After a report last week by the New York Times that the number of overdose deaths increased roughly 20% from 2015 to 2016, many states are scrambling to come up with answers to solve this epidemic. The target of the debate is powerful prescription painkillers called opioids. Pharmaceutical companies have come under fire recently, especially by the State of Ohio, for marketing the drugs for chronic pain. Many speculate that the increase in opioid prescriptions is a major cause of the overdose epidemic. In response to the drastic increase in death, the federal government has taken action to remove a powerful drug from the market: Opana.
The FDA
Last week the Food and Drug Administration ordered Endo Pharmaceuticals to remove Opana ER from the market. The FDA noted that this is the first time it is directing the removal of an opioid medication due to the public health crisis associated with prescription drug abuse.
The FDA Commissioner, Dr. Gottlieb, stated “We are facing an opioid epidemic — a public health crisis — and we must take all necessary steps to reduce the scope of opioid misuse and abuse. We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
Many doctors are pleased with the decision, but many believe it is not enough. Opana is just one opioid of many which have been under scrutiny. Endo Pharmaceuticals was already trying to curb abuse rates by restructuring the pill. The manufacturer added a hard coating to prevent the drug from being crushed, but it simply was not enough to stop people from abusing the drug. Even after the new pill design in 2012, the FDA refused to approve a label for the drug which stated it had abuse-deterrent properties.
This removal is likely the first step in a trend of stricter FDA policies. The FDA states that “[The FDA] will continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.”
The FDA claims that the order is a request for voluntary removal by Endo, but also stated if the company refuses to comply, the agency will take action to forcibly remove the drug.
What Is Opana?
Opana is a prescription opioid often prescribed for chronic severe pain. It is about twice as powerful as OxyContin and generally restricted to patients who require around-the-clock pain management. The medication is supposed to be a drug used as a last resort, but with over 1 million doctors in the country, this can be hard to regulate.
When abused, the pill is often crushed into powder to insufflate, inject, or to disable its extended-release properties. The FDA found that after the new pill formulation in 2012, drug abusers were injecting the drug more often than before the change. The FDA states that this increase in injection drug use has lead to an increase in HIV and Hepatitis C transmission.
This is not the first time Opana received severe scrutiny. In 2015, Opana was the center of debate during a sudden outbreak of HIV in a small Indiana town. The FDA believes that the new pill formulation, intended to prevent abuse, actually directly caused the outbreak due to the increase in injection rates. 142 people were diagnosed with HIV in one town.
The FDA believes that, after careful review, the painkiller’s benefits no longer outweigh the risks. Regardless of this removal, there are still many powerful opioid painkillers which can take the place of Opana. Some fentanyl analog drugs, often the culprit in opioid overdose deaths, are still FDA approved. These drugs are 10,000 times more powerful than morphine and are used to lace heroin and counterfeit pills. Fentanyl is on the market as a transdermal patch, similarly prescribed for severe chronic pain.
Endo Pharmaceuticals has not formally agreed to comply with the order. Endo stated “Despite the FDA’s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed. Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.”
According to NBC News, Endo sold $158 million worth of Opana ER in 2015. According to the Ohio Attorney General, the head of the lawsuit against several pharmaceutical companies including Endo, pointed out that four out of five individuals suffering from heroin addiction first started with prescription opioids.
The State of Ohio claims that these drug manufacturers intentionally exaggerated the benefits of opioids while understating the risks. The State also claims that the companies engaged in fraudulent marketing tactics and bribery to gain popularity for the drugs.
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