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A couple of in 5 folks prescribed extended-release painkillers equivalent to OxyContin developed an dependancy inside a yr, in keeping with a newly launched research mandated by the U.S. Meals and Drug Administration.
The research, repeatedly delayed by greater than a decade and launched on Might fifth, revealed a far larger share of ache sufferers hooked on opioids than drugmakers’ gross sales reps claimed of their advertising and marketing supplies and representations to physicians.
The FDA now faces the query of how one can use this information to guage whether or not the company ought to make adjustments to opioid regulation, limiting broad approvals of long-acting opioids for prolonged use. The FDA is at the moment holding hearings to debate the findings and is being requested by advocates to vary the medicine’ labels, which information how docs prescribe them.
When the opioid market was thrown open to tens of millions of power ache sufferers within the Nineties and early 2000s, Purdue Pharma’s gross sales reps and promotional movies asserted that fewer than 1% of sufferers grew to become hooked on painkillers. Prolonged-release capsules had been designed to repeatedly dose opioids to stave off power ache.
Knowledge launched present that 22.5% of ache sufferers who began on extended-release, long-acting medicine developed opioid use dysfunction, or dependancy, inside a yr. The findings stem from a post-marketing research requirement mandated by the FDA in 2013.
“The findings are striking and disturbing and they raise ethical questions because so many study subjects were harmed,” mentioned Andrew Kolodny, president of Physicians for Accountable Opioid Prescribing. “How can you have a label that suggests this is safe and effective when you now have evidence that it’s unsafe and still don’t have evidence that it’s effective?”
In March, Purdue filed a $7.4 billion chapter plan to resolve hundreds of lawsuits associated to the corporate’s position within the opioid epidemic. A consultant for Purdue declined to remark. Spokespeople for Mallinckrodt and Endo weren’t instantly accessible.
Efforts to get a transparent image of precisely how addictive these long-acting opioids are have been thwarted by the years as drugmakers and affected person advocates lobbied for simple entry to opioids and disputed the definition of “addiction.” The epidemic has claimed greater than 800,000 lives within the US since 1999 and stays a significant public well being downside.
Tens of millions of Individuals have grow to be depending on opioid capsules, at the same time as mounting proof suggests these medicine ought to by no means have been authorized as protected and efficient for power ache.
The company’s personal labeling—meant to outline a drug’s use, flag its dangers, and restrict its advertising and marketing—helped legitimize widespread, high-dose, long-term prescribing with out the medical proof to assist it, as revealed in a Businessweek investigation.
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Practically quarter of individuals on long-acting opioids develop dependancy, research reveals (2025, Might 6)
retrieved 6 Might 2025
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