FDA issued the following warning on 12/19/2019, and requires this information to be included in the package insert of this medication class:
Combination of Gabapentinoids with CNS depressants in patients with “respiratory risk factors” can increase the risk of serious breathing difficulties.
- Gabapentinoids: includes Gabapentin and Pregabalin.
- CNS Depressants: includes opioids, anti-anxiety medicines (benzodiazepines), sedating antidepressant, sedating antipsychotic and antihistamine.
High Risk Patients:
- Patients with underlying respiratory disease
- elderly patients
- patients with renal impairment and patients undergoing hemodialysis
- Confusion or disorientation
- Unusual dizziness or lightheadedness
- Extreme sleepiness or lethargy
- Slowed, shallow, or difficult breathing
- Unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up
- Bluish-colored or tinted skin, especially on the lips, fingers, and toes.
When combining gabapentinoids with CNS depressants:
- Start gabapentinoids at the lowest dose.
- Titrate the dose carefully
- Monitor for symptoms of respiratory depression and sedation.
- Inform and educate patients and caregivers of these symptoms.
- Encourage patients to read the Medication Guide they receive with each gabapentinoid prescription, which explains the safety risks and provides other important information. (Medication Guide)
Management of Respiratory Depression:
- close observation
- supportive measures, and
- reduction or withdrawal of CNS depressants, including the gabapentinoid.
- Gabapentinoids should be tapered prior to discontinuation.
Dr. Harvinder Singh
Admin, Psychiatry Education Forum