FDA Safety Communication for Gabapentin and Pregabalin

December 19, 2019

The U.S. FDA has issued a warning that serious breathing difficulties may occur in patients who have respiratory risk factors and use the medications gabapentin or pregabalin. Risk factors include advanced age, respiratory diseases such as chronic obstructive pulmonary disease (COPD) that reduce lung function, and concomitant use with central nervous system (CNS) depressants such as antidepressants, anxiolytics, and antihistamines.

Gabapentin and pregabalin, known collectively as gabapentinoids, are FDA-approved to treat a variety of conditions such as nerve pain, seizures, and restless leg syndrome. Gabapentin is available as a brand name medication (Neurontin®, Gralise®, Horizant®) and as a generic. Pregabalin is sold under the brand names Lyrica® and Lyrica® CR. Lyrica, but not Lyrica CR, became available as a generic in 2019.

To address the potential risks involved in the use of gabapentinoids, the FDA is requiring new warnings be added to the drugs’ prescribing information. The agency has also required manufacturers to conduct new clinical trials to further evaluate the drugs’ abuse potential. The misuse and abuse of gabapentinoids in combination with opioids has increased in recent years. The use of these classes of drugs together may raise the chances of serious respiratory difficulties.

Patients or their caregivers should seek immediate medical attention in the event of serious respiratory problems, as these can be life-threatening. Signs and symptoms include dizziness, shortness of breath, confusion, extreme lethargy, unresponsiveness, and bluish skin – especially on the lips, fingers, and toes. Healthcare professionals should prescribe gabapentinoids at the lowest possible dose. They should also carefully monitor elderly patients, patients who have underlying respiratory disease, and patients who also take a CNS depressant. Patients who meet these criteria should be advised of the risks and how to identify respiratory depression.

Further information regarding the warning can be found at the FDA’s website. Patients, caregivers, and healthcare providers are encouraged to report adverse events that may be related to the use of gabapentinoids to the FDA’s MedWatch program.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.


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