Latest MedWatch Safety Alert: Significant Concern for Workers’ Compensation

Shanea McKinney, PharmD
Clinical Account Executive

The U.S. Food and Drug Administration (FDA) recently released a MedWatch Safety Alert regarding serious concerns around the use of gabapentinoids and the risk of serious breathing problems for patients who have respiratory risk factors, as well as those utilizing opioids or any other medications that may depress the central nervous system; this class of medications includes Neurontin (gabapentin), Gralise, Horizant, Lyrica (pregabalin), and Lyrica CR.

This alert is especially important in the medical management of workers’ compensation claims as many injured employees are commonly prescribed gabapentin, pregabalin, and their branded alternatives (such as Neurontin or Lyrica) in combination with opioids, benzodiazepines, sedative hypnotics, and anti-psychotic agents in the treatment of work-related injuries, all of which can cause central nervous system depression. Moreover, the presumption that an injured worker is not at risk for serious breathing problems because the workplace injury is not accepted for an indication including an inhalation-related trauma, Chronic Obstructive Pulmonary Disease (COPD), or asthma would be a false premise. Many employees suffer from non-work related pulmonary or respiratory impairment related to conditions such as emphysema, due to advancing age, bronchitis, or certain cancers whose condition may be exacerbated by the co-administration with a gabapentinoid, potentially leading to a hazardous work-related medical condition.

While the complete mechanism of the gabapentinoid class is not fully understood, the reduction of neurotransmitter release is accepted to be the primary source of effect. Neurontin or gabapentin, first approved by the FDA in 1993, and Lyrica or pregabalin, which was approved by the Agency in 2004, both have several approved indications including post-herpetic neuralgia, adjunct therapy to epilepsy with partial onset seizures, as well as neuropathic pain and fibromyalgia. Similarly, use of these medications may cause potentially serious adverse effects including depression, suicidality, dizziness, somnolence or sleepiness, and fatigue. When combined with opioids, benzodiazepines, sleep aids or other medications as well as non-medication agents such as alcohol which can induce CNS depressant effects, the dangers of co-administration with this medication class become much more evident. Likewise, gabapentinoids are becoming more commonly misused as mild tranquilizers producing euphoric effects similar to those produced by cannabis leading to increased sociability; known by the street names morontin and gabbies, an increasing trend for their use as party drugs with teens and young adults is growing in popularity.  While the abuse potential of this class of medications when used as monotherapy is minimal, there have been studies to demonstrate that patients have abused this therapeutic class for intoxication purposes.

Prescribers, healthcare professionals, and patients alike should all be able to recognize signs of overuse or abuse of gabapentin and pregabalin, especially in combination with other potentially dangerous medications as well as co-existing medical conditions. Potential adverse effects include dizziness, blurred or double vision, difficulty speaking, memory loss, confusion, increased drowsiness, as well as reduced or shallow breathing in patients. If an individual demonstrates these side effects while on therapy or with concomitant dangerous therapy, a health care provider should be contacted immediately. Equally as important, before initiating therapy with a gabapentinoid such as Neurontin, Horizant, Gralise (gabapentin) Lyrica, Lyrica CR (pregabalin), a health care provider should evaluate the potential risks of initiating treatment with co-existing medical conditions or continuing concomitant therapy with other medications.

What Does This Mean To Claims Professionals?

  • Not all injured patients will be impacted by this new FDA safety warning.
  • However, in the presence of risk factors mentioned above, an injured workers’ prescriber may make dosage adjustments to the current treatment regimen that includes gabapentinoids.
  • Prescribers may also express frustration over the selection of an appropriate agent for the treatment of pain following this latest warning. Please be aware that prescribers may select alternative agents such as tri-cyclic anti-depressants such as amitriptyline, serotonin reuptake inhibitors such as fluoxetine, or serotonin-norepinephrine reuptake inhibitors or duloxetine to mitigate potentially dangerous respiratory effects. As with all medication therapies, treatment should begin at the lowest dose to produce the intended effect while balancing potential adverse reactions.

If you have questions or would like any additional information, please consult your myMatrixx pharmacist or the myMatrixx clinical team at Clinical@myMatrixx.com.