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Lamotrigine (Lamotrigine) - Summary



Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (2 to 16 years of age) receiving Lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08% (0.8 per 1,000) in adult patients receiving Lamotrigine as initial monotherapy and 0.13% (1.3 per 1,000) in adult patients receiving Lamotrigine as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients (2 to 16 years of age) with epilepsy taking adjunctive Lamotrigine, there was 1 rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.

Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by Lamotrigine. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of Lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of Lamotrigine, or (3) exceeding the recommended dose escalation for Lamotrigine. However, cases have occurred in the absence of these factors.

Nearly all cases of life-threatening rashes caused by Lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash.

Although benign rashes are also caused by Lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life-threatening. Accordingly, Lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring [see Warnings and Precautions ( 5.1 )].



Lamotrigine USP, an antiepileptic drug (AED) of the phenyltriazine class, is chemically unrelated to existing antiepileptic drugs.


Adjunctive Therapy: Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age:

  • partial seizures
  • primary generalized tonic-clonic seizures
  • generalized seizures of Lennox-Gastaut syndrome

Monotherapy: Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).

Safety and effectiveness of Lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

Bipolar Disorder

Lamotrigine tablets are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (≥18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of Lamotrigine in the acute treatment of mood episodes has not been established.

The effectiveness of Lamotrigine as maintenance treatment was established in 2 placebo-controlled trials in patients with Bipolar I Disorder as defined by DSM-IV [ see Clinical Studies (14.2) ]. The physician who elects to prescribe Lamotrigine for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

See all Lamotrigine indications & dosage >>


Published Studies Related to Lamotrigine

Lamotrigine in psychiatric disorders. [2013]
CONCLUSIONS: Lamotrigine is recommended in bipolar maintenance when depression is

A factor analytic study in bipolar depression, and response to lamotrigine. [2013]
sample... CONCLUSION: This study has identified 7 factors of the HDRS in a large sample of

Analysis of three lamotrigine extended-release clinical trials: comparison of pragmatic ITT and LOCF methodologies. [2012]
Early withdrawal of patients from a clinical trial can compromise the robustness of the data by introducing bias into the analysis. This is most commonly addressed by using the "intent to treat" (ITT) population and "last observation carried forward" (LOCF) methodology, where a patient's last assessment is carried forward.

Longitudinal changes in magnetisation transfer ratio in secondary progressive multiple sclerosis: data from a randomised placebo controlled trial of lamotrigine. [2012]
Sodium blockade with lamotrigine is neuroprotective in animal models of central nervous system demyelination. This study evaluated the effect of lamotrigine on magnetisation transfer ratio (MTR), a putative magnetic resonance imaging measure of intact brain tissue, in a group of subjects with secondary progressive multiple sclerosis (MS)...

Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. [2011.10]
BACKGROUND: Efficacious and safe monotherapy options are needed for adult patients with newly diagnosed epilepsy. As an adjunctive treatment for partial seizures, pregabalin compares favourably with lamotrigine and is an effective, approved treatment. We studied the efficacy and safety of pregabalin as monotherapy, using a design that complied with European regulatory requirements and International League Against Epilepsy guidelines... INTERPRETATION: Pregabalin has similar tolerability but seems to have inferior efficacy to lamotrigine for the treatment of newly diagnosed partial seizures in adults. Inferior efficacy of pregabalin might have been attributable to limitations in the study design, as treatment doses might have not been optimised adequately or early enough. FUNDING: Pfizer Inc. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

more studies >>

Clinical Trials Related to Lamotrigine

Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression [Completed]
Depression is a medical condition characterized by feeling sad even when good things happen, having low energy and motivation, and sometimes even experiencing suicidal thoughts. Bipolar II Disorder is an illness in which periods of depression alternate with periods of abnormally elevated mood, energy and activity, referred to as hypomania. After Major Depressive Disorder, Bipolar II Disorder is the most common cause of depression. Unfortunately, antidepressant medications, used alone, do not work as well in treating Bipolar depression as they do in treating other kinds of depression. Lamotrigine is a medication which studies show is effective in treating Bipolar depression. The investigators will determine if lamotrigine works best to treat Bipolar II depression if it is used alone, or if it is taken with an antidepressant. In the first part of our investigation, people with Bipolar II depression who have not responded to an antidepressant will either add lamotrigine to their antidepressant, or will stop the antidepressant and take lamotrigine alone. They will see the study doctor for 6 visits over 8 weeks, and will answer questions about their depressive symptoms and their overall health. The purpose of this study phase is to determine which treatment works best to treat active Bipolar depression. In the second part of the study, people who have responded to their assigned treatment may continue to receive it for another 44 weeks. They will see the study doctor monthly, and will answer similar questions about their health. Participants will also receive a physical examination and get a blood test three times during the study. The purpose of the second phase is to ascertain which treatment is best at preventing relapses of depression. The investigators hypothesize that people who take Lamotrigine plus an antidepressant will recover from their depression more completely, have a longer period of wellness, and have better quality of life compared to those taking Lamotrigine alone.

Lamotrigine for Symptoms of Geriatric Bipolar Depression [Completed]
This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and

Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting

inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.

The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg [Completed]
This is an open-label, randomised, parallel-group study to demonstrate the bioequivalence of lamotrigine 100mg in two different formulations, dispersible/chewable tablet and compressed tablet, in healthy subjects under fasting conditions. Subjects will be randomized in equal numbers to be dosed with either lamotrigine dispersible/chewable (Test) 100mg tablet or lamotrigine compressed (Reference) 100mg tablet. Pharmacokinetic blood sampling will be collected over 216 hours post dose. Safety (tolerability) will be observed up to 216 hours post dose. Safety assessments will include regular monitoring of vital signs, ECG's, adverse events (AEs) and safety laboratory tests. A follow-up visit is scheduled within 10-17 days post-dose.

Lamotrigine Pregnancy Registry (LAM05) [Completed]
Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with epilepsy, and other approved indications including bipolar disorder, may require or be unintentionally exposed to AEDs during pregnancy. Prior to an AED being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The International Lamotrigine Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1992 to monitor the safety of lamotrigine during pregnancy.

Study of Lamotrigine to Treat Ménière's Disease [Recruiting]
This double-blinded study evaluates the frequency of vertigo attacks and the quality of life of patients diagnosed with Mnire's disease after being randomly assigned to take a placebo or lamotrigine.

more trials >>

Reports of Suspected Lamotrigine Side Effects

Maternal Exposure During Pregnancy (190)Convulsion (184)Rash (109)Maternal Drugs Affecting Foetus (106)Completed Suicide (105)Toxicity TO Various Agents (96)Drug Ineffective (86)Drug Rash With Eosinophilia and Systemic Symptoms (82)Haemoglobin Decreased (82)Foetal Exposure During Pregnancy (76)more >>


Based on a total of 12 ratings/reviews, Lamotrigine has an overall score of 6.25. The effectiveness score is 7.67 and the side effect score is 6.17. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Lamotrigine review by 32 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   Bipolar 2-Extreme moods swings
Dosage & duration:   150 mg taken 1xnightly for the period of 2 months
Other conditions:   bulimia, depression
Other drugs taken:   none
Reported Results
Benefits:   My miracle drug!! I have suffered for years with extreme mood swings, depression, and bulimia. It was several months ago that I was diagnosed with bipolar 2-I was immediately prescribed Lamictal-I didn't really notice a difference so my dr. upped it to 150mg. It has worked wonders! I am so proud to say that I am happy and I haven't felt this elation in years! I can actually stay awake during the day, I have the drive to exercise, my labido is back(sure did miss that), almost no mood swings at all and most importantly I feel like a mother again! I have 3 beautiful little girls that I can hug, kiss, and love again!! I feel like crying-in a good way-everytime I think about how happy I am! My only fear is wondering how long this will last-I can only pray this will last forever.
Side effects:   The only side effects I have (I consider 2 of these not even side effects at all)headaches, staying asleep at night, weird fever like feeling, increase in sexual drive and weight loss. All are tolerable considering the benefits.
Comments:   150 mg a day-taken before bedtime


Lamotrigine review by 55 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   depression and anxiety
Dosage & duration:   200 mg taken once a day for the period of one month
Other conditions:   anxiety
Other drugs taken:   none
Reported Results
Benefits:   Raise the platform of being less anxious
Side effects:   Reduction in motor skills and memory loss
Comments:   Began taking a doseage of 35 and increased to 200 mg. at 150 and 200 noticed lack of balance and reduction of motor skills. Immediately reduced to 75 which was perfect for the patient but well below the recommended level of 200 to 400 mg.


Lamotrigine review by 19 year old female patient

Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   Bipolar Disorder
Dosage & duration:   25mg taken daily for the period of 10 days
Other conditions:   Anxiety
Other drugs taken:   N/A
Reported Results
Benefits:   I felt better for the first few days, mood-wise. But then I got depressed again. So I guess that's not a benefit.
Side effects:   I've always been one to freak out at the slightest appearance of illness - I have anxiety as well as bipolar disorder. When I was told that lamotrigine (the first drug I've been on for bipolar) caused a potentially fatal rash, I decided that this time, I was going to try not to worry. One out of ten people experience a rash on the drug - and I tried to be rational - that means I'm likely to be one of the nine that doesn't. Oh, was I ever wrong. Firstly, the lamotrigine didn't help with moods. I wanted to die for two days more badly than I ever had in my life on this drug. It was excruciating. Luckily, I have a lot of support, and I (obviously) didn't kill myself. I couldn't sleep. I lay awake most nights until 7am. I eventually passed out and got maybe 4-6 hours of sleep. This is barely better than the sleep I get when I'm hypomanic. And we all know how bad it is when bipolar people don't sleep. Luckily, the meds did seem to keep me from going upwards mood-wise. I also had to pee ALL THE TIME, which was not fun. That brings me to the rash. I first noticed a few raised bumps on my inner forearms. I thought it would go away, that I shouldn't freak out - I wasn't going to get the rash, right? And the next morning, I was covered in a slightly raised, red rash, even on my face and hands. I went to the clinic, and the doctor said I was having an allergic reaction. He told me to just go home and stop taking the lamotrigine. He knew nothing about it or the fact that it causes rashes. It got worse, and by night-time I was freaked out. I called a nurse and she told me to go to the emergency room. I did, and they had me stay the night to make sure I didn't have Steven Johnson Syndrome. Luckily, I don't. I just have something called "drug eruption." Even if it's not going to kill me, it's never fun being covered in red blotches. I still am and it's been three days. I'm afraid to go to the Starbucks around the corner. My verdict? Lamictal isn't worth it. Don't risk it.
Comments:   I was put on 12.5mg, then 25mg, and we were going to keep raising the dose slowly to minimize risk.

See all Lamotrigine reviews / ratings >>

Page last updated: 2014-12-01

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