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 pregabalin?
Pregabalin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system. Pregabalin is used to control seizures and to treat fibromyalgia. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) or herpes zoster (post-herpetic neuralgia). Pregabalin may also be used for other purposes not listed in this medication guide.

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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.

Lyrica 100MG Capsules PFIZER U.S.30/$73.49 or 90/$194.22
Lyrica 150MG Capsules PFIZER U.S.30/$73.49 or 90/$194.22
Lyrica 200MG Capsules PFIZER U.S.30/$73.49 or 90/$194.22
Lyrica 225MG Capsules PFIZER U.S.30/$73.49 or 90/$194.22
Lyrica 25MG Capsules PFIZER U.S.30/$72.44 or 90/$195.26
Lyrica 300MG Capsules PFIZER U.S.30/$73.49 or 90/$197.69
Lyrica 50MG Capsules PFIZER U.S.30/$73.49 or 90/$195.26
Lyrica 75MG Capsules PFIZER U.S.30/$72.44 or 90/$193.19

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What are the possible side effects of pregabalin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; 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:

  • muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired);

  • easy bruising or bleeding; or

  • swelling in your hands or feet, rapid weight gain.

Less serious side effects may include:

  • dizziness or drowsiness, anxiety;

  • blurred vision;

  • loss of balance or coordination;

  • problems with memory or concentration;

  • dry mouth;

  • skin rash or itching;

  • constipation, stomach pain;

  • increased appetite; or

  • joint or muscle pain.

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 pregabalin?
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. Take this medicine with a full glass of water. You may take pregabalin with or without food. Do not change your dose of pregabalin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition. If you are taking pregabalin to prevent seizures, keep taking it even if you feel fine. You may have an increase in seizures if you stop taking pregabalin. Follow your doctor's instructions.

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What is the most important information I should know about pregabalin?
You may have thoughts about suicide while taking this medication. 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. If you are taking pregabalin to prevent seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking pregabalin. Follow your doctor's instructions.

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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 pregabalin?
There may be other drugs that can interact with pregabalin. 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?

Pregabalin has been assigned to pregnancy category C by the FDA. Animal studies have revealed increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity including lethality, growth retardation, and both nervous and reproduction system functional impairment. Animal studies have reported that pregabalin crosses the placenta and have shown an increased risk in male-mediated teratogenicity. There are no controlled data in human pregnancy. Pregabalin should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Men being treated with pregabalin should be informed of the potential risk of male-mediated teratogenicity. Animal studies have reported increased incidences of specific skull alterations attributed to abnormally advanced ossification, retarded ossification, increased incidences of skeletal malformations, decreased fetal body weights, and visceral variations. When offspring were tested as adults, neurobehavioral abnormalities and reproductive impairment were observed.

There are no data on the excretion of pregabalin into human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for pregabalin in animal studies, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Animal studies have reported pregabalin to be present in milk.

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Who should NOT use this medication?

  • Hypersensitivity to pregabalin or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical treatment if you think you have used too much of this medicine. Symptoms of a pregabalin overdose are not known.

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What should I discuss with my healthcare provider before taking pregabalin?
You should not use this medication if you are allergic to pregabalin. Before using pregabalin, tell your doctor if you are allergic to any drugs, or if you have: congestive heart failure; diabetes; or kidney disease. If you have any of these conditions, you may need a dose adjustment or special tests to safely take pregabalin. 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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