BRIEF—FDA issues safety alert on gabapentin and pregabalin products

The US Food and Drug Administration is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, from Pfizer, Gralise, from Depomed, Horizant, from XenoPort) or pregabalin (Lyrica, Lyrica CR, both from Pfizer) who have respiratory risk factors.

These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function.

The elderly are also at higher risk.

The FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.

The agency has also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.