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.
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. Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Take oxcarbazepine with a full glass of water. Shake theGive the oral liquid directly from the oral syringe, or mix the medicine with a small glass of water. After using the syringe, rinse it with water and allow it to air dry.
Do not stop taking the medication even if you feel better. It is important to take oxcarbazepine regularly to prevent seizures from recurring. Get your prescription refilled before you run out of medicine completely. Call your doctor promptly if this medicine does not seem to be working as well in preventing your seizures. Carry an ID card or wear a medical alert bracelet stating that you are taking oxcarbazepine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a seizure disorder.Seizures are often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.
Store oxcarbazepine at room temperature away from moisture and heat.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 the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Symptoms of an oxcarbazepine overdose are unknown.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.
Oxcarbazepine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not drink alcohol while taking oxcarbazepine. Alcohol may increase drowsiness caused by oxcarbazepine. It may also increase the risk of seizures.Related Learning Centers |
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