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Lamotrigine (Lamotrigine) - Summary

 
 



BOXED WARNING

SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF LAMOTRIGINE. THE INCIDENCE OF THESE RASHES, WHICH HAVE INCLUDED STEVENS-JOHNSON SYNDROME, IS APPROXIMATELY 0.8% (8 PER 1,000) IN PEDIATRIC PATIENTS (AGE <16 YEARS) 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 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 ASSOCIATED WITH 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 BEEN REPORTED IN THE ABSENCE OF THESE FACTORS.

NEARLY ALL CASES OF LIFE-THREATENING RASHES ASSOCIATED WITH LAMOTRIGINE HAVE OCCURRED WITHIN 2 TO 8 WEEKS OF TREATMENT INITIATION. HOWEVER, ISOLATED CASES HAVE BEEN REPORTED AFTER PROLONGED TREATMENT (E.G., 6 MONTHS). ACCORDINGLY, DURATION OF THERAPY CANNOT BE RELIED UPON AS A MEANS TO PREDICT THE POTENTIAL RISK HERALDED BY THE FIRST APPEARANCE OF A RASH.

ALTHOUGH BENIGN RASHES ALSO OCCUR WITH 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.

 

LAMOTRIGINE SUMMARY

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

Epilepsy:

Adjunctive Use:

Lamotrigine is indicated as adjunctive therapy for partial seizures, the generalized seizures of Lennox-Gastaut syndromein adults and pediatric patients (≥2 years of age).

Monotherapy Use

Lamotrigine is indicated for conversion to monotherapy in adults with partial seizures. who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single 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 (see DOSAGE AND ADMINISTRATION).

Bipolar Disorder :

Lamotrigine is indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients 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 of 18 months' duration in patients with Bipolar I Disorder as defined by DSM-IV (see CLINICAL STUDIES: Bipolar Disorder). The physician who elects to use lamotrigine for periods extending beyond 18 months should periodically re-evaluate the long-term usefulness of the drug for the individual patient.


See all Lamotrigine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Lamotrigine

Lamotrigine stopped ribosomes from being created, may be key to new antibiotics
Source: MRSA / Drug Resistance News From Medical News Today [2014.09.24]
McMaster scientists have found that an anticonvulsant drug may help in developing a new class of antibiotics.

more news >>

Published Studies Related to Lamotrigine

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.

A double-blind placebo-controlled trial of lamotrigine as an antidepressant augmentation agent in treatment-refractory unipolar depression. [2011.10]
CONCLUSIONS: This add-on study of patients with treatment-resistant depression failed to detect a statistically significant difference between lamotrigine and placebo given for 10 weeks. However, post hoc analyses suggest that future studies of lamotrigine's efficacy might focus on specific subgroups with depression. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00901407. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

Effects of lamotrigine and phenytoin on the pharmacokinetics of atorvastatin in healthy volunteers. [2011.07]
PURPOSE: Statins and antiepileptic drugs (AEDs) are frequently coprescribed to individuals with hypercholesterolemia and new-onset seizures...

more studies >>

Clinical Trials Related to Lamotrigine

Lamotrigine Therapy in Geriatric Bipolar Depression [Recruiting]
We propose to study the efficacy and tolerability of lamotrigine in the treatment of older adults with bipolar depression and to compare measures of brain energy metabolism between older subjects with bipolar depression and healthy age-matched controls in order to better understand treatment response in geriatric bipolar depression.

LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures [Completed]
This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10. 2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.

Lamotrigine and Oral Contraceptives [Terminated]
The present study evaluates the effect of oral contraceptives on lamotrigine plasma concentrations in a double blind, placebo controlled, cross-over study in patients with epilepsy.

Bioequivalence and Food Effect of 250mg of Lamotrigine XR [Active, not recruiting]

Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression [Recruiting]
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.

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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

  Rating
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

  Rating
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: 2014-09-24

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