Ducttape

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in case you didn't see this last Thursday...


Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Drug Safety Communication - Serious Breathing Problems
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[Posted 12/19/2020]
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: FDA is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function. The elderly are also at higher risk.
FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids. FDA has also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.
BACKGROUND: Gabapentinoids are FDA-approved to treat a variety of conditions including partial seizures and nerve pain from spinal cord injury, shingles, and diabetes. Other approved uses include fibromyalgia and restless legs syndrome. Gabapentin was first approved in 1993 and pregabalin was first approved in 2004.
RECOMMENDATION: Patients and caregivers should seek medical attention immediately if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening. Symptoms to watch for include:
  • Confusion or disorientation
  • Unusual dizziness or lightheadedness
  • Extreme sleepiness or lethargy
  • Slowed, shallow, or difficult breathing
  • Unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up
  • Bluish-colored or tinted skin, especially on the lips, fingers, and toes
Always inform your health care professional about all the drugs you are taking, including prescription and over-the-counter medicines and other substances such as alcohol.
Health care professionals should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other central nervous system depressant such as a benzodiazepine.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the addressed on the form, or submit by fax to 1-800-FDA-0178
[12/19/2019 - Drug Safety Communication - FDA]
 
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Orin

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No. Anything that acts to reduce neural activity or excitability will likely act synergistically with opioids to cause worsening respiratory function. Let's just skip ahead to magnesium supplements having an FDA warning.

With that said, gabapentinoids are rather weak agents and I suspect my patients will demand they be stopped as they're "not sure if it's doing anything" but it might kill them.
 
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lobelsteve

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Brought market in 1994 in USA. But all of a sudden....

2 years of targeted articles in media about abuse and side effects.
Its the person and not the drug.
 
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ragnathor

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Brought market in 1994 in USA. But all of a sudden....

2 years of targeted articles in media about abuse and side effects.
Its the person and not the drug.

Agreed. I've had one patient I had to take off gabapentin since he was addicted - kept calling for early refills, lost his rx in the lake, stolen, etc.

Still I see every patient referred for "sciatica" on gabapentin so I make an effort to titrate up or taper off if not helping.
 

Ducttape

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4 of them apparently have, including Kentucky, Tenn, W Virginia and Michigan. Schedule V.

fwiw, I stop gabapentin all the time.
 

bedrock

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Doubt it will affect my practice. If already on opioid, taking gaba concurrently is much less of a risk than a benzo or soma.

And if they are able to take a lower opioid dose due to gaba use, then it's far better than raising their opioid dose.
 
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Ferrismonk

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I'm in Michigan. Seeing gabapentin and lyrica on the PDMP is eye opening. I've seen multiple people getting multiple scripts from different docs. Gabapentin is the cheaper alternative when people can't get opiates to space out.

I don't go above 300 TID, and often remove it if ineffective. People also frequently choose to wean off when they learn it causes weight gain.

World is weird. When I was in fellowship (not that long ago really), we made sure everyone was on a muscle relaxer if spasms, NSAID if any arthritis, gabapentin if any neuropathy, TCA if trouble sleeping and neuropathy. We insisted people take all these scripts due to opiate sparing effects. Now, we wean off everything we can. Simple clean, low-dose opiate alone (or no opiates) is the new standard.
 

painfree23

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Doubt it will affect my practice. If already on opioid, taking gaba concurrently is much less of a risk than a benzo or soma.

And if they are able to take a lower opioid dose due to gaba use, then it's far better than raising their opioid dose.
10000% agree but do you think the lawyers would agree?
 

gaseous_clay

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I'm in Michigan. Seeing gabapentin and lyrica on the PDMP is eye opening. I've seen multiple people getting multiple scripts from different docs. Gabapentin is the cheaper alternative when people can't get opiates to space out.

I don't go above 300 TID, and often remove it if ineffective. People also frequently choose to wean off when they learn it causes weight gain.

World is weird. When I was in fellowship (not that long ago really), we made sure everyone was on a muscle relaxer if spasms, NSAID if any arthritis, gabapentin if any neuropathy, TCA if trouble sleeping and neuropathy. We insisted people take all these scripts due to opiate sparing effects. Now, we wean off everything we can. Simple clean, low-dose opiate alone (or no opiates) is the new standard.

This is all starting to get ridiculous. NSAIDs, Lyrica, gabapentin, TCAs, SSRIs/SNRIs, and obviously, opioids all have adverse effects. Interventional procedures and surgery have also demonstrated poor long term efficacy. Other than hoping patients will participate in PT, CBT, biofeedback, diet and lifestyle modifications, etc., which hardly happens in real life or simply isn’t feasible, what else can this specialty continue to offer? And please don’t say THC/CBD.
 
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Ducttape

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Other than hoping patients will participate in PT, CBT, biofeedback, diet and lifestyle modifications, etc.

that's it.
 

Ligament

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This is all starting to get ridiculous. NSAIDs, Lyrica, gabapentin, TCAs, SSRIs/SNRIs, and obviously, opioids all have adverse effects. Interventional procedures and surgery have also demonstrated poor long term efficacy. Other than hoping patients will participate in PT, CBT, biofeedback, diet and lifestyle modifications, etc., which hardly happens in real life or simply isn’t feasible, what else can this specialty continue to offer? And please don’t say THC/CBD.

*IV* CBD?

All my patients love their CBD and swear it cures their dog's arthritis. They are so proud of their CBD.
 
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