For the first time in the history of the Food and Drug Administration, they have asked a drug maker to stop selling a potent opioid painkiller. The request went out to the maker of a specific opioid medication asking them to voluntarily stop the sales of the potent painkiller called Opana ER. The FDA has studied its potential for abuse and they feel the dangers of this drug far outweighs its benefits.
The drug is made by the Ireland-based drug manufacturer Endo Pharmaceuticals and the FDA has requested that they stop selling a reformulated version of the opioid drug Opana ER. ER stands for extended release, as this drug in pill form delivers the medication to the patient’s system over a prolonged length of time. The FDA has seen a “significant shift” from the original intended use of the drug to people now crushing Opana for snorting and injecting this powerful medication to get high, according to the Chicago Tribune.
The ease of ability to crush this drug and then use it for snorting or to dissolve the drug in water and use it in needles has created a high incidence of overdoses. There is a lot of pain medication in one pill, but this pain medication is formulated to deliver small doses into a patient’s system over a period of 10 to 12 hours, according to the Opana ER website. Opana was designed to offer a sustained amount of pain relief for that long period of time to someone who suffers from chronic pain. When the pill Opana is crushed, that delivery system vanishes. By snorting or injecting the crushed pill, a massive amount of the Opana pain medication is introduced into the person’s system all at once, which comes with a high risk of causing an overdose.
The drug Oxycontin, which is reformulated oxycodone, is also delivered into the system in a time-release fashion. Oxycontin had similar problems years back, as it was also originally easy to crush for snorting and injecting. According to Pop Science, the company reformulated the drug back in 2010 so it is tamper proof and it can’t be used in any other way than its original intended use.
In order for someone to inject a pill, it has to be crushed and dissolved in water. When Oxycontin is put in water it turns to a gell-like substance making it impossible to inject. For snorting a drug, that drug needs to be in powder form. The Oxycontin pill is also formulated so it can’t be crushed fine enough for snorting purposes. If a drug user tries to crush the pill it breaks into chunks and those pieces aren’t fine enough for snorting the drug through the nose.
The Opana drug, which is reformulated Oxymorphine, was supposed to act much like the reformulated Oxycodone pill. The difference is that the Opana ER drug does not work at safeguarding against crushing and dissolving, making it a drug easily prepared to snort or inject. This is the reason the FDA has deemed the drug at risk for abuse and at risk for overdosing, prompting the federal agency to ask that the company to stop selling the pain medication.
The “unprecedented” opioid epidemic, which is how the federal Department of Health and Human Services describes the overwhelming use of opioid drugs in this country, is the reason behind this request, according to USA Today. The FDA has to take this step to help safeguard against overdose and abuse. The ability to crush the Opana ER pill makes it one of the more riskier drugs on the market when it comes to having the potential for an overdose.
Not only are the dangers of overdosing high with this drug when snorted or injected, but this painkiller has spawned a surge in HIV and Hepatitis C cases among its users who are using needles to inject the crushed and dissolved Opana, according to Marketwatch. If the maker of the drug voluntarily takes Opana off the market, this is one small step in the opioid epidemic.
The drug companies are big business, so the stocks for Endo took a hit once this FDA request was revealed to the public this week. On Thursday the stocks dipped close to 13 percent, down to $11.99 a share, according to USA Today.
[Featured Image by Rich Pedroncelli/AP Images]