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SaveGeneric Name: pregabalin
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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- Interactions
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.
Get emergency medical help if you have any of these
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:
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muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired);
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easy bruising or bleeding; or
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swelling in your hands or feet, rapid weight gain.
Less serious side effects may include:
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dizziness or drowsiness, anxiety;
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blurred vision;
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loss of balance or coordination;
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problems with memory or concentration;
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dry mouth;
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skin rash or itching;
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constipation, stomach pain;
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increased appetite; or
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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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