FDA Drug Safety Announcement for Medications Containing Gabapentin and Pregabalin
In December of 2019, the FDA issued a safety announcement about certain seizure and nerve pain medications. This communication included a warning for drugs with the active ingredients gabapentin and pregabalin.
Keep reading to find out what this means for you.
What is the safety concern?
People who take gabapentin or pregabalin may have serious breathing difficulties if they are already at risk for respiratory issues. Known as gabapentinoids, these medications can be dangerous for patients to take who have conditions such as COPD, or any condition that reduces lung function.
When combined with medications that depress the central nervous system, like opioids, the risk of respiratory depression increases. Respiratory depression is a disorder where a person’s breathing becomes slow and ineffective. Respiratory depression causes a buildup of carbon dioxide in the body, and the lack of oxygen can become life threatening if not treated.
The FDA has seen an increase in usage of gabapentinoids, as well as misuse and abuse of these drugs. But, there is less evidence that using gabapentinoids alone is dangerous.
What are the brand names of medications affected by this announcement?
Medications that contain gabapentin include:
Neurontin
Gralise
Horizant
Read more like this
Explore these related articles, suggested for readers like you.
Medications that contain pregabalin include:
Lyrica
Lyrica CR
What do gabapentinoids treat?
Gabapentinoids treat the following conditions:
Nerve pain
Seizures
Fibromyalgia
Restless legs syndrome
Who is at risk?
The following populations are most at risk:
The elderly
People with known breathing problems, like COPD
People on medications that can depress the central nervous system, like opioids, benzodiazepines, or antihistamines
What should patients or caregivers do?
If you or someone you care for experiences any symptoms of respiratory problems, seek immediate medical attention because these symptoms can be life-threatening.
The following are symptoms of respiratory problems:
Confusion or disorientation
Dizziness or lightheadedness
Extreme sleepiness or lack of energy
Slowed, shallow, or labored breathing
Bluish tinted skin on the lip, fingers, or toes
Unresponsiveness
What safety measures are being taken?
The FDA is requiring that new warnings be added to gabapentinoid prescribing information. They are also requiring drug manufacturers to conduct more clinical trials to evaluate the potential for abuse of these medications, especially when taken with opioids.
To learn more, read the FDA press release here.
Why trust our experts?
