spawned the drug epidemic.
Some studies already indicate that opioids are ineffective for pain beyond 12 weeks and many experts say long-term use can cause addiction, by prompting patients to build up tolerance to the drugs and seek higher doses. But conclusive, controlled research is scarce.
A finding of ineffectiveness in more rigorous studies supervised by the FDA could allow the agency to change the labeling on some opioids, impose special rules for prescribing, dispensing and taking them, and even prohibit their use in some cases, according to FDA Commissioner Scott Gottlieb.
“We are going to impose a mandate on existing products .?.?. to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction,” Gottlieb said in an interview.
But at least one longtime critic of the FDA’s response to the opioid crisis expressed frustration with the move. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, said the FDA already has all the research it needs — and authority under existing law — to tighten restrictions on the use of opioids for chronic pain by changing instructions for how they should be prescribed.
-snip-
Read more: https://www.washingtonpost.com/national/health-science/fda-takes-fresh-look-at-whether-opioids-are-effective-for-chronic-pain/2019/02/25/227a5fe6-3917-11e9-a06c-3ec8ed509d15_story.html
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