Find information on thousands of medical conditions and prescription drugs.

Felbatol

Felbamate (marketed as Felbamol by MedPointe) is an anticonvulsant drug used in the treatment of epilepsy. It is used to treat partial seizures (with and without generalization) in adults and partial and generalized seizures associated with Lennox-Gastaut syndrome in children. However, an increased risk of potentially fatal aplastic anemia and/or liver failure limit the drugs usage to severe refractory epilepsy. more...

Home

Femara

Femring

Filipin

Flagyl

Flarex

Flavoxate

Flecainide

Flexeril

Flomax

Flonase

Flovent

FML

Focalin

Fosamax

Frova

Fuzeon

Mechanism of Action

As with most anticonvulsants, the precise mechanism is unknown. It has a weak inhibitory effect on GABA receptor binding sites.

Approval History

U.S.

August 1993. Felbamate was approved for partial seizures with and without secondary generalization in adults and for Lennox-Gastaut Syndrome, a serious form of childhood epilepsy. Over the following year 150,000 people were started on felbamate therapy and a third of these became established.

August 1st 1994. It was urgently withdrawn after 10 cases of aplastic anemia. A "Dear Doctor" letter was sent to 240,000 physicians.

September 27th 1994. Felbamate had a limited redemption in another "Dear Doctor" letter sent to 260,000 physicians. It was recommended that the drug remain available only for patients with severe epilepsy for whom the benefits outweigh the risks, and that changes be made to the product's labelling to reflect the newly recognized risk . This redemption came with an additional warning since there had been 10 cases acute liver failure (4 of which were fatal). At this point, 10,000 to 12,000 people remained on the drug.

U.K.

The drug is only available on a limited named-patient basis.

Indications & Usage

Adults: Monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization.
Children: Adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome.

Dosing

Felbamate is available in tablets (400 mg and 600 mg) and as a peach-coloured oral suspension (600 mg/5 mL).

Adults (> 14 years): begin with 1,200 mg daily given every 6 to 8 hours
Children (2 > 14 years): 15 to 45 mg per kg per day given every 6 to 8 hours

Side Effects

Adverse reactions include decreased appetite, vomiting, insomnia, nausea, dizziness, somnolence, and headache. Many patients report increased alertness with the drug. Two rare but very serious effects include aplastic anemia and hepatic (liver) failure. The risk of aplastic anemia is between 1:3,600 and 1:5,000, of which 30% of cases are fatal. The risk of hepatic failure is between 1:24,000 to 1:34,000.

Drug Interactions

Felbamate interacts with other AEDs, the dose of which may be reduced in order to avoid adverse effects.

Read more at Wikipedia.org

• [List your site here Free!]

Felbatol may cause acute liver failure - side effects of anti-epilepsy drug
From FDA Consumer, 12/1/94

Patients taking the anti-epilepsy drug Felbatol may develop acute liver failure, the drug's manufacturer, Carter-Wallace Inc., warned in a "Dear Doctor" letter to 260,000 physicians Sept. 21. These patients should contact their doctors as soon as possible about testing for liver problems.

FDA recommended that the letter be sent after receiving reports that 10 people taking Felbatol (felbamate) developed acute liver failure. At press time, four of these patients had died, and one survivor required a liver transplant. The patients, ages 2 to 28 years old, had been taking Felbatol for 14 to 257 days when liver failure was detected. Most patients had also been taking other anti-epileptic drugs.

In the letter, Carter-Wallace advised doctors to:

* not give Felbatol to patients with preexisting liver disease

* test patients for liver function before beginning Felbatol treatment

* monitor liver function with weekly blood tests during treatment

* take patients off Felbatol if liver problems are found.

Carter-Wallace had advised doctors two months earlier to restrict Felbatol use because 21 people taking it had developed aplastic anemia, a rare, frequently fatal disease in which the bone marrow stops making blood cells, and three had died. The company amended the drug's labeling, advising doctors to limit its use to patients whose epilepsy does not respond to alternative treatments and is so severe that the benefits outweigh the risks; 10,000 to 12,000 such patients remain on the drug.

FDA's Peripheral and Central Nervous System Drugs Advisory Committee met in September and recommended keeping the drug available for this limited population, adding information on the risk of liver disease to the labeling, and including a patient information sheet.

Felbatol was approved in August 1993 for partial seizures in adults and for Lennox-Gastaut syndrome, a serious form of childhood epilepsy. During the clinical trials, no cases of aplastic anemia or liver failure were reported.

Return to Felbatol

Home

Contact

Resources

Exchange Links

ebay