The opioid epidemic in the U.S. is in full force. In a desperate effort to battle the outbreak, the FDA may require one drug company to discontinue selling its “abuse-resistant” opioids, stating that the product is not abuse resistant and has led to HIV and Hepatitis C outbreaks. The pharmaceutical company argues, however, that they will not be removing their drug from the market and that the FDA is misrepresenting the issue.
Tamper-resistant opioids are designed to disable crushing, snorting or injecting the drug to prevent misuse and addiction. The prescribing of tamper-resistant opioids has increased in the wake of the current opioid epidemic ravaging the U.S. As noted in a previous article by Liberty Nation, about two million Americans struggle with a prescription opioid addiction, and over twelve million have abused these medications within the past two years. Moreover, the prevalence of opioid-related overdoses has quadrupled since the year 2000.
Tamper-resistant opioids such as Opana ER, designed by Endo Pharmaceuticals, are meant to decrease the abuse of opioids. Opana ER was modified in 2012 when patients began crushing and snorting the drug to get high. Although the 2012 modification led to decreased abuse via snorting, patients struggling with opioid addictions have started cooking and intravenously injecting the medication much like heroin. The FDA claims that intravenous injections of Opana ER have led to severe HIV and Hepatitis C outbreaks; the administration is now pushing to require Endo Pharmaceuticals to have the drug taken off the market. Does the FDA have a point?
Diagnosis of Hepatitis C, including maternal Hepatitis C, has more than doubled since 2010. Doctors believe the increased prevalence of the disease to be a direct result of intravenous opioid abuse. Also, misuse of Opana ER is thought to be the reason for the 2015 HIV outbreak in Indiana, as noted by National Public Radio. As a result, the Advisory Committee of the FDA, an independent group of experts that offers advice to the administration, voted eighteen to eight that the risks of Opana ER outweigh the benefits. Endo Pharmaceuticals argues, however, that over half of the Advisory Committee also expressed their wishes for Opana ER to remain on the market, in contrast to the demands of the FDA.
As reported by USA Today, many doctors believe that Endo Pharmaceuticals are not to blame for the opioid epidemic, but that doctors are overprescribing the medication. Instead of removing the drug from the market, many doctors feel that Endo Pharmaceuticals should improve labeling of Opana ER to educate prescribers on the dangers of intravenous abuse of the drug. Dr. Andrew Kolodny, Executive Director of Physicians for Responsible Opioid Prescribing, says that Opana ER is misleadingly labeled to be "abuse-resistant" and that the company should instead state that the drug is only “crush resistant.”
According to the Canada Medical Association Journal, a peer-reviewed scientific publication, tamper-resistant opioids are not the answer to solving the opioid epidemic. As seen in the case with Opana ER, making so-called abuse resistant medications does not absolve all addictive qualities of the drugs. Patients can no longer snort Opana ER but can inject it intravenously. The FDA's attempt to require removal of Opana ER from the shelves is not the answer to ending the opioid epidemic, as removal will only result in abuse of another prescription opiate. As reported in a previous LN article, opioids have particularly addictive qualities in the brain due to its opium receptors, making such addiction extremely challenging to treat. To prevent addiction, increased education on opioid abuse is also necessary. Also, doctors should closely monitor those prescribed opiates or use alternative medications or therapies. The overprescribing by doctors must cease.
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