Big news came out of Washington, DC yesterday that did not involve our president. The FDA has asked Endo Pharmaceuticals to remove Opana ER from the market. If the manufacturer refuses to do so, then the FDA will rescind its approval of Opana ER and force removal of this deadly medication.
FDA Commissioner Dr. Scott Gottlieb said. "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."
This is great news! Let’s hope the FDA continues to apply this standard to all medications currently on the market. The truth is, NONE of the long acting opioid pain medications have a favorable risk-benefit ratio. The CDC has said that long-acting opioids should not be used for acute pain (Dowell, Haegerich, & Chou, 2016). In addition, no studies have shown that opioids are effective for use in chronic pain when used for more than 16 weeks. Even those studies – done by the drug companies themselves – did not show clinically significant improvement (Shaheed, Maher, Williams, Day, & Mclachlan, 2016). As we all know, more people die from opioids than any other medication.
I must admit that I was not a big fan of the appointment of Dr. Gottlieb to the FDA. I am, however, impressed with this action taken so early in his tenure. Let’s hope that this is an indication of the FDA’s resolve to look honestly at these medications. Only in rare situations are the benefits of long-term opioid therapy for chronic pain expected to exceed the risks. For those who are already on Opana ER and other long-acting opioids, changing them to buprenorphine will usually result in better pain relief and a much safer opioid (Daitch et al., 2014).
With the recent news in the New York Times that opioid overdoses continued to increase in 2016 at a record rate, it is evident that we need to do more to reverse the opioid epidemic. Removing these lethal drugs from society will be an important step toward that goal.
Good work, Dr. Gottlieb!
Daitch, D., Daitch, J., Novinson, D., Frey, M., Mitnick, C., & Pergolizzi, J. (2014). Conversion from high-dose full-opioid agonists to sublingual buprenorphine reduces pain scores and improves quality of life for chronic pain patients. Pain Medicine (United States), 15(12), 2087–2094. http://doi.org/10.1111/pme.12520
Dowell, D., Haegerich, T. M., & Chou, R. (2016). CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR, 65. http://doi.org/10.1001/jama.2016.1464
Shaheed, C. A., Maher, C. G., Williams, K. A., Day, R., & Mclachlan, A. J. (2016). Efficacy, Tolerability, and Dose-Dependent Effects of Opioid Analgesics for Low Back Pain A Systematic Review and Meta-analysis. JAMA Internal Medicine, 176(7), 958–968. http://doi.org/10.1001/jamainternmed.2016.1251