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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[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. |
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Lamotrigine may cause serious rashes that may need to be treated in a hospital or cause permanent disability or death. Tell your doctor if you are taking valproic acid (Depakene) or divalproex (Depakote), because taking these medications with lamotrigine may increase your risk of developing a serious rash. Your doctor will start you on low dose of lamotrigine and gradually increase your dose, not more than once every 1-2 weeks. You may be more likely to develop a serious rash if you take a higher starting dose or increase your dose faster than your doctor tells you that you should. Be sure to take lamotrigine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Serious rashes usually develop during the first 2-8 weeks of treatment with lamotrigine, but can develop at any time during treatment. If you develop any of the following symptoms while you are taking lamotrigine, call your doctor immediately: rash; fever; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; hoarseness; difficulty breathing or swallowing; upset stomach; extreme tiredness; unusual bruising or bleeding; lack of energy; loss of appetite; pain in the upper right part of the stomach; yellowing of the skin or eyes; flu-like symptoms; pale skin; headache; dizziness; fast heartbeat; weakness;; shortness of breath; sore throat, fever, chills, and other signs of infection;dark red or cola-colored urine; muscle weakness or aching; or painful sores in your mouth or around your eyes. Talk to your doctor about the risks of taking lamotrigine or of giving lamotrigine to your child. Children who take lamotrigine are more likely to develop serious rashes than adults who take the medication. |
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Lamotrigine is used to treat certain types of seizures in patients who have epilepsy or Lennox-Gastaut syndrome (a disorder that causes seizures and often causes developmental delays). Lamotrigine is also used to increase the time between episodes of depression, mania (frenzied or abnormally excited mood), and other abnormal moods in patients with bipolar I disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Lamotrigine has not been shown to be effective when people experience the actual episodes of depression or mania, so other medications must be used to help people recover from these episodes. Lamotrigine is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Lamotrigine comes as a regular tablet and a chewable dispersible (can be chewed or dissolved in liquid) tablet to take by mouth. It is usually taken once or twice a day. It is sometimes taken once every other day at the beginning of treatment. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand.
There are other medications that have names similar to the brand name for lamotrigine. You should be sure that you receive lamotrigine and not one of the similar medications each time you fill your prescription. Be sure that the prescription your doctor gives you is clear and easy to read. Talk to your pharmacist to be sure that you are given lamotrigine. After you receive your medication, compare the tablets to the pictures in the manufacturer's patient information sheet. If you think you were given the wrong medication, talk to your pharmacist. Do not take any medication unless you are certain it is the medication that your doctor prescribed.
Swallow the regular tablets whole; do not split, chew, or crush them.
If you are taking the chewable dispersible tablets, you may swallow them whole, chew them, or dissolve them in liquid. If you chew the tablets, drink a small amount of water or diluted fruit juice afterward to wash down the medication. To dissolve the tablets in liquid, place 1 teaspoon of water or diluted fruit juice in a glass or on a spoon. Place the tablet in the liquid and wait 1 minute to allow it to dissolve. Then mix the liquid and drink all of it immediately.
If you were taking another medication to treat seizures and are switching to lamotrigine, your doctor will gradually decrease your dose of the other medication and gradually increase your dose of lamotrigine. Follow these directions carefully and ask your doctor or pharmacist if you have questions about how much of each medication you should take.
Lamotrigine may control your condition, but it will not cure it. Continue to take lamotrigine even if you feel well. Do not stop taking lamotrigine without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking lamotrigine, you may experience seizures. If you do stop taking lamotrigine for any reason, do not start taking it again without talking to your doctor.
Your doctor or pharmacist will give you the manufacturer's patient information sheet. Read it carefully before you begin taking lamotrigine and each time you refill your prescription. Ask your doctor or pharmacist if you have any questions.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before taking lamotrigine,
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Lamotrigine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms or those described in the IMPORTANT WARNING section, call your doctor immediately:
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to lamotrigine.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Last Revised -
07/01/2005
Last Reviewed -
04/01/2000
The MedMaster™ Patient Drug Information database provides information copyrighted by the American Society of Health-System Pharmacists, Inc., Bethesda, Maryland Copyright© 2008. All Rights Reserved.
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Page last updated: 17 April 2008 |