Felbamate Safety Questions, Felbamate Answers
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Felbamate Safety Reports
Total Felbamate reports: 2.Felbamate FDA safety alerts: 2008 .
Reported hospitalizations: 2.
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Reported Felbamate Side Effects: sinus tachycardia, grand mal convulsion, electrocardiogram qrs complex prolonged, blood potassium decreased, nephrotic syndrome, nephrosclerosis.
More About Felbamate.
Felbamate Side Effects Report #5109879-1
Health Professional from UNITED STATES reported FELBAMATE problem on Sept 19, 2006. Male patient, 22 years of age, weighting 196.2 lb, was diagnosed with epilepsy and was treated with FELBAMATE. After drug was administered, patient experienced the following problems/side effects: nephrosclerosis, nephrotic syndrome. FELBAMATE dosage: 2800 MG 1 TID PO. During the same period patient was treated with DILANTIN, PREDNISONE, LUVOUX, NORVASC, LASIX. Patient was hospitalized. Patient recovered.
Felbamate Side Effects Report #5188734-5
FELBAMATE problem was reported by a Physician from UNITED STATES on Dec 01, 2006. Female patient, 22 years of age, was diagnosed with grand mal convulsion and was treated with FELBAMATE. After drug was administered, patient experienced the following problems/side effects: blood potassium decreased, electrocardiogram qrs complex prolonged, grand mal convulsion, sinus tachycardia. FELBAMATE dosage: 600 MG (3 IN 1 D), PO. During the same period patient was treated with LAMOTRIGINE. Patient was hospitalized. Patient recovered.
Drug Information: Felbamate
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a606011.html
(fel bam' ate)IMPORTANT WARNING:
| [Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.The drugs included in the analyses include (some of these drugs are also available in generic form): Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)Felbamate (marketed as Felbatol)Gabapentin (marketed as Neurontin) Lamotrigine (marketed as Lamictal) Levetiracetam (marketed as Keppra) Oxcarbazepine (marketed as Trileptal)Pregabalin (marketed as Lyrica) Tiagabine (marketed as Gabitril)Topiramate (marketed as Topamax) Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon) Zonisamide (marketed as Zonegran) Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm. |
IMPORTANT WARNING:
| Felbamate may cause a serious blood condition called aplastic anemia. Symptoms of aplastic anemia can start any time you are taking felbamate or for a period of time after stopping to take felbamate. Tell your doctor if you have or have ever had blood problems. Your doctor will probably tell you not to take felbamate. If you experience any of the following symptoms while taking felbamate or after you stop taking felbamate, call your doctor immediately: fever, sore throat, chills, other signs of infection, bleeding, easy bruising, extreme tiredness, weakness, or lack of energy.Felbamate may cause liver damage. Tell your doctor if you have or have ever had liver disease. Your doctor will probably tell you not to take felbamate. If you experience any of the following symptoms, call your doctor immediately: nausea, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, and flu-like symptoms.Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before, during, and after treatment to check your body's response to felbamate.Talk to your doctor about the risks of taking felbamate. You will have to sign an informed consent form before starting to take felbamate. |
Why is this medication prescribed?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Felbamate is used to treat certain seizures in adults and children with epilepsy whose seizures have not improved with other symptons. It is used alone or in combination with other medications to treat partial seizures in adults. It is used in combination with other medications to treat partial and generalized seizures in children with Lennox-Gastaut syndrome. Felbamate is in a class of medications called anticonvulsants. It works by decreasing abnormal activity in the brain.
How should this medicine be used?
Felbamate comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken with or without food three or four times a day. Take felbamate at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take felbamate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Shake the liquid well before each use to mix the medication evenly.
Your doctor will probably start you on a low dose of felbamate and gradually increase your dose every one or two weeks.
Felbamate controls seizures but does not cure them. Continue to take felbamate even if you feel well. Do not stop taking felbamate without talking to your doctor. If you suddenly stop taking felbamate, your seizures may become worse. Your doctor will probably decrease your dose gradually.
Other uses for this medicine
This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before taking felbamate,
- tell your doctor and pharmacist if you are allergic to felbamate; carbamate medications such as rivastigmine (Exelon), methocarbamol (Robaxin), and meprobamate (Miltown); or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), oral contraceptives (birth control pills), and valproate (Depacon). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had any of the conditions listed in the IMPORTANT WARNINGS section or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking felbamate, call your doctor.
- you should know that felbamate may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Felbamate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- heartburn
- vomiting
- constipation
- diarrhea
- weight loss
- difficulty falling asleep or staying asleep
- nervousness
- drowsiness
- swelling of the face
- runny nose
- differences in menstrual bleeding
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- hives
- rash
- itching
- difficulty breathing or swallowing
- rapid or pounding heartbeat
Felbamate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- upset stomach
- rapid heartbeat
What other information should I know?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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