Gabapentin Warnings: FDA Alert About Serious Breathing Risks

From Dr. Z - Carpal tunnel syndrome specialist

Neurontin

Gabapentin carries an FDA warning because it can cause dangerous breathing problems when taken with opioids or other medications that slow the central nervous system. Older adults and people with lung disease are at the highest risk. Never stop gabapentin suddenly, and always discuss medication changes with your healthcare provider.

Gabapentin is one of the most commonly prescribed nerve pain medications in the United States. While it is generally considered safe when used correctly, the U.S. Food and Drug Administration (FDA) has issued important safety warnings about its use.



The most serious concern is respiratory depression (dangerously slowed breathing) when gabapentin is combined with opioid pain medications or other drugs that suppress the central nervous system. Understanding these warnings can help you use the medication more safely.

What are the FDA warnings for gabapentin?

The FDA warns that gabapentin can cause serious breathing problems when taken with opioid pain medications or other drugs that slow the central nervous system. Older adults, people with lung disease, and patients with sleep apnea are at the greatest risk. The FDA also advises patients not to stop gabapentin suddenly without medical supervision because doing so may cause withdrawal symptoms or increase seizure risk.

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FDA Issues Serious Gabapentin Warnings


In December 2019, the FDA required stronger warning labels for gabapentin and pregabalin because of reports of serious breathing problems. The warning applies to these medications:

  • Gabapentin Neurontin®
  • Gralise®
  • Horizant®
  • Pregabalin Lyrica®
  • Lyrica CR®


Between 2012 and 2017, the FDA received more than 50 reports of serious breathing complications, including 12 deaths, involving gabapentinoid medications. Because adverse drug events are voluntarily reported by most healthcare providers and patients, the actual number of cases is likely higher.

Who Is Most at Risk?


The greatest danger occurs when gabapentin is taken together with medications that slow breathing.


High-risk combinations include:

  • Opioid pain medications
  • Sleeping pills
  • Anti-anxiety medications
  • Muscle relaxants
  • Alcohol
  • Other central nervous system depressants


Certain people are also more vulnerable, including:

  • Adults over age 65
  • People with COPD or other chronic lung diseases
  • Individuals with sleep apnea
  • Patients with existing breathing problems


Because gabapentin remains active in the body for several hours, combining it with other sedating medications can significantly increase the risk of respiratory depression.

gabapentin risks infographic

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Why Did the FDA Strengthen the Warning?


Gabapentin prescriptions increased dramatically as physicians reduced opioid prescribing during the opioid epidemic.


Although gabapentin itself is not classified as an opioid, it became a common alternative for treating chronic pain. As its use expanded, reports of misuse and dangerous interactions also increased.


FDA officials noted that combining gabapentinoids with opioids significantly raises the risk of respiratory depression and opioid overdose.


To better understand these risks, the FDA also required manufacturers to perform additional clinical studies examining the safety of gabapentin and pregabalin, particularly when used alongside opioid medications.

Important Safety Advice


If you take gabapentin, do not stop the medication abruptly unless instructed by your healthcare provider. Suddenly discontinuing gabapentin can cause withdrawal symptoms and may increase seizure risk in susceptible individuals.


Instead:

  • Tell your doctor about every medication you take.
  • Avoid combining gabapentin with opioids unless specifically directed.
  • Avoid excessive alcohol while taking gabapentin.
  • Seek immediate medical attention if you experience:
  • Slow or difficult breathing
  • Extreme drowsiness
  • Blue lips or fingertips
  • Difficulty waking up

FDA Safety Warning

Gabapentin can cause serious breathing problems when combined with opioids or other medications that suppress the central nervous system. Older adults and people with lung disease face the greatest risk.

Summary


The FDA strengthened its gabapentin warnings because combining the medication with opioids or other sedatives can lead to dangerous breathing problems. The risk is highest for older adults and people with respiratory disease.



If you take gabapentin, never change or stop your medication without first speaking with your healthcare provider. Understanding these warnings—and knowing when to seek medical attention—can help you use the medication safely.

About Dr. Maik Zannakis


Dr. Maik Zannakis is Medical Director of CarpalRx and a specialist in non-surgical treatment of nerve and soft-tissue disorders. He has authored more than 120 medical publications and has helped thousands of patients better understand hand and wrist conditions through evidence-based education. Read his full bio at CarpalRx.

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