WARNING: SERIOUS SKIN RASHES
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 (
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.
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.
Published Studies Related to Lamotrigine
Lamotrigine in psychiatric disorders. 
CONCLUSIONS: Lamotrigine is recommended in bipolar maintenance when depression is
A factor analytic study in bipolar depression, and response to lamotrigine. 
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. 
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
Longitudinal changes in magnetisation transfer ratio in secondary progressive
multiple sclerosis: data from a randomised placebo controlled trial of
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.
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
Bioequivalence and Food Effect of 250mg of Lamotrigine XR [Active, not recruiting]
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures [Active, not recruiting]
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine)
extended-release with placebo in the treatment of PGTC seizures. LAMICTAL extended-release is
an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do
not contain active medication. In this study, LAMICTAL extended-release or placebo tablets
will be added to current seizure treatments.
Reports of Suspected Lamotrigine Side Effects
Maternal Exposure During Pregnancy (190),
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
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|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|
|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|
|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|
|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|
|Condition / reason:|| || Bipolar Disorder|
|Dosage & duration:|| || 25mg taken daily for the period of 10 days|
|Other conditions:|| || Anxiety|
|Other drugs taken:|| || N/A|
|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.|
Page last updated: 2014-12-01