FDA Warning: Pain Medications Gabapentin and Pregabalin May Cause Serious Breathing Difficulties

As the opioid crisis has grown over the past few decades, health care providers have been encouraged to rely more heavily on non-opioid treatments for chronic pain. While many options exist — including non-drug ones like exercise and cognitive behavioral therapy (CBT) — medications that were initially designed to treat seizures (called anticonvulsants) have become more widely used to treat certain types of chronic pain, such as fibromyalgia.

Although these drugs, which include gabapentin (Neurontin) and pregabalin (Lyrica), are still believed to be far safer than opioids for long-term use, the U.S. Food and Drug Administration (FDA) is now warning that they may cause “respiratory depression.” That means your breathing could become so slow and shallow that you end up with too much carbon dioxide in your blood and not enough oxygen. It’s a problem that has the potential to be fatal.

The FDA is now requiring manufacturers of these drugs to add a statement about the risk of respiratory depression to the prescribing information that patients receive with their prescription. They are also requiring the manufacturers to conduct research to determine whether these anticonvulsants are frequently abused/misused and whether inappropriate use increases the likelihood of respiratory side effects.

The FDA made these decisions after reviewing reports of adverse events. They also reviewed two randomized trials and three observational studies and found that pregabalin can suppress breathing and that gabapentin increases “pauses in breathing during sleep.”

While this news is certainly worth taking seriously, you should know that relatively few adverse events have actually been reported to the FDA, and those that occurred impacted people who already had known respiratory issues.

“Reports submitted to FDA and data from the medical literature show that serious breathing difficulties can occur when gabapentinoids are taken by patients with pre-existing respiratory risk factors. Among 49 case reports submitted to FDA over the five-year period from 2012 to 2017, 12 people died from respiratory depression with gabapentinoids, all of whom had at least one risk factor,” the agency wrote.

For comparison, 46 people die every single day after overdosing on a prescription opioid, according to the U.S. Centers for Disease Control and Prevention (CDC).

If you’re currently taking an anticonvulsant for pain relief but are mostly healthy, this news doesn’t  necessarily mean you need to stop — though it may be wise to check in with your health care provider to ensure that you’re taking the lowest effective dose.

The people who are at the greatest risk of respiratory issues on these medications are those who are elderly, have underlying respiratory problems, and those who simultaneously use opioids or other drugs that depress the central nervous system (such as anti-anxiety drugs in the benzodiazepine class).

According to the FDA, “There is less evidence supporting the risk of serious breathing difficulties with gabapentinoids alone in otherwise healthy individuals, and we will continue to monitor this population for additional evidence.”

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