This week I want to share two articles that highlight the challenges with trading opioids for another prescription painkiller. The first article is about gabapentin and how evidence of abuse is driving it towards being a controlled substance. The second article is about tramadol and the potentially dangerous – or no – effects it has. Below you’ll find these articles and my thoughts on their implications.
Disclaimer: The views and opinions expressed below are those of Mark Pew, Senior Vice President of Product Development and Marketing, and do not necessarily reflect the views of Preferred Medical.
Gabapentin, a drug commonly used to treat seizures and nerve pain, may be soon added to the list of controlled substances in Ohio. Over the last several years the drug has been sold on the streets to enhance highs and help with symptoms of withdrawal from other drugs. Additionally, people are mixing it with heroin and other opioids which creates a dangerous, potentially deadly mix. Several other states have already made it a controlled substance.
There is growing evidence and acceptance that pregabalin (e.g. LYRICA) and gabapentin (e.g. Neurontin) are drugs of abuse. But they’re potentially dangerous for other reasons. The FDA label for LYRICA includes “Suicidal Thoughts or Actions.” A 2019 Swedish study of gabapentinoids found user’s risk was “26% higher for suicidal behavior or suicide, 24% higher for accidental overdose, 22% higher for head or body injuries, and 13% higher for car crashes and traffic offenses.” Even with those risks they have been Top 10 in utilization and cost in Work Comp for the last decade, often as alternatives to Rx opioids. I said this on 7/30/19 when generic LYRICA was introduced: “It’s not just about pricing. It’s also about medical appropriateness. A lower price is great. But does the drug actually help that individual?” The DEA already lists pregabalin as a Schedule V drug but it would not be surprising to see them increase that to a higher level. Given the abuse potential an argument could be made for Schedule III (“moderate to low potential for physical and psychological dependence”) or even Schedule II (“high potential for abuse, with use potentially leading to severe psychological or physical dependence”). It would also not be surprising to see the DEA add gabapentin as a controlled substance at some point. The United Kingdom made both gabapentin and pregabalin a controlled substance (Class C) as of April 1, 2019 due to the abuse they saw of both medications. Interestingly, three of the states at the epicenter of the opioid epidemic – Kentucky, Tennessee, West Virginia – have all made gabapentin a controlled substance while Ohio has it on the watch list for drugs of abuse. The people and governments of those states have a heightened awareness of the dangers of prescription medication abuse thanks to Big Opioid Pharma. It would not be surprising to see more states follow their lead. I will leave you with what I wrote on 8/16/19: “Every single medication has a (sometimes long) list of potential side effects. Regardless of the drug, you should read that list. Every time. If the potential (or real) risks exceed the benefits, you need to find something else.”
The FDA recently had a split vote over whether to approve a combination drug containing tramadol. Several groups and physicians opposed it because of the dangers that many physicians do not know about. Tramadol is a lower potency opioid (it has a 0.1 MED factor compared to OxyContin whose MED factor is 1.5). The effects vary from person to person, with some receiving pain relief and a euphoric high and others absolutely nothing. It can cause the same effects of other opioids—addiction, suppressed breathing and death—as well as seizures and low blood pressure.
Do you take Tramadol? Do you pay for somebody’s Tramadol? “Tramadol is an unreliable painkiller. That’s because 1 in 14 people lack the enzyme to transform tramadol to its most active form, so they won’t get either pain relief or a high from the drug.” Beyond the fact that it may not be effective, “Historically ‘safer’ tramadol more likely than other opioids to result in prolonged use” outlines a May 2019 study by the Mayo Clinic with this interesting quote:
“This data will force us to reevaluate our postsurgical prescribing guidelines,” says lead author Cornelius Thiels, D.O., a general surgery resident in Mayo Clinic School of Graduate Medical Education. “And while tramadol may still be an acceptable option for some patients, our data suggests we should be as cautious with tramadol as we are with other short-acting opioids.”
Tramadol is often in the Top 20 of Work Comp drugs. It has also historically been one of the drugs most often physician dispensed. The DEA made Tramadol a Schedule IV controlled substance effective August 18, 2014 but the scientific evaluation process started in 2010. Comments in support of its inclusion in the CSA mentioned the possibility of abuse, it being a “loop hole” drug, and how those issues were often overlooked by patients and prescribers because it was not a controlled substance (i.e. it was assumed safer than it might have been). Comments against focused primarily on reduced elderly access to pain medications, scientific data was not sufficient, and it’s not really an opioid. The DEA strongly differed with each of those positions and moved forward with it as Schedule IV. So for the reasons listed above (and more), be careful with Tramadol. It may not be what you think it is.
To read everything on my mind this past week, please visit me on LinkedIn at https://www.linkedin.com/pulse/marks-musings-february-17-mark-rxprofessor-pew/.
Until Next Week,