A First! FDA Requests Withdrawal of Opana® ER from the Market

Monday, June 12, 2017

In the midst of an “unprecedented opioid epidemic” (per the federal Department of Health and Human Services), the U.S. Food and Drug Administration (FDA) asked for withdrawal of Opana® ER from the market, a first ever! FDA Commissioner Scott Gottlieb states the opioid epidemic is a public health crisis and all necessary steps must be taken to reduce the scope of opioid misuse and abuse.

On March 13-14, 2017, an independent FDA advisory committee met to discuss the abuse patterns and other safety concerns related to Opana® ER (oxymorphone hydrochloride extended-release [ER] abuse-deterrent tablet), and voted 18-8 that the benefits of Opana® ER no longer outweigh its risks. In June 2017, the FDA requested that Endo Pharmaceuticals, marketer of Opana® ER, remove it from the market.

The FDA states an increasing number of people are abusing the powerful prescription pills by crushing, dissolving and injecting them. A likely contributing factor is the major drug interaction of alcohol with Opana® ER. Co-ingestion of alcohol (as little as 4%) with Opana® ER has resulted in significantly elevated oxymorphone levels causing additive central nervous system depressant effects, respiratory depression, hypotension, profound sedation or coma which may potentially lead to fatal overdose. Furthermore, warnings on Opana® ER indicate that the abuse-deterrent tablets are to be swallowed whole, and are not to be broken, chewed, crushed or dissolved; or it could lead to the rapid release and absorption of a potentially fatal dose of oxymorphone.

What are best practices?

  • Use first-line agents, with opioids as a last resort, and prevent progression to long-acting opioids

o   Non-opioid adjunctive therapy is preferred for chronic non-cancer pain and therapy should be optimized

  • Risk stratify patients to determine level of risk and if they are an opioid candidate

o   Do the benefits outweigh the risk?

  • Use the lowest effective dose

o   Adjunctive non-opioid therapy has an opioid-sparing effect

  • Continuous re-evaluation of efficacy

o   Clinically meaningful improvement in function?

  • Set goals with an associated timeline

o   Opioids should be viewed as a trial with an exit strategy

  • Close monitoring of compliance with the pain management treatment plan

o   Physician-patient contract, drug screens, prescription drug monitoring program, pill counts, pain diary

  • Periodic reassessment to evaluate for an opioid taper

What is next?

OxyContin® (oxycodone ER)? Net worth of $14 billion in less than two decades.

The list of lawsuits against Purdue, the manufacturer of OxyContin®, gets longer; including the city of Everett in Washington State, Orange County of California, city of Chicago and the state of Mississippi.

By Nahla D. Rizkallah, PharmD, MSCC – Senior Clinical Pharmacist for ExamWorks Clinical Solutions

ExamWorks Clinical Solutions is the industry leader in MSP Compliance, Case Management and cost mitigation.  Please contact us to learn more about our full suite of Pharmacy mitigation programs to protect the patient, return them to gainful employment, or assist with mitigating Medicare Part D costs.

About the author

Nahla D. Rizkallah, PharmD, MSCC, is Senior Clinical Pharmacist at ExamWorks Clinical Solutions (ECS). In this capacity, she performs prescription analysis to optimize drug therapy using evidence-based guidelines and national guidelines and participates in physician outreaches to implement the recommendations. She has 27 years of experience in various area of pharmacy practice including review of Part D medications on Medicare Set-Aside Allocations, Pharmacy and Therapeutics Committee, Pharmacy Manager for a closed mental health facility, Pharmacy Manager for the indigent, staff/clinical pharmacist for assisted-living facilities (ALFs), medication audits for ALFs, drug information center, clinical pathways, staff education, and surgical/medical pharmacy satellite at All Children’s Hospital. Dr. Rizkallah received her Doctorate from the University of Florida in Gainesville followed by a one-year American Society of Health-System Pharmacists accredited residency.