Gabapentinoids are FDA-approved to treat a variety of conditions including partial seizures and nerve pain from spinal cord injury, shingles, and diabetes. Other approved uses include fibromyalgia and restless legs syndrome. Gabapentin was first approved in 1993 and pregabalin was first approved in 2004. They inhibit the alpha 2-delta subunit of voltage- gated calcium channel.
FDA has warned that serious breathing difficulties may occur in patients using gabapentin or pregabalin 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.
FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.
FDA 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.
FDA recommended patients and caregivers should seek medical attention immediately if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening.
Symptoms to watch for include:
Confusion or disorientation, Unusual dizziness or lightheadedness, Extreme sleepiness or lethargy, Slowed, shallow, or difficult breathing Unresponsiveness, Bluish-colored or tinted skin, especially on the lips, fingers, and toes.
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