Lamotrigine Side Effects
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Lamotrigine Safety Reports reported to FDA
Total Lamotrigine reports: 273.Lamotrigine FDA safety alerts: 2001 2006 2008 .
Reported deaths: 29 Reported hospitalizations: 91.
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Reported Lamotrigine Side Effects: convulsion, abortion spontaneous, pyrexia, coordination abnormal, stevens-johnson syndrome, intentional overdose, premature baby, rash erythematous, somnolence, nausea, vomiting.
Lamotrigine Usage.
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Lamotrigine Side Effects Report #5078386-7Health Professional from POLAND reported LAMOTRIGINE problem on July 23, 2006. Female patient was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: premature labour, premature separation of placenta. LAMOTRIGINE dosage: 200MG PER DAY. Patient recovered.
Lamotrigine Side Effects Report #5079160-8
LAMOTRIGINE problem was reported by a Health Professional from UNITED STATES on Aug 11, 2006. Female patient, 31 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: aura, caesarean section, oligohydramnios, premature labour. LAMOTRIGINE dosage: unknown. During the same period patient was treated with BETAMETHASONE. Patient recovered.
Lamotrigine Side Effects Report #5079161-X
Health Professional from UNITED STATES reported LAMOTRIGINE problem on Aug 10, 2006. Female patient, weighting 7.72 lb, was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: haemangioma of skin. LAMOTRIGINE dosage: 300MG TWICE PER DAY. Patient recovered.
Lamotrigine Side Effects Report #5081820-X
LAMOTRIGINE problem was reported by a Pharmacist from NETHERLANDS on Aug 08, 2006. Female patient was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: aphasia, dysgraphia. LAMOTRIGINE dosage: 100MG TWICE PER DAY. Patient recovered.
Lamotrigine Side Effects Report #5087545-9
Consumer or non-health professional from UNITED KINGDOM reported LAMOTRIGINE problem on Aug 18, 2006. Female patient, 42 years of age, was diagnosed with depression and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, hallucination, visual, headache, hyperacusis, nightmare, pain, sleep disorder. LAMOTRIGINE dosage: unknown. During the same period patient was treated with CITALOPRAM. Patient recovered.
Lamotrigine Side Effects Report #5087551-4
LAMOTRIGINE problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Aug 18, 2006. Female patient, 19 years of age, was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: erythema. LAMOTRIGINE dosage: unknown. Patient died.
Lamotrigine Side Effects Report #5091485-9
Consumer or non-health professional from UNITED KINGDOM reported LAMOTRIGINE problem on Aug 21, 2006. Female patient, 42 years of age, was diagnosed with depression and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: hallucination, visual, headache, hyperacusis, nightmare, sleep disorder. LAMOTRIGINE dosage: 75MG PER DAY. During the same period patient was treated with CITALOPRAM. Patient recovered.
Lamotrigine Side Effects Report #5094252-5
LAMOTRIGINE problem was reported by a Health Professional from UNITED STATES on Aug 30, 2006. Female patient, weighting 5.29 lb, was diagnosed with depression and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: ascites, caesarean section, cardiomyopathy, congenital teratoma, hydrops foetalis, pulmonary interstitial emphysema syndrome. LAMOTRIGINE dosage: 100MG PER DAY. During the same period patient was treated with ANAFRANIL, ZOLOFT. Patient died.
Lamotrigine Side Effects Report #5096589-2
Consumer or non-health professional from UNITED KINGDOM reported LAMOTRIGINE problem on Aug 15, 2006. Female patient, 14 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: bile duct stone, dilatation intrahepatic duct acquired, pancreatitis. LAMOTRIGINE dosage: unknown. During the same period patient was treated with VALPROATE, NORETHISTERONE. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5097872-7
LAMOTRIGINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 22, 2006. Female patient, 66 years of age, was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: anal sphincter atony. LAMOTRIGINE dosage: unknown. Patient recovered.
Lamotrigine Side Effects Report #5097873-9
Consumer or non-health professional from UNITED KINGDOM reported LAMOTRIGINE problem on Aug 22, 2006. Male patient was diagnosed with epilepsy and was treated with LAMOTRIGINE. LAMOTRIGINE dosage: unknown. During the same period patient was treated with VALPROATE, GABAPENTIN. Patient died.
Lamotrigine Side Effects Report #5099709-9
LAMOTRIGINE problem was reported by a Health Professional from UNITED STATES on Aug 03, 2006. Female patient was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: pyloric stenosis, vomiting. LAMOTRIGINE dosage: 100MG PER DAY. During the same period patient was treated with SEROQUEL, PRENATAL VITAMINS, FOLIC ACID, COCAINE, MARIJUANA. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5101399-3
Health Professional from UNITED STATES reported LAMOTRIGINE problem on Sept 05, 2006. Female patient was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: apnoea. LAMOTRIGINE dosage: 200MG PER DAY. During the same period patient was treated with ZOLOFT. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5102570-7
LAMOTRIGINE problem was reported by a Pharmacist from BELGIUM on Sept 08, 2006. Female patient, child 4 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: aggression. LAMOTRIGINE dosage: unknown. During the same period patient was treated with VALPROATE. Patient recovered.
Lamotrigine Side Effects Report #5103883-5
Physician from THAILAND reported LAMOTRIGINE problem on Sept 01, 2006. Female patient, 31 years of age, was diagnosed with major depression and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: eye pain, mouth ulceration, pharyngolaryngeal pain, pyrexia, rash erythematous, rash macular, rash morbilliform, skin discolouration, skin exfoliation. LAMOTRIGINE dosage: 25MG PER DAY. During the same period patient was treated with ENANTONE, PROGESTOGEN, RIVOTRIL, ZOLOFT. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5105887-5
LAMOTRIGINE problem was reported by a Health Professional from FRANCE on Sept 05, 2006. Female patient was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: jaundice neonatal. LAMOTRIGINE dosage: 100MG TWICE PER DAY. Patient recovered.
Lamotrigine Side Effects Report #5115722-7
Consumer or non-health professional from UNITED STATES reported LAMOTRIGINE problem on June 14, 2006. Female patient, 47 years of age, was diagnosed with depression and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: depression. LAMOTRIGINE dosage: 5MG TWICE PER DAY. During the same period patient was treated with CELEXA, EVOXAC, HYDROCORTISONE, HUMIBID, ESTROGEN REPLACEMENT. Patient recovered.
Lamotrigine Side Effects Report #5116229-3
LAMOTRIGINE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 22, 2006. Female patient, 22 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. LAMOTRIGINE dosage: 400MG PER DAY. During the same period patient was treated with FOLIC ACID. Patient recovered.
Lamotrigine Side Effects Report #5117752-8
Physician from THAILAND reported LAMOTRIGINE problem on Sept 01, 2006. Female patient, 40 years of age, weighting 119.0 lb, was diagnosed with major depression and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, eye pain, hepatic enzyme increased, mouth ulceration, pharyngolaryngeal pain, pyrexia, rash erythematous, rash macular. LAMOTRIGINE dosage: 25MG PER DAY. During the same period patient was treated with ENANTONE, PROGESTOGEN, RIVOTRIL, ZOLOFT, ANTICONVULSANT. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5118638-5
LAMOTRIGINE problem was reported by a Consumer or non-health professional from ISRAEL on Sept 25, 2006. Male patient was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: gamma-glutamyltransferase increased, haemolysis, jaundice. LAMOTRIGINE dosage: 200MG TWICE PER DAY. Patient recovered.
Lamotrigine Side Effects Report #5120333-3
Pharmacist from UNITED STATES reported LAMOTRIGINE problem on Oct 02, 2006. Female patient, 29 years of age, was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: rash. LAMOTRIGINE dosage: 25MG QHS PO. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5123299-5
LAMOTRIGINE problem was reported by a Consumer or non-health professional from CROATIA (local name: Hrvatska) on Oct 02, 2006. Female patient, child 4 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: lymphadenopathy, pseudomononucleosis, pyrexia, rash maculo-papular, splenomegaly. LAMOTRIGINE dosage: unknown. During the same period patient was treated with APILEPSIN, CLONAZEPAM. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5123835-9
Health Professional from UNITED STATES reported LAMOTRIGINE problem on Oct 05, 2006. Female patient, 37 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, ectopic pregnancy. LAMOTRIGINE dosage: 100MG PER DAY. During the same period patient was treated with TOPAMAX, PRENATAL VITAMINS, LYRICA. Patient recovered.
Lamotrigine Side Effects Report #5123836-0
LAMOTRIGINE problem was reported by a Health Professional from UNITED STATES on Oct 05, 2006. Female patient, 37 years of age, was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, pregnancy. LAMOTRIGINE dosage: 100MG PER DAY. During the same period patient was treated with CELEXA. Patient recovered.
Lamotrigine Side Effects Report #5125881-8
Consumer or non-health professional from INDIA reported LAMOTRIGINE problem on Aug 03, 2006. Male patient, 15 years of age, was diagnosed with depression and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: aggression, delusion of grandeur, insomnia, logorrhoea, mania, psychomotor hyperactivity. LAMOTRIGINE dosage: unknown. During the same period patient was treated with LITHIUM CARBONATE, OLANZAPINE. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5126991-1
LAMOTRIGINE problem was reported by a Health Professional from UNITED STATES on June 12, 2006. Male patient, weighting 5.73 lb, was diagnosed with maternal condition affecting foetus and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: cleft lip, cleft palate. LAMOTRIGINE dosage: unknown. Patient recovered.
Lamotrigine Side Effects Report #5127034-6
Consumer or non-health professional from UNITED KINGDOM reported LAMOTRIGINE problem on Oct 11, 2006. Female patient, 32 years of age, weighting 176.4 lb, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: hepatic failure, hepatitis. LAMOTRIGINE dosage: 100MG TWICE PER DAY. During the same period patient was treated with ACETAMINOPHEN. Patient died.
Lamotrigine Side Effects Report #5127709-9
LAMOTRIGINE problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Aug 16, 2006. Female patient, 19 years of age, was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: convulsion, erythema. LAMOTRIGINE dosage: unknown. During the same period patient was treated with DEPAKENE. Patient was hospitalized. Patient died.
Lamotrigine Side Effects Report #5129707-8
Physician from FRANCE reported LAMOTRIGINE problem on Oct 06, 2006. Female patient was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: cholestasis. LAMOTRIGINE dosage: 75MG PER DAY. During the same period patient was treated with ASPIRIN, DIHYDAN, NORSET, LEVOTHYROXINE, IMOVANE, SPECIAFOLDINE. Patient recovered.
Lamotrigine Side Effects Report #5131416-6
LAMOTRIGINE problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Aug 16, 2006. Female patient, 19 years of age, was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: convulsion, erythema. LAMOTRIGINE dosage: unknown. During the same period patient was treated with DEPAKENE. Patient was hospitalized. Patient died.
Lamotrigine Side Effects Report #5132721-X
Health Professional from FRANCE reported LAMOTRIGINE problem on Sept 05, 2006. Female patient was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: jaundice neonatal, premature baby. LAMOTRIGINE dosage: 100MG TWICE PER DAY. Patient recovered.
Lamotrigine Side Effects Report #5133631-4
LAMOTRIGINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Oct 11, 2006. Female patient, 32 years of age, weighting 176.4 lb, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: hepatic failure, hepatitis. LAMOTRIGINE dosage: 100 MG, BID, ORAL. During the same period patient was treated with ACETAMINOPHEN. Patient died.
Lamotrigine Side Effects Report #5134587-0
Health Professional from UNITED STATES reported LAMOTRIGINE problem on Oct 19, 2006. Female patient, 36 years of age, was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: abortion induced. LAMOTRIGINE dosage: unknown. During the same period patient was treated with MARIJUANA, ORTHO TRI, ABILIFY. Patient recovered.
Lamotrigine Side Effects Report #5135419-7
LAMOTRIGINE problem was reported by a Physician from RUSSIAN FEDERATION on July 27, 2006. Female patient, 23 years of age, weighting 149.9 lb, was diagnosed with partial seizures, epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: intentional overdose. LAMOTRIGINE dosage: unknown. During the same period patient was treated with VALPROIC ACID, CLONAZEPAM. Patient died on 07/25/2006.
Lamotrigine Side Effects Report #5136327-8
Pharmacist from AUSTRALIA reported LAMOTRIGINE problem on Oct 23, 2006. Female patient, 30 years of age, was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: electrocardiogram qt prolonged. LAMOTRIGINE dosage: 50MG SEE TEXT. During the same period patient was treated with EPILIM, EFFEXOR. Patient recovered.
Lamotrigine Side Effects Report #5142340-7
LAMOTRIGINE problem was reported by a Pharmacist from CANADA on Oct 06, 2006. Male patient, 15 years of age, weighting 220.5 lb, was diagnosed with psychotic disorder, affect lability and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: acne, psychiatric symptom, rash erythematous. LAMOTRIGINE dosage: 150MG PER DAY. During the same period patient was treated with ZYPREXA, CHLORPROMAZINE. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5142362-6
Health Professional from UNITED STATES reported LAMOTRIGINE problem on Oct 30, 2006. Female patient, 27 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: pregnancy induced hypertension, premature labour. LAMOTRIGINE dosage: 200MG PER DAY. During the same period patient was treated with PROZAC, SYNTHROID. Patient recovered.
Lamotrigine Side Effects Report #5144054-6
LAMOTRIGINE problem was reported by a Physician from ARGENTINA on Oct 27, 2006. Male patient, 31 years of age, was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. LAMOTRIGINE dosage: 100MG PER DAY. During the same period patient was treated with CLOZAPINE, CITALOPRAM HYDROBROMIDE. Patient was hospitalized. Patient recovered.
Lamotrigine Side Effects Report #5145015-3
Health Professional from UNITED STATES reported LAMOTRIGINE problem on Mar 03, 2006. Female patient, 21 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. LAMOTRIGINE dosage: unknown. Patient died.
Lamotrigine Side Effects Report #5146054-9
LAMOTRIGINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 22, 2006. Male patient, 29 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. LAMOTRIGINE dosage: unknown. During the same period patient was treated with EPILIM, GABAPENTIN. Patient died on 09/12/2000.
Lamotrigine Side Effects Report #5146892-2
Consumer or non-health professional from UNITED KINGDOM reported LAMOTRIGINE problem on Nov 03, 2006. Female patient, child 7 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: excessive masturbation, tic. LAMOTRIGINE dosage: unknown. During the same period patient was treated with VALPROATE. Patient recovered.
Lamotrigine Side Effects Report #5149246-8
LAMOTRIGINE problem was reported by a Health Professional from UNITED STATES on Nov 08, 2006. Female patient, weighting 5.73 lb, was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: choking, gastrooesophageal reflux disease, torticollis. LAMOTRIGINE dosage: unknown. Patient recovered.
Lamotrigine Side Effects Report #5149256-0
Health Professional from UNITED STATES reported LAMOTRIGINE problem on Nov 08, 2006. Female patient was diagnosed with bipolar disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: congenital anomaly, pregnancy. LAMOTRIGINE dosage: 50MG PER DAY. During the same period patient was treated with PAXIL, ATIVAN. Patient recovered.
Lamotrigine Side Effects Report #5150822-7
LAMOTRIGINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Sept 14, 2006. Female patient was diagnosed with petit mal epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: agitation neonatal. LAMOTRIGINE dosage: unknown. Patient recovered.
Lamotrigine Side Effects Report #5151277-9
Consumer or non-health professional from UNITED STATES reported LAMOTRIGINE problem on Nov 13, 2006. Male patient, weighting 70.00 lb, was diagnosed with petit mal epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, stevens-johnson syndrome. LAMOTRIGINE dosage: unknown. During the same period patient was treated with DEPAKOTE. Patient recovered.
Lamotrigine Side Effects Report #5151986-1
LAMOTRIGINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Nov 01, 2006. Male patient, 29 years of age, was diagnosed with epilepsy and was treated with LAMOTRIGINE. LAMOTRIGINE dosage: unknown. During the same period patient was treated with VALPROATE, GABAPENTIN. Patient died.
Lamotrigine Side Effects Report #5154773-3
Pharmacist from UNITED STATES reported LAMOTRIGINE problem on Nov 15, 2006. Male patient, weighting 220.0 lb, was diagnosed with affective disorder and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: rash. LAMOTRIGINE dosage: 25 MG QD FOR 14 DAYS PO; 50 MG QD THEREAFTER PO. Patient was hospitalized and became disabled. Patient recovered.
Lamotrigine Side Effects Report #5155075-1
LAMOTRIGINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 16, 2006. Male patient was diagnosed with convulsion and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: alopecia, aphasia, convulsion, libido decreased, memory impairment, mental impairment. LAMOTRIGINE dosage: 400MG PER DAY. Patient recovered.
Lamotrigine Side Effects Report #5155095-7
Physician from POLAND reported LAMOTRIGINE problem on Nov 15, 2006. Female patient was diagnosed with epilepsy and was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. LAMOTRIGINE dosage: 150MG PER DAY. Patient recovered.
Lamotrigine Side Effects Report #5158721-1
LAMOTRIGINE problem was reported by a Physician from BELGIUM on Sept 15, 2006. Male patient, 75 years of age, weighting 187.4 lb, was treated with LAMOTRIGINE. After drug was administered, patient experienced the following problems/side effects: depression, diabetes mellitus, hyperglycaemia, weight increased. LAMOTRIGINE dosage: 100MG PER DAY. During the same period patient was treated with SIPRALEXA, GLIMEPIRIDE, DEPAKENE, SERTRALINE, ASAFLOW, PRAZEPAM. Patient recovered.
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Drug Information: Lamotrigine
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a695007.html
(la moe' tri jeen)IMPORTANT WARNING:
| [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. |
IMPORTANT WARNING:
| 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. |
Why is this medication prescribed?
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.
How should this medicine be used?
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.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
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,
- tell your doctor and pharmacist if you are allergic to lamotrigine, or any other medications. If you will be taking the chewable dispersible tablets, tell your doctor if you are allergic to sulfa medications or saccharin.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and methotrexate (Rheumatrex, Trexall); other medications for seizures such as carbamazepine (Tegretol), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), and primidone (Mysoline); rifampin (Rifadin, Rimactane); and trimethoprim (Proloprim) . Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you are taking female hormonal medications such as hormonal contraceptives (birth control pills, patches, rings, injections, implants, or intrauterine devices), or hormone replacement therapy (HRT). Talk to your doctor before you start or stop taking any of these medications while you are taking lamotrigine. If you are taking a female hormonal medication, tell your doctor if you have any bleeding between expected menstrual periods.
- tell your doctor if you have or have ever had heart, kidney, or liver disease or a blood disorder.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking lamotrigine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lamotrigine.
- you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
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.
What side effects can this medication cause?
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:
- loss of balance or coordination
- double vision
- blurred vision
- crossed eyes
- difficulty thinking or concentrating
- difficulty speaking
- drowsiness
- dizziness
- vomiting
- diarrhea
- constipation
- heartburn
- problems with ears or teeth
- irritability
- nervousness
- mood changes
- difficulty falling asleep or staying asleep
- stomach, back, or joint pain
- runny nose
- cough
- missed or painful menstrual periods
- swelling, itching, or irritation of the vagina
- dry mouth
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:
- seizures that happen more often, last longer, or are different than the seizures you had in the past
- chest pain
- swelling of the hands, feet, ankles, or lower legs
- depression
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].
What storage conditions are needed for this medicine?
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 emergency/overdose
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:
- loss of balance or coordination
- crossed eyes
- increased seizures
- loss of consciousness
- coma
What other information should I know?
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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