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Generic Name: topiramate

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A carbonic anhydrase inhibitor anticonvulsant - used for Seizure and Migraine

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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(toe PYRE a mate)

What is the most important information I should know about topiramate?

Seek emergency medical attention if you have a sudden change in vision and pain around or behind the eyes. These may be early signs of a serious side effect of topiramate. Do not stop taking topiramate without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking topiramate suddenly. You will need to use less and less before you stop the medication completely. Contact your doctor if your seizures get worse or you have them more often while taking topiramate.

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. Carry an ID card or wear a medical alert bracelet stating that you are taking topiramate, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication. Topiramate can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Avoid drinking alcohol. It can increase some of the side effects of topiramate, and can also increase the risk of a seizure.

Ketogenic or "ketosis" diets that are high in protein and low in carbohydrates can increase the risk of kidney stones. Avoid the use of such diets while you are taking topiramate.

What is topiramate?

Topiramate is a seizure medication, also called an anticonvulsant.

Topiramate is used alone or in combination with other medications to prevent seizures in adults and children who are at least 2 years old.

Topiramate is also used to prevent migraine headaches. Topiramate will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun.

Topiramate may also be used for other purposes not listed in this medication guide.

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