FDA warns Gabapentin, Pregabalin may cause serious breathing problems

U.S. health regulators are warning that popular nervous system medications can cause dangerous breathing problems when combined with opioids and certain other drugs.

FDA Announcement

The U.S. Food and Drug Administration (FDA) has release a warning related to the use of gabapentin and pregablin. In the warning they said that “serious breathing problems may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) 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 (COPD) that reduce lung function. The elderly are also at higher risk. Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome.

FDA evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse.

Gabapentinoids are often being combined with CNS depressants, which increases the risk of respiratory depression. CNS depressants include opioids, anti-anxiety medicines, antidepressants, and antihistamines. There is less evidence supporting the risk of serious breathing problems in healthy individuals taking gabapentinoids alone.

FDA will continue to monitor these medicines as part of their routine monitoring of all FDA-approved drugs.

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What are gabapentinoids and how can they help me?

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. Gabapentin is marketed under the brand names Neurontin and Gralise, and also as generics. Gabapentin enacarbil is marketed under the brand name Horizant. Pregabalin is marketed under the brand names Lyrica and Lyrica CR, and also as generics. Pregabalin is a Schedule V controlled substance, which means it has a lower potential for abuse among the drugs scheduled by the Drug Enforcement Administration (DEA), but may lead to some physical or psychological dependence.

What should patients and caregivers do in case of breathing problems?

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 light headedness
• Extreme sleepiness or lethargy
• Slowed, shallow, or difficult breathing
• Unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up
• Bluish-colored or tinted skin, especially on the lips, fingers, and toes

Always inform your health care professional about all the drugs you are taking, including prescription and over-the-counter (OTC) medicines and other substances such as alcohol.

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What is my risk?

All medicines have side effects even when used correctly as prescribed, but in general the benefits of taking a medicine outweigh these risks. It is important to know that people respond differently to all medicines depending on their health, other medicines they are taking, the diseases they have, genetics, and many other factors. As a result, we cannot determine the likelihood that someone will experience these side effects when taking gabapentinoids. Your personal health care professional knows you best, so always tell them about all other medicines you are taking and if you experience any side effects while taking your medicines. Related: 9 side effects of fibromyalgia drugs you are not familiar with

How do I report side effects from gabapentinoids?

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving gabapentin, pregabalin, or other medicines to the FDA MedWatch program, using the information at the bottom of the page.

Facts about Gabapentinoids

• > Gabapentinoids include gabapentin and pregabalin. They are FDA-approved to treat a variety of conditions including partial seizures; pain from damaged nerves that follows spinal cord injury, healing of shingles, or diabetes; fibromyalgia; and moderate to severe primary restless legs syndrome.
• > Gabapentin is marketed under the brand names Neurontin and Gralise, and as generics. Gabapentin enacarbil is a prodrug of gabapentin marketed under the brand name Horizant.

>> Gabapentin is not scheduled by the Drug Enforcement Administration (DEA) as a controlled substance. A human abuse liability evaluation was not conducted when gabapentin was developed in the 1980s and early 1990s.

>> Gabapentin is available as a tablet, capsule, solution, and extended-release tablet.

• > Pregabalin is marketed under the brand names Lyrica and Lyrica CR, and as generics.

>> Pregabalin is a Schedule V controlled substance, which means that among the drugs scheduled by the DEA because of their abuse potential, it has a lower potential for abuse but may lead to some physical or psychological dependence.

>> Pregabalin is available as a capsule, solution, and extended-release tablet.

• > Common side effects of gabapentinoids include drowsiness, dizziness, blurry or double vision, difficulty with coordination and concentration, and swelling of the hands, legs, and feet.

Additional Information for Patients and Caregivers

• > FDA is warning that serious breathing problems may occur when gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) is taken with other medicines that depress the central nervous system (CNS) such as opioids, in those patients who have underlying respiratory problems, or in the elderly. There is less evidence supporting the risk of serious breathing problems with gabapentinoids alone in otherwise healthy individuals, and we will continue to monitor this population for additional evidence.
• > Respiratory problems can be life-threatening, so seek medical attention immediately if you or someone you are caring for experiences the following symptoms:

>> Confusion or disorientation

>> Unusual dizziness or lightheadedness

>> Extreme sleepiness

>> Slowed, shallow, or difficult breathing

>> Unresponsiveness, which means the person doesn’t answer or react normally or you can’t wake them up

>> Bluish-colored or tinted skin, especially on the lips, fingers, and toes

• > Always take gabapentinoids as prescribed. Do not take more of the medicine or take it more often than prescribed because doing so can cause serious problems or death.
• > Always tell all your health care professionals about all the medicines you are taking, including prescription and over-the-counter (OTC) medicines. It is helpful to keep a list of all your current medicines in your wallet or another location where it is easily retrieved. You can fill out and print a copy of My Medicine Record.
• > Read the patient Medication Guide every time you receive a prescription for a gabapentinoid. The Medication Guide will be updated with new or other important information about your medicine. The Medication Guide explains the important things that you need to know. These include the side effects, what the medicine is used for, interactions with other medicines, how to take and store it properly, and other things to watch out for when you are taking the medicine.
• > Talk to your health care professional if you have any questions or concerns.
• > To help FDA track safety issues with medicines, report side effects from gabapentin, pregabalin, or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

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Source: US Food and Drugs Administration, FDA. Read full report here