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 is fioricet ?

Fioricet contains a combination of acetaminophen, butalbital, and caffeine. Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Fioricet Chemical Structure
Fioricet Chemical Structure

Fioricet is used to treat tension headaches that are caused by muscle contractions.

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg

Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects mediated by a metabolite which acts at cannabinoid receptors, contrary to popular belief it is not an antiinflammatory at safe levels (it becomes toxic at doses above 1,000mg per dose and/or 3,000mg per day). Caffeine is thought to produce constriction of cerebral blood vessels and serves to counteract the sedative effect of butalbital.

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 5 to 7 hours.

Fioricet (butalbital/acetaminophen/caffeine) has been around forever and is used by many for the treatment of chronic migraine or tension headaches. It is a mixture of a barbiturate, Tylenol (acetaminophen) and caffeine.

Now, many formularies are no longer covering Fioricet capsules. For those of you who have relied on it for years, this (understandably) may make you nervous.

Well, it turns out it doesn’t really work that well—and there are much better options out there.

  • Fioricet and Fioricet with Codeine are not as effective for acute migraine as newer medications. There isn’t any evidence that shows that barbiturate-containing meds (the butalbital in Fioricet) help for migraine treatment. In fact, the use of Fioricet with Codeine often results in chronic migraine and a “medication overuse headache.”
  • NSAIDS. Start with these instead. There is good evidence that nonsteroidal anti-inflammatory drugs—ibuprofen, naproxen, and others—work well for the treatment of acute migraine.
  • Triptans. Imitrex (sumatriptan), Maxalt (rizatriptan), Relpax (eletriptan), and Frova (frovatriptan) are examples. Used alone or in combination with an NSAID, triptans work well for moderate to severe headaches that aren’t relieved by NSAIDs alone. Wondering which to choose? They generally work the same but you may notice fewer side effects with one over the other. Cost can also be an issue so you’ll want to pick a triptan that is covered by your insurance plan. It’s also a good idea to check GoodRx to see if the cash or discount price beats your co-pay.
  • Adding a nausea medication. For folks with moderate to severe migraine accompanied by nausea or vomiting, adding Reglan (metoclopramide) , Zofran (ondansetron) or Compazine (prochlorperazine) also helps.

Bottom line is . . . while your Fioricet capsules may no longer be covered, better options exist.

What is side effects of Generic Fioricet ?

Nausea, vomiting, abdominal pain, shaking (tremor), shortness of breath, increased urination, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Stop using Fioricet and call your doctor at once if you have:

  • confusion, seizure (convulsions);
  • shortness of breath;
  • a light-headed feeling, like you might pass out; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

What Are the Possible Side-Effects of Fioricet?

Like any medication, Fioricet can cause side-effects. People who misuse Fioricet or use it compulsively are at greater risk for experiencing the worst side-effects of the medication.

The possible side-effects of Fioricet are:

      • Anxiety
      • Dizziness
      • Drowsiness
      • Feelings of being intoxicated
      • Lightheadedness
      • Nausea and vomiting
      • Shaking and tremors
      • Shortness of breath
      • Stomach pain
      • Trouble sleeping

In some cases, a person who takes Fioricet may develop an allergic reaction to the drug. The symptoms of an allergic reaction are trouble breathing, itching, rashes, intense dizziness, and swelling in the face, throat, and tongue.

What are the Symptoms of a Fioricet Overdose?

While butalbital is the addictive ingredient in Fioricet, acetaminophen is the ingredient which is liable to cause an overdose. Unfortunately, people who misuse Fioricet as a recreational drug or as a way to suppress withdrawal are most likely to suffer an overdose.

When a person overdoses on Fioricet, the acetaminophen will damage their liver. In severe cases, an overdose can even provoke fatal liver failure. For this reason, it is dangerous to take Fioricet together with another medication which contains acetaminophen because it increases the risk of overdose and death. Furthermore, drinking alcohol while taking Fioricet may also inflict liver damage.

A Fioricet overdose is a medical emergency, so it’s important to know the symptoms. An overdose on Fioricet and all other forms of liver failure cause jaundice, the yellowing of the skin and eyes. Other symptoms of an overdose include:

    • Confusion
    • Convulsions and seizures
    • Fainting
    • Irregular heartbeat
    • Lack of appetite
    • Nausea and vomiting
    • Restlessness
    • Stomach pain
    • Sweating
    • Tremors

endometriosis pain relief?

endometriosis pain relief?
Just curious if anyone knows a good pain relief for endometriosis. I refuse to go on lupron or any other hormonal treatments because I have bad side effects with some of them. Not only that me and my husband are going to try to concieve when he gets back from his tour of Korea early next month. Can someone give me some advice? The doctors here on post dont really care to much for their patients…They just want them in and out. Please help…The pain gets really really bad

Best answer:

Answer by tazzer
vicodin…..that was the only thing that helped me….and it won’t hurt when you try to conceive…i had to take it while i was pregnant…either that or tylenol 3 ob/gyn prescribed it for me…good luck

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Advice on gallstone pain relief?

Advice on gallstone pain relief?
I just had one of my daily gallstone attacks and my painkillers no longer work 🙁 I’m still in pain but it dies down a tiny bit more every half hour. I’m 25 weeks pregnant so my pain relief is limited and I don’t eat fatty foods anymore, I follow a diet sheet the doctor made with me and the pains r still sever, anyone got advice on pain relief? I already been told my pancreas is really swollen with these attacks so doesn’t help matters but haven’t been told much on pain relief 🙁

Best answer:

Answer by Debbie
Your gallstone is triggering a pancreatitis attack. I know that you are pregnant and you can’t avoid foods for long periods of time, but you need to do your best to limit food intake until the pain subsides. The pain won’t stop until the pancreas calms down. Believe me when I say that it is imperative for your pancreas to calm down or there could be some permanent damage as a result. You need to follow a fat free diet. Avoid stimulants like sugar, caffeine, chocolate. Avoid gassy foods like beans and high fiber pastas or breads. Eat cooked veggies, but avoid salad. Bananas are really hard on the digestive tract for several reasons, so avoid those. Avoid really acidic food such as oranges, lemons, limes, tomatoes, etc. Acid, fiber, stimulants, fat, and protein, all stimulate the pancreas and make it worse. Start off by drinking fat free broth, water, sugar free popsicles, sugar free jello. even though you can tolerate more than that eat low fiber lowfat bread, ripe blueberries, melons, cooked veggies, fat free cereals like rice krispies, and fat free milk. Generally increase as tolerated. I hope you feel better soon!

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