The U.S. Food and Drug Administration recently issued a warning that two drugs commonly prescribed to injured workers and those with painful disabilities can cause breathing problems when taken together with central nervous system depressants such as opioids.
On December 19, 2019, the FDA said serious breathing difficulties may occur in patients using Gabapentin or Pregabalin (also known as Neurontin and Gralise) who have respiratory risk factors. This includes the use of opioids, conditions such as chronic obstructive pulmonary disease, and the elderly. These warnings are based on a review of several sources of data, including case reports submitted to the FDA and published in the medical literature, observational studies, human trials, and animal studies.
Gabapentinoids are FDA-approved for treating seizures and nerve-related pain associated with fibromyalgia and shingles. Since its release, Gabapentin (Neurontin) has increasingly become one of the most frequently prescribed medications for injured workers.
According to Optum, “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.”
To address these issues, the FDA will now require new warnings regarding the increased risk of respiratory depression for Gabapentin and Pregabalin. Because the two drugs are commonly prescribed together, the FDA will also force drug manufacturers to run clinical trials to investigate and study the abuse potential of Gabapentin and Pregabalin with opioid analgesics.
