The FDA’s Unsettling Gabapentin Warning

In December, the U.S. Food and Drug Administration (FDA) issued a warning that Gabapentin could cause serious breathing problems and seizures when used in conjunction with some central nervous system depressants or in patients with certain health conditions. Monsour Law Firm’s personal injury attorneys frequently represent clients in dangerous drug cases, so we know firsthand the tragedy and pain involved when the prescription you trust to improve your health turns out to be detrimental. Here’s what you need to know about Gabapentin

Why Physicians Prescribe Gabapentin

Gabapentin is primarily prescribed for pain relief. If, for example, you’ve experienced nerve pain from shingles or the herpes virus, your physician might have written you a Gabapentin prescription to treat that pain. Drug makers market Horizant as a choice for treating restless leg syndrome and Neurontin as an anti-epileptic medication. Some doctors also prescribe Gabapentin to treat conditions like migraines, anxiety related mental health issues and, since it’s a sedative, insomnia. An online listing of uses includes everything from alcohol withdrawal to chemotherapy-induced nausea.

It’s one of the most commonly prescribed painkillers, partly in response to the opioid epidemic. Physicians once doled out Codeine, Fentanyl, hydrocodone and Demerol for serious (and sometimes not so serious pain), but opioids are highly addictive. Gabapentin is non habit-forming and not designated as a controlled substance, so it seemed a safer alternative.

The problem is, Gabapentin doesn’t always work so well when it comes to pain relief. It’s supposed to change electrical activity in the brain and inhibit the way neurotransmitters send pain signals. When you’re dealing with nerve pain, it seems like that should do the trick. Some studies indicate it doesn’t always provide the pain relief promised, leaving those suffering to reach for an opioid after all. That’s when the risk of breathing problems and seizures skyrockets.

What Drugs Are Included In the Warning

In December 2019 the FDA ordered drug manufacturers to conduct more studies and clinical trials to clearly define Gabapentin’s risk to patients. They mandated trials should especially focus on Gabapentin in conjunction with opioids and the connection to breathing issues.

Gabapentin is marketed as Neurontin, Gabarone, Gralise, Horizant, Fanatrex and their generics. Pharmacists sell Pregablin as Lyrica, Lyrica CR and its generics.

Why the Problem Could be Bigger Than We Know

There were 49 case reports submitted to the FDA between 2012 and 2017 concerning respiratory problems and Gabapentin. Among those, 12 people died. The FDA also reviewed multiple human and animal trials that found Gabapentin or Pregablin alone and Pregablin or Gabapentin plus opioids can depress respiratory function.

That could be just the tip of the iceberg. The FDA requires drugmakers to report breathing problems and other negative reactions to medications, but doctors and patients have no such requirement.

What You Should Do Now

The FDA is requiring drug makers to put more information on drug labeling to warn about the dangers of using Gabapentin with opioids. If you take any of the medications on the list, now is the time to talk with your doctor or pharmacist. Make sure you’re not taking anything else that might interact with your prescription, and that Gabapentin is still the best choice for your treatment. And if you have any other questions about dangerous drugs, feel free to get in touch.