In 1995 we were introduced to a new chronic pain management medication that was marketed inappropriately and eventually became a national problem. The medication was OxyContin. Now fifteen years later we have a new medication much more potent than OxyContin, and unlike OxyContin’s once every twelve hour formula this new medication is once every twenty-four hours.
This new medication is named Exalgo™ and is time-release hydromorphone. It was approved by the US Food and Drug Administration (FDA) on March 1, 2010. Exalgo™ is the only extended release (ER) formulation of hydromorphone available in the United States.
Presenting at the American Pain Society’s 29th Annual Scientific Meeting, Perry G. Fine, MD, of the Pain Research Center at the University of Utah’s School of Medicine, Salt Lake City, provided an update on the management of moderate to severe pain, with the goal of achieving around-the-clock relief. He focused specifically on Exalgo™, a once-daily novel treatment for chronic pain that delivers hydromorphone via the OROS delivery system, which uses osmosis to provide a steady rate of drug release. Exalgo™ is available is 8, 12, and 16 mg tablets.
I am very concerned as this medication is meant for someone who has been on strong opioid management for a long period of time. As a matter of fact the manufacturer—Covidien—posts the following warning for their product.
The indication for EXALGO is once daily administration for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. EXALGO is contraindicated in opioid non-tolerant patients, in management of mild pain or pain not expected to persist, in patients with compromised respiratory function or in patients with narrowed or obstructed gastrointestinal tract or with known hypersensitivity to any components including hydromorphone hydrochloride and sulfites. Concurrent use of EXALGO with CNS depressants, including alcohol, increases risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. Not recommended in patients who have received MAO inhibitors within 14 days of starting EXALGO.
A major reason for my concern is that opiate-naïve patients would be at serious risk for an overdose and could die. In addition, there is an even greater possibility for people to divert this drug for illegal sale; which could also lead to many more overdose cases and deaths.
However having shared my concerns, I also want to share my hope. My belief is that no medications are “bad” but how they’re used and who they are used with can either help or harm. We need to be vigilant and use a multidisciplinary team in collaboration with the patients and their family members to monitor any potentially risky medication like OxyContin or Exalgo. We also need to make sure the medication is not being abused or used to cope with psychological, emotional or lifestyle problems. We need to teach everyone on the team how to recognize red flags for medication abuse or addiction.
To learn more about potential medication problems in chronic pain management please check out my article Addressing the Problem of Perscription Drug Abuse/Addiction in Chronic Pain Management that you can download for free on our Article page.
If you’d like to receive training for helping people with chronic pain and coexisting disorders, including addiction, I’m very excited to announce we are presenting my Addiction-Free Pain Management® Certification Training in Sacramento on August 5-7, 2010. To learn more about this and my other upcoming trainings you can check out our Calendar page.
You can learn more about the Addiction-Free Pain Management® System at our website www.addiction-free.com. If you or a loved one is undergoing chronic pain management, especially if you’re in recovery or believe you may have a medication or other mental health problem and you want to learn more effective chronic pain management tools, please go to our Publications page and check out my books; especially the Addiction-Free Pain Management® Recovery Guide: Managing Pain and Medication in Recovery. To purchase this book please Click Here.
To read the latest issue of Chronic Pain Solutions Newsletter please click here. If you want to sign up for the newsletter, please click here and input your name and email address. You will then recieve an autoresponse email that you need to reply to in order to finalize enrollment.
To see an online overview of a web-based delivery of Addiction-Free Pain Management® please go to this Link for a free demo.