FDA's Investigation of Gabapentinoid Abuse Stirs Controversy Among Pain Management Specialists

FDA's Investigation of Gabapentinoid Abuse Stirs Controversy Among Pain Management Specialists

The FDA's recent announcement of a new enquiry into the risks of abuse of gabapentinoids has generated a flock of comments from doctors - some pro and some con.

Gabapentin and pregabalin are collectively referred to as "gabapentinoids." Pregabalin is marketed as Lyrica and Lyrica CR, and gabapentin is known by the brand name Neurontin. These drugs are approved to treat a variety of painful conditions including post-herpetic neuralgia, fibromyalgia and the neuropathic pain associated with diabetes. And millions of patients depend on them for relief without risking opioid dependence.

On one hand, we have FDA Director Scott Gottlieb saying that "some literature suggests that clinicians may be prescribing these drugs off-label ... as alternatives to opioids, outside approved indications." Gottlieb stated this at a meeting here on safe opioid prescribing, sponsored by the Duke Margolis Center for Health Policy.

But on the other hand, say some doctors, gabapentinoids are not opioids, so why are they being discussed at a meeting on safe opioid prescribing?

Gottlieb says: "Our preliminary findings show that abuse of gabapentinoids doesn't yet appear to be widespread, but use continues to increase, especially for gabapentin. FDA is investigating whether abuse or misuse is also increasing and if so, what should be done to address this problem."

As reported by MedPage Today, Gottlieb admitted that the research data so far are "limited" but that they do suggest that gabapentinoid abuse and misuse "may be growing, both [when] taken alone and in combination with opioid, benzodiazepines, or other central nervous system depressants."

"We're concerned that abuse and misuse of these drugs may result in serious adverse events such as respiratory depression and death," Gottlieb said. "We want to understand changes in how patients are using these medications. We've looked at social media websites where opioid users share comments and describe methods and motivations for abusing or misusing gabapentinoids.

"We've tasked our surveillance epidemiology group at FDA ... with investigating use of gabapentinoids. We'll have more to say about this challenge soon ... We know we need to investigate and respond to signs of abuse as soon as signals emerge; we need to get ahead of these problems."

The doctors respond

Thousands of pain management physicians rely on gabapentinoids to treat otherwise intractable pain, many of whom are also trying to avoid using opioids. As a result, many doctors - but not all of them - are loudly opposed to any attempts by the FDA/DEA to up-schedule or limit access to the gabapentinoids.

Here are a few of the two dozen physician comments replying to the MedPage Today article about the FDA investigation:

Dr. M.S (con):

"This is plain ridiculous in the sense that Gabapentin itself is extremely hard to abuse due to the method of action it takes in the body. The body blocks large doses from entering the gaba recepting nerve blocks and if a patient abuses it the bioavailability of it goes down. There have been countless studies of this and this is why a person would have to be taking 50 grams per dose to even try anything overdose [sic] and then it would be more of a blocked airway due to hundreds of pills/caps choking them to death. Lyrica is semi the same, just the bioavailability of it does not take as sharp of turn downwards. These medications are life lines to millions of suffering people and abuse is next to non-existent. What next the Gabademic?"

Dr. T.S. (pro):

It is not only abusable, it is being abused. It is already a controlled substance in Kentucky. I've had multiple patients admit to gabapentin abuse. I have admitted several patients primarily for gabapentin abuse. In addition there was a recent study in March 2017 showing that opioid abusers on gabapentin die at four times the rate of opioid abusers not on gabapentin. Another recent study showed that gabapentin inhibits the brain's ability to form new synapses. I don't understand why people are still defending gabapentin. I assume they're not reading the same literature I am.

Dr. A (con):


Consider these two questions:

1) What is the black market value of Gabapentin and Lyrica?

2) How many people end up at the Betty Ford Rehab from Gabapentin and Lyrica abuse?

...It's fairly easy to determine if a drug has an abuse potential ... I was a biochemist before I was a doctor. I understand pharmacokinetics. I object to the commercials on TV stating its scheduled V status may cause abuse. This is like telling a person they can get high with canned whipped cream or playing games with laundry detergent pods. You aren't going to get high with either, and both will kill you slowly or quickly in other ways. Stupid humans always ruin it for legitimate cases.

Dr. Dave (mostly pro):

Scott is NOT looking at the additive ratio of the drugs he is looking for the addictive POTENTIAL for the class. It is well known that anything that continuously reduces pain in a population of pain-ridden people will become addictive by them. Addictive being defined as a requirement for more and or increased doses to remain pain-free (or in the case of the street user the ability to feel above normal). Here we have a crappy set of drugs with minimal acceptance in the prescribing community vs. a BIG monster on our back (the opioids). So what do we do?... I am GUESSING that Scott's concerns are that the profession will arbitrarily shift to the Gaba train to avoid the Opioids and the hysteria of the "epidemic addiction cycle" and will start another issue that he has to reign in by 2020.

"NO doubt that GABA is not the place to look for the next OxyContin but who would have guessed that anyone would have thought to lace Heroin with Fentanyl to get more sales? Addicts are addicts PERIOD...We need to cough up research money not treatment money since treating with the current information is futile. We need BETTER information to properly treat this "epidemic."

Everyone is different

Here at Novus, we've learned how remarkably different each person can be in their uses of various substances, and how their responses to them are always unique. That's why we approach every new patient as a brand new case, and why our success ratios are so far above the average.

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