Gabapentin Safety Limits

Gabapentin is approved by the Food and Drug Administration (FDA) for seizures and post-herpetic neuralgia, but has a wide variety of off-label uses including fibromyalgia, neuropathic pain, anxiety and insomnia. Between 1998 and 2013, gabapentin prescribing increased 55-fold and continues to rise, fueled by off-label use and the desire to use non-opioid alternatives for the treatment of pain.

There have been several deaths attributed to gabapentin in combination with benzodiazepines, opioids and muscle relaxers due to their combined CNS depressant effects. There has also been an increase in illicit use of gabapentin as the cutting agent in heroin. Whether abused alone or with other agents, gabapentin overdose can result in excessive altered mental status, nausea, vomiting, ataxia and coma. To reduce the risk of abuse and serious or fatal gabapentin-related events, CareOregon is adding new safety limits to this agent.

These new safety limits went into effect on May 1. While most patients may not be abusing gabapentin, these changes are necessary to promote safer use. There are three concerns the new gabapentin quantity limits will target:

  1. 1. Use above the FDA maximum dose either on single strength or multiple strengths.
  2. 2. Multiple strengths from multiple prescribers.
  3. 3. High quantities of low strengths.

Patients that are using multiple strengths or high quantities of gabapentin may be required to consolidate even if they are below the FDA maximum dose (such as using 3x300 mg capsules instead of 9x100 mg capsules). While CareOregon has taken steps to ensure appropriate utilization is not disrupted, some prescriptions that do not fall into the above categories may reject at the pharmacy. In these cases, providers will need to submit a prior authorization to continue gabapentin. 

Before submitting a PA, the following steps are recommended:

  1. 1. Evaluate if dose consolidation is possible.
  2. 2. Evaluate if the patient’s dose is above the FDA maximum (3,600 mg).
  3. 3. Evaluate if the patient may be getting gabapentin from another provider or from an old prescription.

Please call CareOregon if you are not sure why your patient’s prescription is rejecting. We will help identify the issue and how to resolve it.  As there are risks of withdrawal for patients on high dose gabapentin, please submit a taper plan with the PA request if applicable, so that we can allow a temporary supply of the medication to be processed. When tapering gabapentin, consider reducing the dose in a similar manner as when titrating up, typically reducing by 300 mg every day.

Patients and prescribers affected by this change were sent a letter with instructions on next steps. If you need additional time to submit a PA or taper plan, call us and we can allow a one-month supply of the medication until the necessary information is provided.