Neurontin, Gralise, Horizant (Gabapentin) and Lyrica, Lyrica CR (pregabalin): Serious Breathing Problems

TOPIC: Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Serious Breathing Problems

AUDIENCE: Patient, Neurology, Pain Management, Pulmonology, Pharmacy

BACKGROUND: Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome.

ISSUE:FDA is warning that serious breathing difficulties 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 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.

RECOMMENDATION: 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, 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 medicines and other substances such as alcohol.

Health care professionals should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other central nervous system depressant such as a benzodiazepine.

For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

What Should you Know Before you Buy Gabapentin Online

Gabapentin (Generic Neurontin ) was developed to treat epilepsy, but it is now used to treat various forms of chronic pain. It works by reducing the number of signals sent through the nerves. If the signals are reduced then the pain will be reduced. Research has shown that Gabapentin can help in treating various types of nerve pain.

Some Research Team performed searches to look for clinical trials where gabapentin was used to treat neuropathic pain or fibromyalgia. They found that 5633 participants had been involved in 37 studies of reasonable quality.  They tested gabapentin against placebo for four weeks or more.  Studies lasting only one or two weeks are unhelpful when pain can last for years.

Neuropathic pain is pain coming from damaged nerves. It differs from pain messages carried along healthy nerves from damaged tissue (a fall, cut, or arthritic knee). Neuropathic pain is treated by different medicines than pain from damaged tissue.

Medicines like paracetamol or ibuprofen are not effective in neuropathic pain, while medicines that are sometimes used to treat depression or epilepsy can be very effective in some people with neuropathic pain.  Our understanding of fibromyalgia (a condition of persistent, widespread pain and tenderness, sleep problems, and fatigue) is poor, but fibromyalgia can respond to the same medicines as neuropathic pain.

Gabapentin is helpful for some people with chronic neuropathic pain or fibromyalgia. Gabapentin comes as a capsule, tablet, or solution. You take it by mouth. Gabapentin is available as the brand-name drugs Neurontin, Gralise, and Horizant.  It’s also available as a generic drug.

It is very important that your doctor check your progress at regular visits, especially in the first few months if you have epilepsy. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

These may be cause serious allergic reactions that may involve multiple organs, such as your liver or kidneys. Check with your doctor right away if you or your child have more than one of the following symptoms: fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin.

Gabapentin may cause vision changes, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these side effects are especially bothersome, check with your doctor.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, other medicines for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you or your child are using gabapentin.

Do not stop using gabapentin without checking with your doctor. Stopping the medicine suddenly may cause seizures. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

 

Is Gabapentin Considered a Painkiller?

Gabapentin is commonly used to treat some types of nerve pain but is classified as an anticonvulsant medicine, not as an opioid or painkiller.

Gabapentin was first approved in 1993 and is used to treat:

    • postherpetic neuralgia, a nerve pain caused by the shingles virus (herpes zoster),
    • restless legs syndrome (RLS), a painful movement disorder in the legs
    • partial seizures in adults and children at least 3 years old who have epilepsy

Gabapentin works by affecting chemicals and nerves in the body that are involved in the cause of seizures and in some types of nerve pain.

Gabapentin is not a federally-controlled drug substance and does not contain an opioid (narcotic) medication. However, gabapentin misuse and abuse has been reported, and it may be restricted in some states through their state drug-monitoring program. Gabapentin abuse can boost the high a person gets from opioid painkillers, muscle relaxants, and anxiety medications. This can be dangerous and potentially life-threatening.

In 2019, the FDA issued an alert that serious breathing problems have been reported with gabapentin and other related drugs, like Lyrica (pregabalin) in people at risk of slowed breathing.

    • This includes people who use opioid pain medicine or CNS depressants, people with chronic obstructive pulmonary disease (COPD, and the elderly.
    • These serious breathing problems may be fatal.
    • Read more about this serious FDA warning here.

Avoid or limit the use of alcohol (in beverages or medicines) with gabapentin as it can worsen drowsiness or dizziness. Ask you doctor about drinking alcohol while you are taking gabapentin.

What type of pain does gabapentin treat?

Gabapentin is approved by the FDA to treat:

Postherpetic neuralgia: nerve pain that can occur due to an outbreak of shingles. Shingles, also known as herpes zoster, occurs when the chicken pox virus deep-seated in your nerve activates again later in life and causes a serious skin rash. Not everyone gets postherpetic neuralgia from shingles, but it can be painful if you do. It causes a burning nerve pain that lasts for months, or even years, after the rash and blisters have cleared up.

Restless legs syndrome (RLS): an uncontrollable urge to move your legs around, often at night. This is usually due to leg discomfort. It may occur most often when you are sitting, laying down, or during bedtime. It can be disruptful to sleep and travel. It is thought RLS may occur due to an imbalance of the chemical dopamine in the brain.

Gabapentin has also been used off-label for the treatment of other types of neuropathic (nerve) pain like peripheral diabetic neuropathy, fibromyalgia and trigeminal neuralgia. “Off-label” uses of gabapentin are uses that have not been approved by the FDA and are not found in the package insert, but may have been accepted for use by healthcare providers based on clinical use.

How does gabapentin come?

There are several brand names of gabapentin including Gralise, Horizant, and Neurontin. Use only the brand and form of gabapentin your doctor has prescribed.

Gralise (gabapentin) is indicated for the management of postherpetic neuralgia only. It is not used for epilepsy. Gralise comes as a 300 and 600 milligram (mg) extended-release (ER) tablet and in a 30-day starter pack of 78 tablets. A generic option is not yet available.

Horizant (gabapentin enacarbil) is used in adults to treat either nerve pain due to postherpetic neuralgia (PHN) or restless legs syndrome (RLS). Horizont is also an extended-release 300 mg or 600 mg tablet and is not interchangeable with other gabapentin products. A generic option is not yet available.

Neurontin (gabapentin) is an immediate-release form used to treat seizures in adults and children who are at least 3 years old, in addition to nerve pain due to shingles. It comes as 100, 300, or 400 mg oral capsules; 600 mg and 800 mg oral tablets, and as a 250 mg per 5 mL oral solution. It is also available as a generic option.

Some brands are only used for certain conditions, and these products may not be interchangeable. Check your medicine each time you get a refill to make sure you have received the correct form.

Some of these medicines may be expensive. Ask your healthcare provider if you are able to use a generic form of gabapentin for your condition (this may not always be possible). Generic options could save you hundreds of dollars each month, or may be less expensive than your insurance copay.

Also, check with the manufacturer who may offer copay cards or patient assistance programs to lessen your overall costs, if you qualify. Be sure to check for online coupons, too, that can save you money on both generics and brands.

To learn more about gabapentin, join the Drugs.com gabapentin Support Group and Q&A Section where you can ask questions, share experiences and keep up with the latest news.

This is not all the information you need to know about gabapentin for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full gabapentin information here, and discuss this information and any questions you have with your doctor or other health care provider.