Opioid painkiller Opana ER made NPR's news this week due to the fact that the dangers involved with taking the drug actually outweigh its benefits. Back in 2012, the ingredients in Opana ER were altered so as to make it harder to crush. The goal here was that abuse of the drug would potentially be reduced, since people could not snort it as easily. However, as with anything else, where there is a will, there is a way, and those who wished to abuse the drug soon figured out just how to do that: by dissolving it, and then injecting it like heroin.
Because of the increase in the number of injections in the area, Scott County, Indiana experienced a rash of 215 new HIV cases back in 2015. Nearly all of those infected had shared dirty needles containing the modified Opana ER. Those who were experienced at abusing opioids and who were interviewed on the subject of Opana ER said that the drug wasn't being injected until it was reformulated. So by attempting to combat abuse from one angle, the manufacturer (Endo) created an entirely different and potentially unforeseeable issue.
Indiana's state health commissioner, Dr. Jerome Adams, told the Food and Drug Administration advisory committee that it's time we ask ourselves whether we're helping more people than we're hurting, especially considering his proposition that Opana ER is being overprescribed. He also noted that the purpose of bringing up this HIV epidemic is not to reflect on what happened back then, but more to make sure that it doesn't happen again to another community.
The FDA reviewed the data among those who had reported abusing Opana ER and found that Scott County is not the only area with an increase in injections of the drug. In fact, overall injections of the drug more than doubled from 17 percent to 38 percent. What's especially disturbing about this is the fact that not only has Opana ER been linked to increased HIV cases, but it has also been linked to a rare blood disorder known as thrombotic thrombocytopenic purpura, as well as Hepatitis C.
While Endo said that the reformulation of Opana ER was intended to stop abuse of the drug, the company also had their own financial interests at heart. Per NPR, if generic versions of Opana were to enter the market, the company would see their annual net sales drop by about $135 million. However, there is a bright light at the end of the tunnel. This week, the FDA advisory committee – which included both doctors and researchers – voted "no" 18 to 8 on the question of "Do Opana ER's benefits continue to outweigh its risks?"
The eight folks who voted "yes" admitted to being concerned that removing Opana ER from the market would do nothing to stop the country's opioid epidemic from charging ahead because those who are currently abusing Opana ER would just move on to other drugs, like fentanyl and heroin. As of now, the timeline of the drug remains uncertain, however Endo posted a statement to their website saying that they "[believe] that Opana ER remains an important clinical choice for appropriate patients and will evaluate the range of available options for maintaining access for legitimate use."