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WARNING: SERIOUS SKIN RASHES
LAMICTAL® 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 LAMICTAL 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 LAMICTAL as initial monotherapy and 0.13% (1.3 per 1,000) in adult patients receiving LAMICTAL as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients (2 to 16 years of age) with epilepsy taking adjunctive LAMICTAL, 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 LAMICTAL. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of LAMICTAL with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL, or (3) exceeding the recommended dose escalation for LAMICTAL. However, cases have occurred in the absence of these factors.
Nearly all cases of life-threatening rashes caused by LAMICTAL 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 LAMICTAL, it is not possible to predict reliably which rashes will prove to be serious or life-threatening. Accordingly, LAMICTAL 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] .
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LAMICTAL SUMMARY
LAMICTAL (lamotrigine), an antiepileptic drug (AED) of the phenyltriazine class, is chemically unrelated to existing antiepileptic drugs.
Adjunctive Use: LAMICTAL is indicated as adjunctive therapy for partial seizures in adults and pediatric patients (>/=2 years of age).
LAMICTAL is also indicated as adjunctive therapy for the generalized seizures of Lennox-Gastaut syndrome in adult and pediatric patients (>/=2 years of age).
Monotherapy Use: LAMICTAL 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 LAMICTAL 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).
Safety and effectiveness in patients below the age of 16 other than those with partial seizures and the generalized seizures of Lennox-Gastaut syndrome have not been established (see BOXED WARNING).
Bipolar Disorder: LAMICTAL 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 LAMICTAL in the acute treatment of mood episodes has not been established.
The effectiveness of LAMICTAL 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 LAMICTAL for periods extending beyond 18 months should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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NEWS HIGHLIGHTSMedia Articles Related to Lamictal (Lamotrigine)
FDA Warns Lamictal Can Cause Meningitis
Source: MedicineNet lamotrigine Specialty [2010.08.13]
Title: FDA Warns Lamictal Can Cause Meningitis
Category: Health News
Created: 8/13/2010 11:24:00 AM
Last Editorial Review: 8/13/2010 11:24:04 AM
Published Studies Related to Lamictal (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...
Clinical Trials Related to Lamictal (Lamotrigine)
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.
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.
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.
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients [Recruiting]
The study will be a multi-center, parallel, group, placebo control, double-blind, randomized
controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged
10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen
(approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36
weeks) and Taper and follow-up phase (up to 4 weeks).
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures [Completed]
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine)
extended-release with placebo in the treatment of partial 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 Lamictal (Lamotrigine) Side Effects
Rash (423),
Pyrexia (329),
Stevens-Johnson Syndrome (197),
Erythema (163),
Drug Eruption (155),
Convulsion (153),
Alanine Aminotransferase Increased (141),
Drug Rash With Eosinophilia and Systemic Symptoms (139),
C-Reactive Protein Increased (121),
Aspartate Aminotransferase Increased (117), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 40 ratings/reviews, Lamictal has an overall score of 7.72. The effectiveness score is 8.35 and the side effect score is 7.85. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Lamictal review by 46 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | bipolar depression |
| Dosage & duration: | | 100MG taken 3/day for the period of 4 years |
| Other conditions: | | Allergies; back pain |
| Other drugs taken: | | Effexor; Allegra; Ketoprofen; Viagra | | |
Reported Results |
| Benefits: | | The combination of Lamictal and Effexor eliminated severe mood swings betweens hypomania and depression, and made my depression manageable. |
| Side effects: | | Possibly minor sexual side effects: more difficult to reach organism. |
| Comments: | | Morning: 1 capsule (150MG) Effexor XR; 1 tablet 100MG Lamictal.
Evening: 2 tablets 100MG Lamictal. |
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| | Lamictal review by 28 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar |
| Dosage & duration: | | 200 MG taken once daily for the period of 8 months |
| Other conditions: | | N/A |
| Other drugs taken: | | Effexor 300 MGs | | |
Reported Results |
| Benefits: | | I was hospitalized in January for suicidal thoughts/attempts. At the time, I had been diagnosed with clinical depression and prescriped antidepressants only. They would induce mania and I was totally out of control, so much so that I pretty much lost all of my friends and went through a divorce. At the hospital, I was diagnosed as bipolar and since taking Lamotrogine with Effexor, I've had no thoughts of suicide or cutting, which I used to do often. |
| Side effects: | | Some dizziness and vertigo. |
| Comments: | | Started out with 50 MGs and went up to 200 MGs slowly. I haven't had any severe side effects, just the same I had with antidepressants. |
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| | Lamictal review by 39 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar II |
| Dosage & duration: | | 100mg taken qd for the period of 22 months |
| Other conditions: | | N/A |
| Other drugs taken: | | Wellbutrin | | |
Reported Results |
| Benefits: | | The drug stabilized my rapid cycling. It facilitated my reducing alcohol consumption to decrease my hypomanic symptoms. |
| Side effects: | | I had severe suicidal thoughts, severe depression and feelings of isolation, and absolutely no motivation for life. FDA has issued statement that patients are twice as likely to experience suicidal thoughts/ideation on this drug than on placebo. Unfortunately, I was on this drug for 15 months before this information was released and an additional 7 months before I read about it. My psychiatrist (outside the U.S.) was not notified about this potential side effect. I feel like I lost almost two years of my life. |
| Comments: | | QD A.M.: 150 mg Wellbutrin
QD A.M.: 100 mg Lamictal |
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Page last updated: 2013-02-10
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