In July, 2017, a Food and Drug Administration advisory board made up of doctors and researchers voted 18-8 to pull Opana ER from the market, based upon findings that the risks of the drug outweighed the benefits. The FDA made a statement that this was the first time they had taken the unusual and dramatic step of removing a drug this way, saying that there was far too great a risk of abuse.
What is Opana ER?
Opana ER is an extended-release drug meant to help with moderate to severe pain. Originally intended to be taken orally, Opana ER contains oxymorphone, which is a semi-synthetic opioid.
Opioids are a class of drugs which are commonly used for pain relief, and are often safe if taken for a short period of time, as prescribed, under a doctor’s supervision. Examples of some common opioids include heroin, codeine, morphine, hydrocodone and fentanyl. Despite proper use, however, regular use of opioids can lead to dependence, overdose, and even death.
Why is Opana ER so prone to abuse?
Opioids not only relieve pain, they provide a feeling of euphoria and well-being to users. This can lead to users taking a higher dosage than needed, or more often, and spur the initial emotional and psychological addiction.
As a potent opioid painkiller, Opana ER is twice as strong as a similar dose of OxyContin, and can provide up to 12 hours of pain relief, which can be convenient for patients but which may help lead to addiction.
How is Opana ER taken
The designers of Opana ER meant for it to be taken orally, in pill form. Drug abusers figured out that it could provide a much greater effect if it was crushed and then snorted. The makers of Opana ER, Endo Pharmaceuticals, reacted by making the pill crush-proof. Unfortunately, users of the drug found a new way to get a more potent high, which came with devastating consequences.
Injection of Opana ER and disease outbreaks
In order to continue to abuse the drug, users started injecting the drug, which led to sharing of syringes. Because they were under the effect of this very potent drug, their behavior was riskier than normal. No one realized what was going on until doctors started noticing disease patterns.
Rural New York doctors in 2012 noticed a large number of cases of Hepatitis C in Opana ER users. Spread by contact with an infected person’s blood, Hepatitis C can cause liver failure and liver cancer. Doctors in Tennessee found a group of users with a rare blood disorder. In 2014 and 2015, doctors in Southern Indiana discovered that there was an unprecedentedly large number of people with HIV infections, with no other risk factors besides the injection of Opana ER.
The FDA decision
FDA Commissioner Scott Gottlieb, M.D. issued a statement saying, “We are facing an opioid epidemic—public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse.” Only approved in 2006, Endo Pharmaceuticals had to change the formula in 2012 to try to make it invulnerable to physical and chemical manipulation.
The company tried to save the drug by requiring labeling which warned of the potential for abuse, but after a risk analysis, the FDA instead asked them to voluntarily recall the product.