FDA Seeks To Remove Opana ER From Market

Opioid prescriptions decline in Oregon

For the first time, the Food and Drug Administration has requested that a prescription opioid be removed from the market. 

On June 8, the FDA announced in a press release that for reformulated Opana ER — a time released semi-synthetic opioid — risks outweigh its benefits. 

The agency cited a major outbreak of HIV in rural Indiana associated with the drug as a factor in the decision.

“We talked about, at the advisory committee meeting, looking at the generic version of oxymorphone immediate release and extended release, so that’s something we are still evaluating,” says Sarah Peddicord, a press officer with the FDA.

An Oregon law aims to thwart opioid addiction by regulating prescription practices. The state’s Prescription Drug Monitoring Program requires that all schedule II, III and IV drug prescriptions be entered into a database. The PDMP quarterly report released in March shows a drop in top prescribed opioids such as hydrocodone, oxycodone, morphine and tramadol compared to 2016 — both morphine and hydrocodone prescriptions dropped by more than 12 percent. 

In 2016, the Centers for Disease Control released new guidelines for prescribing opioids because the agency found no evidence of “long-term benefits of opioid therapy for chronic pain.” Opioid addiction is a national public health epidemic and both the FDA and the CDC have formed specialized committees to evaluate and address the crisis. 

While opioid prescriptions are on a downward trend, the latest statistics in Lane County show that approximately 36 people died every year from opioid overdoses alone from 2013 through 2015, according to Lane County Public Health.

“At a population level, we are seeing deaths by overdose achieving the numbers once only reserved for deaths by car accidents,” Lane County Public Health Officer Dr. Patrick Luedtke writes in an email. 

Dwight Holton, CEO of Lines for Life, a suicide and drug prevention nonprofit, says the FDA’s decision could lead to safer prescribing practices. 

“I think one of the big, evolutionary changes that we are seeing is a shift from even a year ago… has shifted to an understanding that opioid prescribing for chronic pain is simply not safe,” Holton says. “And that rather than needing to take care in our approach to opioid prescribing for chronic pain, more and more prescribers are beginning to believe that giving a chronic pain patient an opioid is not doing them a favor — it’s putting them at risk.” 

Holton says the nonprofit is supportive of Oregon House Bill 3440, which would allow the Oregon Health Authority to use the PDMP system to “determine whether practitioners are prescribing opioids or opiates in compliance with guidelines,” according to the bill’s summary.

Additionally, HB 2645, which is geared toward addiction prevention, would require drug manufacturers to develop drug take-back programs and have disposal boxes for customers to drop off their unused prescriptions. 

Holton says many opioid addictions begin from unfinished prescriptions in medicine cabinets. According to data from Lane County Public Health, the addictions of four out of five current heroin users stem from first using prescription opioids.

In Scott County, Indiana, the Center for Disease Control found that of the 31 people surveyed in its Opana ER study, 17 were HIV positive and 28 were positive for Hepatitis C. Most interviewees also reported sharing “a quarter of a pill injection with two to four partners,” according to CDC Outbreak Investigations Involving Opana ER. 

As far as assessing other opioids, Peddicord says “it’s premature for us to speculate on any other opioids at this time.” 

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