Need help With Felbatol

[Duke]

Dr. got me to my full dosage of Felbatol 800mg 3 times a day along
Zonegran200mg morn. & 400mg night
Lamictal 250 2 times a day
Lyrica150mg morn. & 225mg night

when I started taking the Felbatol, I noticed a lot of scratching. Mostly from my knees down and some on my arms. I mean the sratchting just gets worse. Are there any side effects that I should be concerned about with Felbetol?
The only one I know of is about your Liver and somthing about a bone disorder. So chime in if you have some advice. Thanks,
Duke

[Dutch mom]

Hello,

Felbatol (Taloxa is the brand name in Holland) is used for kids with the Lennox Gastaut syndrome when other meds don't help. 30% seizure reduction is considered succesfull in kids with Lennox-Gastaut Syndrome using felbamate. My son got it prescribed 5 years ago. We started the med and after 3 days we ended up in the hospital with our son in a coma-like status (never happend before and never happened again after stopping felbamate.)
I did some research and got really scared about the potential fatal side effects of this med, in particular aplastic anemia and hepatic failure. And I got in contact with several parents of kids with a dangerous reduction of white blood cells in their bones as a side effect of felbamate (in two cases perrmanent.)
What scared me most was that those side affects even can appear years later, even when the med is not used anymore.

We decided to stop the felbamate after 3 days and decided to try the ketogenic diet because we had no alternative meds anymore on our list. For my boy this was a golden decision, the ketogenic diet did help to reduce his seizures and helped to get him med free.

I have these links in my archive about felbamate.

Felbamate

In 1993 the efficacy of felbamate (FBM) was documented in a double-blind, placebo-controlled trial.36 Seizure frequency was assessed by guardian report and by serial 4-hour EEG-video monitoring sessions during the course of the study. FBM significantly reduced the number of atonic seizures compared to placebo in both the treatment (p = 0.01) and the maintenance (p = 0.002) phases of the study. Of the 37 patients who received FBM, 3 were without atonic seizures during the treatment phase, and 5 had no atonic seizures during the maintenance phase. A dose-response relationship was demonstrated for reduction of atonic seizures, with a linear reduction in the number of atonic seizures per day with increasing plasma FBM levels. There was a statistically significant reduction in seizure frequency for all seizure types among the FBM-treated patients compared to those who received placebo (p = 0.002).

‘Global evaluations’ of patient functioning and neuropsychological tests were performed on all study subjects in order to assess non-seizure-related outcomes. The global evaluation scores during the maintenance period were significantly higher (p < 0.001) among the FBM group than the placebo group.

Dodson reported the 12-month open-label study of FBM that followed the clinical trial.37 Those who converted from placebo to FBM had the same degree of improvement on FBM as those who received FBM during the trial. At the end of the double-blind trial only 2 of the 22 subjects randomized to placebo had experienced a > 50% reduction in atonic seizure. However, during the first month that these patients from the placebo group were treated with FBM 12 of the 22 subjects (55%) had a > 50% reduction in atonic seizures. Combining both the groups of patients from the randomized double-blind trial in the follow-on study, 33 of 50 or approximately two-thirds had a > 50% reduction of atonic seizures 12 months after beginning the open-label study.

No pattern of serious adverse events due to FBM was apparent at the time of FDA approval in 1993. By the summer of 1994 120,000 patients had been exposed to FBM and reports of both aplastic anemia and hepatic failure had been reported to Wallace Laboratories and the FDA. After letters had been sent to over 200,000 physicians in the USA informing them of these new risks, most patients were withdrawn from FBM and the use of FBM in Lennox-Gastaut Syndrome declined.

Over the last four years analysis of the available data have led to a better estimate of the risk of FBM. Kaufman, et.al. reviewed all case reports of aplastic anemia among patients treated with FBM. The incidence of aplastic anemia among those treated with FBM was estimated to have a lower limit of 1 per 37,037 patients and an upper limit of 1 per 4784 patients, with a "most probable" incidence of 1 per 7874 patients treated.38

Pellock and Brodie estimated that the incidence of hepatotoxicity to be about 1 per 26,000–34,000 patients treated with FBM 39 – similar to the recently reported risk of hepatotoxicity for valproate (VPA).40 No children under the age of 13 years have been reported to have FBM-related aplastic anemia. Female sex, history of immune disorders (e.g., lupus), a history of prior blood dyscrasias, and allergic reactions to medications are probably associated with increased risk for FBM-associated aplastic anemia. These factors may later prove helpful in selecting patients for FBM treatment.

http://neurologia.rediris.es/congres...ilepsia-8.html

and

http://www.drugs.com/pdr/FELBAMATE.html

[drarvindr]

I agree with dutch mom abt the side effects. The itching and rash you experence could be early signs of an allergy to the medication. Ask your doctor for details and investigations. DO NOT STOP THE DRUG ON YOUR OWN. get well soon

[Duke]

Dutch mom
thanks for the link on Felbatol, got a lot of of info there.

drarvindr, I'll talk to my Dr. about the itching and see what he tells me to be whatching for. Thanks,
Duke

[Cint]

I thought they only used Felbatol now on patients whose seizures are SO severe that nothing else works because it can cause Aplastic Anemia, Hepatic Failure. My epileptologist had me try it back in the early 90s when it first was on the market, but I couldn't handle it at all. It caused severe migraines for me.

Cindy

[Dutch mom]

"mild itching or skin rash" is considered a less serious side effect here:
http://www.revolutionhealth.com/drug...ents/felbamate

This one is interesting too, a consensus text on felbatol, mention the specialst 's comments. http://professionals.epilepsy.com/page/hc_felbate.html

[Cint]

Dutch mom,

Georgia Montouris, who is on the epilepsy.com website that you posted, used to be my epileptologist. At the time, she was at the Epilepsy-Care Center in Memphis, TN. IMO, she is one of the best! A very caring, compassionate doctor. I was one of the ones to use Felbamate when it first came out on the market in the early 90's. For me, it was one of the worst drugs to take!

Cindy

[brain]

Dutch mom,

Georgia Montouris, who is on the epilepsy.com website that you posted, used to be my epileptologist. At the time, she was at the Epilepsy-Care Center in Memphis, TN. IMO, she is one of the best! A very caring, compassionate doctor. I was one of the ones to use Felbamate when it first came out on the market in the early 90's. For me, it was one of the worst drugs to take!

Cindy

That was one of the Questions my Neurologist at
Cleveland Clinic Florida asked me was about Felbatol,
I told her "If you put me back on that, I'd shoot the pills!"

I wasn't kidding ...