Updated OxyContin hasn’t curbed overdoses & abuse
WASHINGTON, Sept 12, (AP): A panel of government health advisers said Friday there’s no clear evidence that a harder-to-crush version of the painkiller OxyContin designed to discourage abuse actually resulted in fewer overdoses or deaths.
The conclusion from the Food and Drug Administration advisory panel comes more than a decade after Purdue Pharma revamped its blockbuster opioid, which has long been blamed for sparking a surge in painkiller abuse beginning in the 1990s.
In a series of non-binding votes, the FDA experts said that the updated OxyContin appeared to cut down abuse via snorting and injecting, compared to the original drug. But panelists overwhelmingly ruled that data from Purdue and other researchers did not show that the reformulation curbed abuse overall or led to fewer overdoses.
Panelists said the shortcomings were due, in part, to the challenges of studying overdoses, which often involve multiple drugs.
“I think it’s very difficult to tease out cause of death and overdose,” said Dr. Lewis Nelson of Rutgers University. “Overall, I think the quality of evidence was fairly poor.”
The long-acting OxyContin tablets can still be misused by simply swallowing them, which remains the most frequent route among those with opioid addiction.
The FDA will consider the group’s opinions as it weighs whether to revisit OxyContin’s terms of approval. That could include scaling back the drug’s prescribing labeling, which currently states that it is “expected to” reduce abuse via injecting and snorting.
Purdue’s 2010 revamped OxyContin was the first of several opioids developed by drugmakers to help curb abuse. But whether the drugs met that goal remains unclear and the FDA is reviewing their use.
Opioid
These so-called abuse-deterrent formulations account for just 2% of US opioid prescriptions. The vast majority of opioids prescribed are generic versions of short-acting opioids like hydrocodone.
Purdue representatives said during the meeting that multiple studies showed the updated tablets are harder to crush and dissolve, making them harder to snort or inject. They said those changes represent a “meaningful incremental improvement,” over the original OxyContin launched in 1996.
Data submitted by Purdue showed both prescribing and illegal trafficking of OxyContin decreased after the company pulled and replaced the original version of the drug.
But panelists said it was impossible to decipher whether those positive trends were due to the reformulation or a host of other factors affecting opioid use, including government crackdowns on pill mills and an influx of illegal opioids like heroin and fentanyl.
Several studies suggest many people who abused OxyContin switched to generic pain pills or illicit opioids, but patterns of switching varied widely across the country and populations, further blurring the drug’s overall impact.
Purdue said in a statement following the meeting it would continue to work with the FDA as it reviewed the OxyContin studies. The company declared bankruptcy last year in an effort to settle thousands of lawsuits accusing it of over-promoting OxyContin and misleading the public about its risks.
Vaping by US teenagers fell dramatically this year, especially among middle schoolers, according to a federal report released Wednesday.
Experts think last year’s outbreak of vaping related illnesses and deaths may have scared off some kids, but they believe other factors contributed to the drop, including higher age limits and flavor bans.
In a national survey, just under 20% of high school students and 5% of middle school students said they were recent users of electronic cigarettes and other vaping products. That marks a big decline from a similar survey last year that found about 28% of high school students and 11% of middle school students recently vaped.
Survey
The survey suggests that the number of school kids who vape fell by 1.8 million in a year, from 5.4 million to 3.6 million, officials said.
But even as teen use declined, the report shows a big bump in use of disposable e-cigarettes. The Food and Drug Administration earlier this year barred flavors from small vaping devices like Juul and others that are mainly used by minors. The policy did not apply to disposable e-cigarettes, which can still contain sweet, candylike flavors.
“As long as any flavored ecigarettes are left on the market, kids will get their hands on them and we will not solve this crisis,” Matt Myers of the Campaign for Tobacco Free Kids said in a statement.
The national survey is conducted at schools each year by the Centers for Disease Control and Prevention and usually involves about 20,000 middle and high school students. It asks students if they had used any vaping or traditional tobacco products in the previous month. The survey was cut short this year as schools closed because of the coronavirus pandemic.
Federal health officials believe measures like public health media campaigns, price increase and sales restrictions deserve credit for the vaping decline. The age limit for sales in now 21.
But they also acknowledge the outbreak probably played a part. The CDC’s Brian King said sales started falling in August — when national media coverage of the outbreak intensified.
“It’s possible that some of the heightened awareness could have influenced decline in use,” said King.
By the time the outbreak was winding down early this year, more than 2,800 illnesses and 68 deaths had been reported. Most of those who got sick said they vaped solutions containing THC, the ingredient that produces a high in marijuana. CDC officials gradually focused their investigation on black market THC cartridges, and on a chemical compound called vitamin E acetate that had been added to illicit THC vaping liquids.