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FDA issues safety warning about serious breathing problems with gabapentin and pregabalin (Lyrica®)

December 17, 2019 · Clinical Connection team

On December 19, 2019, the U.S. Food and Drug Administration (FDA) issued a warning that patients with certain respiratory risk factors who are using gabapentin (Neurontin®, Gralise®, Horizant®) or pregabalin (Lyrica®, Lyrica® CR) may experience serious breathing difficulties.

These respiratory risk factors include patients using opioid analgesics or any other medication that may depress the central nervous system (CNS) and patients with pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD). Older adult patients are also at an increased risk for developing these serious breathing problems.

The FDA will require new warnings about the increased risk of respiratory depression be added to the prescribing information for gabapentin and pregabalin. Additionally, drug manufacturers will be required to conduct clinical trials to further study the abuse potential of gabapentin and pregabalin with opioid analgesics, as these medications are commonly prescribed together and may increase the risk of respiratory depression.

Impact on workers’ compensation
Gabapentinoids (e.g., gabapentin and pregabalin) are FDA-approved to treat multiple conditions including seizures and various nerve-related pain disorders. These medications may be prescribed off-label in workers’ comp for the treatment of neuropathic pain conditions. Gabapentinoids are commonly prescribed in combination with other CNS medications, including but not limited to opioid analgesics, benzodiazepines, skeletal muscle relaxants and antidepressants, to treat complex claims.

In our book of business, Neurontin (gabapentin capsules and tablets) and Lyrica (pregabalin capsules) are in the list of most frequently prescribed medications.

Impact on claimants
As with all medications, when prescribing gabapentinoids, the benefits and the risks for the patient should be carefully considered by the physician. In addition, when reviewing claims, it is important to evaluate the claimant’s prescription profile to determine if there are any significant drug-drug interactions, dosing concerns, particularly in older adults, if there is evidence of a respiratory condition and history of medication misuse.

In some cases, it may be necessary for medications to be tapered and discontinued due to the review. However, if these medications are medically necessary, it is recommended to prescribe the lowest effective dose of gabapentinoids and opioid analgesics for the shortest duration possible and closely monitor the claimant to help minimize any potential risk.

If a claimant currently taking gabapentin or pregabalin has questions related to this warning, they should talk to their healthcare professional.

To learn more about this FDA warning, click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.


Sources:

  1. U.S. Food and Drug Administration. FDA Drug Safety Communication. FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) when used with CNS depressants or in patients with lung problems. December 19, 2019. Available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin.

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