Gabapentin, Pregabalin, and Back Pain: FDA Safety Alert

People with radiating chronic spine pain may be prescribed gabapentin or pregabalin to treat their nerve-related neck, back and/or leg pain. If you’re taking either of these medications, please note: In December 2019, the U.S. Food and Drug Administration (FDA) released a safety alert that gabapentin (brand names: Neurontin, Gralise, Horizant) and pregabalin (brand names: Lyrica and Lyrica CR) may increase the risk for serious breathing problems if you’re also taking a central nervous system (CNS) depressant or have respiratory problems. CNS depressants are drugs that include tranquilizers and sedatives.

prescription bottle with warning labelsWhile all prescription and OTC drugs carry risk for side effects, the FDA has released a special safety alert specifically for gabapentin and pregabalin. Photo Source:

What Should I Know About this Drug Safety Alert?

After reviewing case reports and existing medical literature, observational studies, clinical trials, and animal studies, the FDA released a drug safety warning linking gabapentin and pregabalin to serious breathing problems.

It’s important to know that this safety alert is not for all users of gabapentin and pregabalin. This drug warning is for people taking gabapentin or pregabalin who also have respiratory risk factors that include:

  • Taking gabapentin or pregabalin with a central nerve system (CNS) depressant or opioid medication
  • Having an existing respiratory condition, such as chronic obstructive pulmonary disease (COPD)

The FDA also said that elderly users of these medications are at a higher risk of experiencing serious breathing problems.

CNS depressants are sometimes prescribed to treat insomnia, acute stress, anxiety, or muscle spasms. These medications work by slowing brain and nervous system activity. Central nervous system depressants include:

  • Benzodiazepines are tranquilizers, such as diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), triazolam (Halcion), estazolam (Prosom)
  • Non-benzodiazepine sedative hypnotics help induce sleep, such as zolpidem (Ambien), eszopiclone (Lunesta), zaleplon (Sonata)
  • Barbituates treat seizure or anxiety, such as mephobarbital (Mebaral), phenobarbital (Luminal), pentobarbital sodium (Nembutal)

Where Gabapentin and Pregabalin Fit in the Spine Pain Treatment Plan

The FDA has approved gabapentin and pregabalin for several conditions, from seizures and restless leg syndrome to diabetes and fibromyalgia. Although not specifically approved to treat chronic back and neck pain, your doctor may also prescribe these drugs if you have nerve-related spine pain.

Gabapentin and pregabalin, which are sometimes called gabapentinoids, belong to a class of prescription drugs called anticonvulsants, which is why they are often prescribed for seizure management. These medications also have neuropathic properties—that is, they treat nerve pain.

If you experience chronic nerve pain in your spine, it might feel like weakness, shooting pain, burning, and/or tingling throughout your back and neck. Sometimes pain radiates into an extremity, such as an arm or leg (eg, sciatica). Gabapentinoids can help ease those sensory symptoms in some people. Gabapentin may even be prescribed to treat nerve pain after spinal cord injury.

Respiratory Warning Signs People Should Understand

If you or a loved one take pregabalin or gabapentin, the FDA urges you to be aware of the following respiratory warning signs that warrant immediate medical attention:

  • Slowed, shallow breathing
  • Bluish skin (often on the lips or extremities)
  • Confusion-related symptoms: disorientation, dizziness, lightheadedness
  • Excessive fatigue or sleepiness
  • Change or lack of responsiveness (a person doesn’t react normally, answer to his or her name, or is unable to awake from sleep)

If you experience any of these symptoms, seek emergency medical attention (ie, don’t wait to see your personal doctor), as they may be life threatening.

The side effects above warrant urgent medical attention, but it’s important to also report to your doctor if you experience any of these more common, less urgent side effects of gabapentinoids: drowsiness, blurry vision, difficulty coordinating and concentrating, and swelling in your hands, legs, and feet.

What Can I Expect as a Result of this Safety Alert?

The FDA will require new warnings about the respiratory risks associated with gabapentin and pregabalin to be included on the prescription information provided with these drugs.

In its research evaluation, the FDA also discovered an increase in prescription rates for gabapentin and pregabalin. Because these drugs are often prescribed with an opioid drug—and because they also bear addiction and abuse potential on their own—the FDA is also requiring the manufacturers of these medications to conduct clinical trials that assess the abuse potential for gabapentin and pregabalin.

Note that the FDA does not currently schedule gabapentin as a controlled substance; however, pregabalin is a Schedule V controlled substance, meaning that although it has a lower risk of abuse, there is some risk for dependence.

Be Drug Smart: What You Should Do with this Information

Medications are an effective way to help manage your spine pain affecting your neck or back, but it’s important to recognize that all medicines bear the risks of side effects. In most cases, these side effects are minimal. You can do your part to reduce adverse medication affects by always taking a drug as prescribed and telling your doctor about all drugs, medicines, and supplements you’re taking to help prevent potentially serious interactions.

This FDA safety alert for gabapentin and pregabalin draws attention to potential breathing problems associated with these medications, which may be life threatening. If you take these drugs and experience respiratory problems or other concerning symptoms, seek immediate medical attention.

Updated on: 01/29/20
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