The U.S. Food and Drug Administration (FDA) recently announced that the risks of narcotic painkiller Opana are greater than its potential benefits for patients. The FDA is urging the maker of Opana, Endo Pharmaceuticals, to take the product from the market. The main concern of the FDA is the potential for abuse and addiction and the fact that this harmful drug is leading to outbreaks of disease.
Advisory Panel Evaluates Opana
The announcement from the FDA came after an advisory panel convened by the agency evaluated the risks and benefits of the medication. Opana is an opioid painkiller with the generic name oxymorphone hydrochloride. Opioid medications come with a high risk of abuse and have led to a wave of addiction to painkillers and an epidemic of overdose deaths from both prescription opioids and heroin, an illicit drug that causes a similar effect in the brain.
Endo Pharmaceuticals recently reformulated Opana, which is an extended release form of the drug. Extended release formulations can be more susceptible to abuse because they carry larger doses in one pill than other formulations. When crushed, some of these pills release the full dose all at once. With the reformulation, however, it was supposed to be more difficult to abuse Opana.
The FDA advisory panel found that in spite of this reformulation, there is still a high potential for abuse and that the risks of the drug being on the market are not outweighed by potential benefits. The patients who should benefit from Opana are those with moderate to severe pain that requires 24-hour painkillers.
Addiction and Disease Outbreak
The FDA reviewed post-marketing data to evaluate the benefits and risks of Opana and found that there is significant abuse of the drug, and that the method of abuse changed after the drug was reformulated. Abusers were previously crushing and inhaling the pills, but the advisory panel found that there was a shift to injecting the crushed pills to abuse them. This was a way that abusers found to get around the reformulation.
This in turn has led to serious outbreaks of infectious diseases, including hepatitis C and HIV. In 2015 there was a particularly bad outbreak of disease in Scott County in Indiana. It is believed that the drug was overprescribed there and in other locations with a lot of abuse. The abuse of Opana is also linked to a blood disorder called thrombotic microangiopathy, and to addiction and overdose.
Taking Steps to Remove Opana from the Market
The advisory panel was the first step in getting Opana removed from the marketplace. The panel voted 18 to 8 that the drug does not provide enough benefits to outweigh its risks. The result of that vote is that the FDA has officially asked Endo to remove Opana. If Endo does not take this step willingly, the FDA has stated that it will take the official steps necessary to withdraw its approval of the drug, forcing it to be removed. In the meantime, doctors and other health professionals are being warned of the risks and are being discouraged from prescribing Opana if there are other options for patients.