1. APLASTIC ANEMIA
THE USE OF FELBATOL® (felbamate) IS ASSOCIATED
WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY,
FELBATOL® SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO
SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF
THE BENEFITS CONFERRED BY ITS USE (SEE
INDICATIONS). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR
CONTINUED ON FELBATOL® WITHOUT CONSIDERATION OF APPROPRIATE
EXPERT HEMATOLOGIC CONSULTATION.
AMONG FELBATOL® TREATED PATIENTS, APLASTIC ANEMIA
(PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED OF
HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE MORE THAN A
100 FOLD GREATER THAN THAT SEEN IN THE UNTREATED POPULATION (I.E., 2 TO
5 PER MILLION PERSONS PER YEAR). THE RISK OF DEATH IN PATIENTS WITH
APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND
ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE
RANGE OF 20 TO 30%, BUT RATES AS HIGH AS 70% HAVE BEEN
REPORTED IN THE PAST.
THERE ARE TOO FEW FELBATOL® ASSOCIATED CASES, AND TOO
LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE SYNDROME'S
INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE FACTORS, IF ANY,
THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS AT GREATER OR LESSER
IN MANAGING PATIENTS ON FELBATOL®, IT SHOULD BE BORNE IN
MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN
UNTIL AFTER A PATIENT HAS BEEN ON FELBATOL® FOR SEVERAL MONTHS
(E.G., ONSET OF APLASTIC ANEMIA AMONG FELBATOL® EXPOSED
PATIENTS FOR WHOM DATA ARE AVAILABLE HAS RANGED FROM 5 TO 30 WEEKS).
HOWEVER, THE INJURY TO BONE MARROW STEM CELLS THAT IS HELD TO BE
ULTIMATELY RESPONSIBLE FOR THE ANEMIA MAY OCCUR WEEKS TO MONTHS EARLIER.
ACCORDINGLY, PATIENTS WHO ARE DISCONTINUED FROM FELBATOL®
REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD
IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING APLASTIC
ANEMIA CHANGES WITH DURATION OF EXPOSURE. CONSEQUENTLY, IT IS NOT SAFE
TO ASSUME THAT A PATIENT WHO HAS BEEN ON FELBATOL® WITHOUT
SIGNS OF HEMATOLOGIC ABNORMALITY FOR LONG PERIODS OF TIME IS WITHOUT
IT IS NOT KNOWN WHETHER OR NOT THE DOSE OF FELBATOL®
AFFECTS THE INCIDENCE OF APLASTIC ANEMIA.
IT IS NOT KNOWN WHETHER OR NOT CONCOMITANT USE OF ANTIEPILEPTIC
DRUGS AND/OR OTHER DRUGS AFFECTS THE INCIDENCE OF APLASTIC ANEMIA.
APLASTIC ANEMIA TYPICALLY DEVELOPS WITHOUT PREMONITORY CLINICAL
OR LABORATORY SIGNS, THE FULL BLOWN SYNDROME PRESENTING WITH SIGNS OF
INFECTION, BLEEDING, OR ANEMIA. ACCORDINGLY, ROUTINE BLOOD TESTING
CANNOT BE RELIABLY USED TO REDUCE THE INCIDENCE OF APLASTIC ANEMIA, BUT,
IT WILL, IN SOME CASES, ALLOW THE DETECTION OF THE HEMATOLOGIC CHANGES
BEFORE THE SYNDROME DECLARES ITSELF CLINICALLY. FELBATOL®
SHOULD BE DISCONTINUED IF ANY EVIDENCE OF BONE MARROW DEPRESSION OCCURS.
EVALUATION OF POSTMARKETING EXPERIENCE SUGGESTS
THAT ACUTE LIVER FAILURE IS ASSOCIATED WITH THE USE OF
FELBATOL®. THE REPORTED RATE IN THE U.S. HAS BEEN ABOUT 6 CASES
OF LIVER FAILURE LEADING TO DEATH OR TRANSPLANT PER 75,000 PATIENT YEARS
OF USE. THIS RATE IS AN UNDERESTIMATE BECAUSE OF UNDER REPORTING, AND
THE TRUE RATE COULD BE CONSIDERABLY GREATER THAN THIS. FOR EXAMPLE, IF
THE REPORTING RATE IS 10%, THE TRUE RATE WOULD BE ONE CASE PER
1,250 PATIENT YEARS OF USE.
OF THE CASES REPORTED, ABOUT 67% RESULTED IN DEATH OR
LIVER TRANSPLANTATION, USUALLY WITHIN 5 WEEKS OF THE ONSET OF SIGNS AND
SYMPTOMS OF LIVER FAILURE. THE EARLIEST ONSET OF SEVERE HEPATIC
DYSFUNCTION FOLLOWED SUBSEQUENTLY BY LIVER FAILURE WAS 3 WEEKS AFTER
INITIATION OF FELBATOL®. ALTHOUGH SOME REPORTS DESCRIBED DARK
URINE AND NONSPECIFIC PRODROMAL SYMPTOMS (E.G., ANOREXIA, MALAISE, AND
GASTROINTESTINAL SYMPTOMS), IN OTHER REPORTS IT WAS NOT CLEAR IF ANY
PRODROMAL SYMPTOMS PRECEDED THE ONSET OF JAUNDICE.
IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING HEPATIC
FAILURE CHANGES WITH DURATION OF EXPOSURE.
IT IS NOT KNOWN WHETHER OR NOT THE DOSAGE OF FELBATOL®
AFFECTS THE INCIDENCE OF HEPATIC FAILURE.
IT IS NOT KNOWN WHETHER CONCOMITANT USE OF OTHER ANTIEPILEPTIC
DRUGS AND/OR OTHER DRUGS AFFECT THE INCIDENCE OF HEPATIC FAILURE.
FELBATOL® SHOULD NOT BE PRESCRIBED FOR ANYONE WITH A
HISTORY OF HEPATIC DYSFUNCTION.
TREATMENT WITH FELBATOL® SHOULD BE INITIATED ONLY IN
INDIVIDUALS WITHOUT ACTIVE LIVER DISEASE AND WITH NORMAL BASELINE SERUM
TRANSAMINASES. IT HAS NOT BEEN PROVED THAT PERIODIC SERUM TRANSAMINASE
TESTING WILL PREVENT SERIOUS INJURY BUT IT IS GENERALLY BELIEVED THAT
EARLY DETECTION OF DRUG-INDUCED HEPATIC INJURY ALONG WITH IMMEDIATE
WITHDRAWAL OF THE SUSPECT DRUG ENHANCES THE LIKELIHOOD FOR RECOVERY.
THERE IS NO INFORMATION AVAILABLE THAT DOCUMENTS HOW RAPIDLY PATIENTS
CAN PROGRESS FROM NORMAL LIVER FUNCTION TO LIVER FAILURE, BUT OTHER
DRUGS KNOWN TO BE HEPATOTOXINS CAN CAUSE LIVER FAILURE RAPIDLY (E.G.,
FROM NORMAL ENZYMES TO LIVER FAILURE IN 2-4 WEEKS). ACCORDINGLY,
MONITORING OF SERUM TRANSAMINASE LEVELS (AST AND ALT) IS RECOMMENDED AT
BASELINE AND PERIODICALLY THEREAFTER. WHILE THE MORE FREQUENT THE
MONITORING THE GREATER THE CHANCES OF EARLY DETECTION, THE PRECISE
SCHEDULE FOR MONITORING IS A MATTER OF CLINICAL JUDGEMENT.
FELBATOL® SHOULD BE DISCONTINUED IF EITHER SERUM AST OR
SERUM ALT LEVELS BECOME INCREASED ≥ 2 TIMES THE UPPER LIMIT OF
NORMAL, OR IF CLINICAL SIGNS AND SYMPTOMS SUGGEST LIVER FAILURE (SEE
PRECAUTIONS). PATIENTS WHO DEVELOP EVIDENCE OF
HEPATOCELLULAR INJURY WHILE ON FELBATOL® AND ARE WITHDRAWN FROM
THE DRUG FOR ANY REASON SHOULD BE PRESUMED TO BE AT INCREASED RISK FOR
LIVER INJURY IF FELBATOL® IS REINTRODUCED. ACCORDINGLY, SUCH
PATIENTS SHOULD NOT BE CONSIDERED FOR RE-TREATMENT.
Felbatol® (felbamate) is an antiepileptic available as 400 mg and 600 mg tablets and as a 600 mg/5 mL suspension for oral administration.
Felbatol® is not indicated as a first line antiepileptic treatment (see Warnings). Felbatol® is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
If these criteria are met and the patient has been fully advised of the risk, and has provided written, informed consent, Felbatol® can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Media Articles Related to Felbatol (Felbamate)
Epilepsy May Triple ADHD Risk, Danish Study Finds
Source: MedicineNet Seizure Specialty [2016.07.13]
Title: Epilepsy May Triple ADHD Risk, Danish Study Finds
Category: Health News
Created: 7/13/2016 12:00:00 AM
Last Editorial Review: 7/13/2016 12:00:00 AM
Suicide rate is 22% higher among people with epilepsy than the general population
Source: Caregivers / Homecare News From Medical News Today [2016.07.12]
Centers for Disease Control and Prevention issues first report on epilepsy and suicide.
New technique could revolutionize surgical treatment of epilepsy
Source: Epilepsy News From Medical News Today [2016.07.08]
Scientists at the University of Exeter have developed a pioneering new technique that could revolutionise the surgical treatment of epilepsy.
Can anti-inflammatory therapies be effective against epilepsy?
Source: Epilepsy News From Medical News Today [2016.07.07]
In epileptic patients, seizures lead to an increased level of inflammation-related proteins called chemokines in the brain, and systemic inflammation likely helps trigger and promote the recurrence...
Childhood-onset epilepsy has long-term effects on patients' health and social status
Source: Epilepsy News From Medical News Today [2016.06.21]
Children and adolescents with epilepsy experience significant long-term socioeconomic consequences and higher personal health care costs.
Published Studies Related to Felbatol (Felbamate)
Felbamate as an add-on therapy for refractory epilepsy. 
CONCLUSIONS: In view of the methodological deficiencies, limited number
Felbamate as an add-on therapy for refractory epilepsy. [2011.01.19]
CONCLUSIONS: In view of the methodological deficiencies, limited number of individual studies and differences in outcome measure, we have found no reliable evidence to support the use of felbamate as an add-on therapy in patients with refractory partial-onset epilepsy. A large scale, randomized controlled trial conducted over a greater period of time is required to inform clinical practice.
Felbamate as an add-on therapy for refractory epilepsy. 
CONCLUSIONS: In view of the methodological deficiencies, limited number
Low dose of bupropion significantly enhances the anticonvulsant activity of felbamate, lamotrigine and topiramate in mice. [2011.01.15]
Experimental evidence indicates that bupropion hydrochloride, an antidepressant and a first-line smoking cessation aid, exerts dose-dependently anticonvulsant and convulsant effects.A pharmacokinetic interaction is responsible for the effect of bupropion co-administered with lamotrigine.
[Felbamate crystalluria]. [2010.09]
This report describes the case of an 11-year-old child, who presents crystalluria occurring after several years of treatment with antiepileptic felbamate (Taloxa(R)). The crystalline morphologies observed were very heterogeneous, long and thin needle shapped-crystals or even hairy crystals or large needle asymmetric crystals...
Clinical Trials Related to Felbatol (Felbamate)
Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression [Completed]
The purpose of this study is to evaluate the safety and effectiveness of the drug felbamate
for treating depression in patients with bipolar disorder that has not responded to standard
Bipolar disorder is a severe, chronic, and often life-threatening illness. Despite the
availability of a wide range of antidepressant drugs, a proportion of patients fail to
respond to first-line antidepressant treatment despite adequate dosage, duration, and
compliance. Studies suggest that the glutamatergic system may play a role in the
pathophysiology and treatment of depression. Felbamate and other agents which reduce
glutamatergic neurotransmission may represent a novel class of antidepressants.
Participants in this study will be admitted to the Clinical Center for up to 10 weeks. At
study entry, participants will have a 7-day washout period in which they will be tapered off
all psychiatric medications, with the possible exception of lithium, and will be given a
placebo (an inactive pill). After the washout period, participants will be randomly assigned
to receive either felbamate or placebo for 8 weeks. Participants whose depression symptoms
worsen by more than 30% or those for whom study continuation is considered potentially
harmful will be taken off the study and offered open-label treatment. Participants who
received felbamate and responded well to treatment will have the option of continuing
Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database [Completed]
Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy;
however, complete seizure control remains elusive for many patients. Uncontrolled or
refractory epilepsy is associated with a higher risk of mortality, physical injuries, and
depression or anxiety compared with patients with controlled epilepsy. Higher resource
utilization for patients with poor control is likely to be associated with higher economic
costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists,
recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one
seizure per month and 2.) a history of drug failures.
The objective of this study is to identify patients with uncontrolled epilepsy in both a
Medicaid database and a private health plan database, to describe patient characteristics
and AED treatment patterns between cohorts of patients with uncontrolled versus
well-controlled epilepsy, and to evaluate the economic burden of uncontrolled versus
For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases
from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second
quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter
1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and
medical and pharmacy claims in an private health plan database.
The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient
records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy
(at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1
epilepsy-related inpatient or emergency department (ED) visit within 365 days),
well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits),
and intermediate epilepsy (not classified as uncontrolled or well-controlled).
Tetra-O-Methyl Nordihydroguaiaretic Acid in Treating Patients With Recurrent High-Grade Glioma [Completed]
RATIONALE: Drugs used in chemotherapy, such as tetra-O-methyl nordihydroguaiaretic acid
(EM-1421), work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of EM-1421 and to
see how well it works in treating patients with recurrent high-grade glioma.
Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy [Active, not recruiting]
This is an open randomized controlled study in children with mental retardation and
refractory epilepsy in which treatment with ketogenic diet (KD) is compared with treatment
with the antiepileptic drug (AED), not tried by the patient before, which we consider to be
the most appropriate AED for the patient.
Reports of Suspected Felbatol (Felbamate) Side Effects
Grand MAL Convulsion (7),
Decreased Appetite (6),
Weight Decreased (5),
Gastrooesophageal Reflux Disease (5),
Condition Aggravated (4),
Product Substitution Issue (3),
Treatment Noncompliance (3), more >>
Page last updated: 2016-07-13