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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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pregabalin
(pre GAB a lin)

What is this medicine?
PREGABALIN (pre GAB a lin) is used to treat nerve pain from diabetes, shingles, and fibromyalgia. It is also used to control seizures in epilepsy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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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. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Lyrica 100MG Capsules PFIZER U.S.30/$80.1 or 90/$211.71
Lyrica 150MG Capsules PFIZER U.S.30/$82.83 or 90/$228.86
Lyrica 200MG Capsules PFIZER U.S.30/$80.1 or 90/$211.71
Lyrica 225MG Capsules PFIZER U.S.30/$80.1 or 90/$211.71
Lyrica 25MG Capsules PFIZER U.S.30/$78.95 or 90/$212.84
Lyrica 300MG Capsules PFIZER U.S.30/$80.1 or 90/$215.49
Lyrica 50MG Capsules PFIZER U.S.30/$80.1 or 90/$212.84
Lyrica 75MG Capsules PFIZER U.S.30/$78.95 or 90/$210.57

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • anxiety, confusion
  • breathing problems
  • changes in vision
  • chest pain
  • jerking or unusual movements of any part of your body
  • loss of memory
  • muscle pain, tenderness, or weakness
  • tremors
  • unusual bruising or bleeding
  • worsening of mood, thoughts or actions of suicide or dying

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation or diarrhea
  • dry mouth
  • headache
  • insomnia or difficulty sleeping
  • nausea
  • weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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What may interact with this medicine?

  • medicines for diabetes, like pioglitazone or rosiglitazone
  • medicines used to help you sleep or relax like lorazepam, alprazolam, or diazepam
  • prescription pain medicines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Hypersensitivity to pregabalin or any ingredient in the formulation.

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What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. You may want to keep a personal record at home of how you feel your condition is responding to treatment. Share this information with your doctor or health care professional at each visit.

You should contact your doctor or health care professional if your seizures get worse or if you have any new types of seizures. Do not stop taking this medicine or any of your seizure medicines unless instructed by your doctor or health care professional. Stopping your medicine suddenly can increase your seizures or their severity.

Wear a medical identification bracelet or chain if you are taking this medicine for seizures, and carry a card that lists all your medications.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

If you have a heart condition, like congestive heart failure, and notice that you are retaining water and have swelling in your hands or feet, contact your health care provider immediately.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • bleeding problems
  • heart disease, including heart failure
  • history of alcohol or drug abuse
  • kidney disease
  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
  • an unusual or allergic reaction to pregabalin, gabapentin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant or trying to conceive with your partner
  • breast-feeding

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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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