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):
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.
Before taking topiramate, tell your doctor if you are taking any of the following medicines:
amitriptyline (Elavil, Etrafon);
atropine (Donnatal, and others);
benztropine (Cogentin);
glycopyrrolate (Robinul);
hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic);
methscopolamine (Pamine) or scopolamine (Transderm-Scop);
risperidone (Risperdal);
bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
diabetes medicine you take by mouth, such as pioglitazone (Actos) or metformin (Actoplus Met, Avandamet, Glucophage, Fortamet);
glaucoma medications such as acetazolamide (Diamox), methazolamide (Neptazane), or dichlorphenamide (Daranide);
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), propantheline (Pro-Banthine); or
other seizure medications such as carbamazepine (Carbatrol, Tegretol), lamotrigine (Lamictal), phenytoin (Dilantin), or valproic acid (Depakote, Depakene).
This list is not complete and there may be other drugs that can interact with topiramate. 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.
Stop taking topiramate and call your doctor at once if you have any of these serious side effects:
sudden vision loss, pain around or behind your eyes;
dry mouth, increased thirst, confusion, drowsiness, decreased sweating, increased body temperature, and hot, dry skin,
nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions); or
severe pain in your side or lower back, painful or difficult urination.
Less serious side effects may include:
slowed thinking, memory problems, trouble concentrating;
problems with speech or balance;
numbness or tingling;
sleep problems (insomnia);
tired feeling;
headache, dizziness; or
loss of appetite, weight loss.
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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