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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(toe PYRE a mate)

How should I take topiramate?

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. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Topiramate can be taken with or without food.

Take the medicine with a full glass of water.

The topiramate tablet should be swallowed whole. It has a bitter taste when chewed or broken.

To make the topiramate capsule easier to swallow, you may open the capsule and sprinkle the medicine into a spoonful of applesauce, custard, ice cream, oatmeal, pudding, or yogurt. Swallow this mixture right away without chewing. Do not save the mixture for later use.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using topiramate. You may need to stop using the medicine for a short time.

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. 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. Drink extra fluids each day while you are taking topiramate. This will lower your risk of having kidney stones or an electrolyte imbalance. Vomiting or diarrhea can lead to dehydration and cause an electrolyte imbalance. Call your doctor if you have ongoing vomiting or diarrhea while taking topiramate. Store topiramate at room temperature away from moisture and heat.

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.

What happens if I overdose?

Seek emergency medical treatment if you think you have used too much of this medicine.

Overdose symptoms may include drowsiness, dizziness, agitation or depression, blurred vision, problems with speech or balance, stomach pain, chest pain, fast or pounding heartbeats, feeling light-headed, fainting, and seizure (convulsions).

What should I avoid while taking topiramate?

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. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by topiramate. Tell your doctor if you regularly use any of these other medicines.

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.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink extra fluids in these situations.

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