FDA Releases Warning Regarding Gabapentin and Pregabalin

FDA Releases Warning Regarding Gabapentin and Pregabalin
Released: 12/23/2019   By: Heidi Dufrene, PharmD

The FDA recently released a warning for the medications, gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR).  The FDA warned that serious breathing difficulties may occur in patients using these medications who have respiratory risk factors. These risk factors include the use of opioids and other drugs that may depress the central nervous system (anti-anxiety medications, antidepressants, antihistamines). Patients who have certain medication conditions such as chronic obstructive pulmonary disease (COPD) may also be at an increased risk due to reduced lung function. Elderly patients may also be at an increased risk for breathing issues while using these medications.

Gabapentin and pregabalin are FDA-approved to treat several conditions, including seizures and neuropathic pain. These medications, often called gabapentinoids, are often prescribed in the realm of workers’ compensation. The FDA states that both the prescribed medicinal use and misuse and abuse have been growing for these drugs. The combination of gabapentin or pregabalin with other central nervous system depressants has also increased. The FDA does state that there is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentin or pregabalin alone and they will continue to monitor these medications.

The FDA is requiring new warnings regarding the risk of respiratory depression be added to current prescribing information for these medications. The FDA is also requiring drug manufacturers to conduct clinical trials to further evaluate the abuse potential of these gabapentinoids, especially in combination with opioids since misuse and abuse of these two drug classes is increasing.

Carlisle Medical will continue to monitor for future updates regarding these medications. The link to the FDA communication can be found below.