Drug Notebook

FDA Alerts

Special Alerts:

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

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gabapentin
(GA ba PEN tin)

What is gabapentin?
Gabapentin is an anti-epileptic medication, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain. Gabapentin is used alone or in combination with other medications to treat seizures caused by epilepsy in adults and children who are at least 12 years old. Gabapentin is also used with other medications to treat partial seizures in children who are 3 to 12 years old. Gabapentin is also used to treat nerve pain caused by herpes virus or shingles (herpes zoster).

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Gabapentin 100MG Capsules GREENSTONE90/$25.99 or 270/$64.96
Gabapentin 300MG Capsules GREENSTONE90/$59.99 or 270/$169.97
Gabapentin 400MG Capsules GREENSTONE90/$74.99 or 270/$209.98
Gabapentin 600MG Tablets IVAX PHARMACEUTICALS, INC.90/$92.99 or 270/$235.98
Gabapentin 800MG Tablets IVAX PHARMACEUTICALS, INC.90/$72.99 or 100/$79.97
Neurontin 100MG Capsules PFIZER U.S.100/$74.99 or 300/$209.97
Neurontin 250MG/5ML Solution PFIZER U.S.470/$136.58 or 1410/$362.23
Neurontin 300MG Capsules PFIZER U.S.30/$55.64 or 90/$163.76
Neurontin 400MG Capsules PFIZER U.S.30/$66.14 or 90/$187.93
Neurontin 600MG Tablets PFIZER U.S.90/$299.23 or 100/$331.76
Neurontin 800MG Tablets PFIZER U.S.90/$363.26 or 270/$1056.27

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What are the possible side effects of gabapentin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • increased seizures;

  • fever, chills, body aches, flu symptoms;

  • swelling of your ankles or feet;

  • confusion;

  • rapid back and forth movement of your eyes;

  • tremor; or

  • easy bruising.

Some side effects are more likely in children taking gabapentin. Contact your doctor if the child taking this medication has any of the following side effects:

  • changes in behavior;

  • memory problems;

  • trouble concentrating; or

  • acting restless, hostile, or aggressive.

Less serious side effects may include:

  • dizziness, drowsiness, weakness, tired feeling;

  • lack of coordination;

  • blurred vision;

  • nausea, vomiting, stomach pain, loss of appetite;

  • diarrhea, constipation;

  • dry mouth;

  • runny or stuffy nose, sore throat;

  • headache;

  • sleep problems (insomnia), unusual dreams; or

  • acne, mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take gabapentin?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Gabapentin can be taken with or without food. If you break a tablet and take one half of it, take the other half at your next dose. Any tablet that has been broken should be used as soon as possible or within a few days. Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

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What is the most important information I should know about gabapentin?
You should not use this medication if you are allergic to gabapentin. Before taking gabapentin, tell your doctor if you have kidney, liver, or heart disease. You may have thoughts about suicide while taking gabapentin. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect gabapentin?
The following drugs can interact with gabapentin. Tell your doctor if you are using any of these: hydrocodone (Lortab, Vicodin, Vicoprofen, and others); morphine (Kadian, MS Contin, Oramorph, and others); or naproxen (Naprosyn, Aleve, Anaprox, and others). This list is not complete and there may be other drugs that can interact with gabapentin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Gabapentin has been assigned to pregnancy category C. Animal studies have revealed evidence of fetotoxicity involving delayed ossification in several bones of the skull, vertebrae, forelimbs and hindlimbs. Hydroureter and hydronephrosis have also been reported in animal studies. There are no controlled data in human pregnancy. Gabapentin should only be given in pregnancy when benefit outweighs risk.

Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.

There are no data on the excretion of gabapentin into human milk.

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Who should NOT use this medication?

  • Known hypersensitivity to gabapentin or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include blurred vision, drowsiness, weakness, slurred speech, or diarrhea.

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What should I discuss with my healthcare provider before taking gabapentin?
You should not use this medication if you are allergic to gabapentin. Before taking gabapentin, tell your doctor if you are allergic to any drugs, or if you have: kidney disease; liver disease; or heart disease. If you have any of these conditions, you may need a dose adjustment or special tests to safely take gabapentin. You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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