Gabapen Safety Questions, Gabapen Answers
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Gabapen Safety Reports
Total Gabapen reports: 77.Gabapen FDA safety alerts: 2005 2008 .
Reported deaths: 41 Reported hospitalizations: 123.
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Reported Gabapen Side Effects: somnolence, epilepsy, convulsion, depressed level of consciousness, pyrexia, fall, altered state of consciousness, white blood cell count decreased, platelet count decreased, movement disorder, gastrointestinal haemorrhage.
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Showing 1-50 of 77 Next >
Gabapen Side Effects Report #5335336-3Physician from JAPAN reported GABAPEN problem on May 14, 2007. Male patient, 30 years of age, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: convulsion. GABAPEN dosage: DAILY DOSE:1200MG-FREQ:DAILY. During the same period patient was treated with CARBAMAZEPINE. Patient recovered.
Gabapen Side Effects Report #5339033-X
GABAPEN problem was reported by a Physician from JAPAN on May 18, 2007. Male patient, weighting 136.7 lb, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: hypochloraemia, hyponatraemia. GABAPEN dosage: unknown. During the same period patient was treated with HYSERENIN, TEGRETOL, RIVOTRIL, LAC B. Patient recovered.
Gabapen Side Effects Report #5354870-3
Physician from JAPAN reported GABAPEN problem on May 31, 2007. Female patient, weighting 196.2 lb, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour. GABAPEN dosage: DAILY DOSE:800MG. During the same period patient was treated with HYDANTOL, DEPAKENE, RIVOTRIL, PRIMIDONE, DIAMOX. Patient recovered.
Gabapen Side Effects Report #5361023-1
GABAPEN problem was reported by a Physician from JAPAN on June 06, 2007. Female patient, 28 years of age, was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: liver disorder, platelet count decreased, pyrexia. GABAPEN dosage: DAILY DOSE:900MG. During the same period patient was treated with PREDONINE, MEXITIL, ALFAROL, GASTER. Patient recovered.
Gabapen Side Effects Report #5364017-5
Physician from JAPAN reported GABAPEN problem on June 08, 2007. Female patient, weighting 112.4 lb, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: obsessive thoughts, persecutory delusion. GABAPEN dosage: unknown. During the same period patient was treated with ALEVIATIN, TEGRETOL, DEPAKENE, FAMOTIDINE. Patient recovered.
Gabapen Side Effects Report #5372825-X
GABAPEN problem was reported by a Physician from JAPAN on June 15, 2007. Male patient, 57 years of age, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: anuria, eosinophil count increased, pyrexia, renal impairment. GABAPEN dosage: DAILY DOSE:1800MG. During the same period patient was treated with TEGRETOL, PHENOBARBITAL, DEPAKENE, SOLANAX, TERNELIN, TRYPTANOL. Patient was hospitalized and became disabled. Patient recovered.
Gabapen Side Effects Report #5161355-6
Physician from JAPAN reported GABAPEN problem on Nov 09, 2006. Female patient, 60 years of age, was diagnosed with tonic convulsion and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, epilepsy. GABAPEN dosage: 400 MG DAILY, ORAL. During the same period patient was treated with PHENYTOIN, PHENOBARBITAL, ZONISAMIDE. Patient recovered.
Gabapen Side Effects Report #5194371-9
GABAPEN problem was reported by a Physician from JAPAN on Dec 16, 2006. Female patient was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: epilepsy. GABAPEN dosage: DAILY DOSE:1800MG. During the same period patient was treated with TEGRETOL, DEPAKENE, RIVOTRIL. Patient recovered.
Gabapen Side Effects Report #5195118-2
Physician from JAPAN reported GABAPEN problem on Dec 14, 2006. Male patient, 40 years of age, was diagnosed with partial seizures and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: cardiac failure acute. GABAPEN dosage: DAILY DOSE:600MG. During the same period patient was treated with ANAFRANIL, LUVOX, DEPAKENE, RISPERDAL. Patient died on 12/01/2006.
Gabapen Side Effects Report #5195254-0
GABAPEN problem was reported by a Physician from JAPAN on Nov 06, 2006. Male patient, 55 years of age, was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: epilepsy, somnolence. GABAPEN dosage: DAILY DOSE:900MG. During the same period patient was treated with RIVOTRIL, CLOBAZAM, DIAMOX, ALEVIATIN. Patient recovered.
Gabapen Side Effects Report #5195288-6
Physician from JAPAN reported GABAPEN problem on Dec 06, 2006. Male patient, weighting 44.09 lb, was diagnosed with epilepsy, dyskinesia, sleep disorder, asthma and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest. GABAPEN dosage: unknown. During the same period patient was treated with ALEVIATIN, CLOBAZAM, EPILEO PETIT MAL, HALOPERIDOL, CYANOCOBALAMIN, QVAR. Patient recovered.
Gabapen Side Effects Report #5381161-7
GABAPEN problem was reported by a Physician from JAPAN on June 25, 2007. Male patient, weighting 30.86 lb, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal, nasopharyngitis, pyrexia, somnolence, status epilepticus. GABAPEN dosage: DAILY DOSE:560MG-TEXT:15MG/KG. During the same period patient was treated with EXCEGRAN, CLOBAZAM. Patient was hospitalized. Patient recovered.
Gabapen Side Effects Report #5382278-3
Physician from JAPAN reported GABAPEN problem on June 22, 2007. Female patient, weighting 196.2 lb, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour. GABAPEN dosage: DAILY DOSE:800MG. During the same period patient was treated with HYDANTOL, DEPAKENE, RIVOTRIL, PRIMIDONE, DIAMOX. Patient recovered.
Gabapen Side Effects Report #5384653-X
GABAPEN problem was reported by a Physician from JAPAN on July 03, 2007. Male patient, weighting 94.80 lb, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, miosis. GABAPEN dosage: unknown. During the same period patient was treated with DEPAKENE, EXCEGRAN, CLOBAZAM. Patient was hospitalized. Patient recovered.
Gabapen Side Effects Report #5392757-0
Physician from JAPAN reported GABAPEN problem on July 09, 2007. Male patient, weighting 94.80 lb, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, miosis. GABAPEN dosage: unknown. During the same period patient was treated with DEPAKENE, EXCEGRAN, CLOBAZAM. Patient was hospitalized. Patient recovered.
Gabapen Side Effects Report #5392804-6
GABAPEN problem was reported by a Physician from JAPAN on July 09, 2007. Male patient, weighting 123.5 lb, was diagnosed with epilepsy, pyrexia and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: dialysis, eosinophil count increased, pyrexia, renal failure acute. GABAPEN dosage: unknown. During the same period patient was treated with ROCEPHIN, LOXONIN, TEGRETOL, PHENOBARBITAL, DEPAKENE, SOLANAX, TERNELIN, TRYPTANOL. Patient was hospitalized and became disabled. Patient recovered.
Gabapen Side Effects Report #5392911-8
Physician from JAPAN reported GABAPEN problem on July 11, 2007. Male patient, 50 years of age, was diagnosed with convulsion and was treated with GABAPEN. GABAPEN dosage: DAILY DOSE:1200MG. During the same period patient was treated with TEGRETOL. Patient died on 07/01/2007.
Gabapen Side Effects Report #5405485-X
GABAPEN problem was reported by a Physician from JAPAN on July 23, 2007. Male patient, weighting 123.5 lb, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: agitation, faeces discoloured, hypertension, hyperthermia, incontinence, somnolence, suicide attempt. GABAPEN dosage: DAILY DOSE:1600MG. During the same period patient was treated with TEGRETOL, CHARCOAL, VALPROATE, CLONAZEPAM, DIOVAN, NORVASC, ALOSENN. Patient recovered.
Gabapen Side Effects Report #5406594-1
Physician from JAPAN reported GABAPEN problem on July 25, 2007. Male patient was diagnosed with convulsion and was treated with GABAPEN. GABAPEN dosage: DAILY DOSE:1200MG. During the same period patient was treated with TEGRETOL. Patient died on 07/10/2007.
Gabapen Side Effects Report #5419002-1
GABAPEN problem was reported by a Physician from JAPAN on Aug 07, 2007. Male patient, 48 years of age, was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: fall, somnolence. GABAPEN dosage: DAILY DOSE:1200MG. During the same period patient was treated with HYDANTOL, DIAZEPAM, EPIRENAT. Patient recovered.
Gabapen Side Effects Report #5419021-5
Pharmacist from JAPAN reported GABAPEN problem on Aug 07, 2007. Male patient, 53 years of age, was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: dysphagia, tongue disorder, tongue paralysis. GABAPEN dosage: DAILY DOSE:1600MG. During the same period patient was treated with ALEVIATIN, SELENICA. Patient recovered.
Gabapen Side Effects Report #5422666-X
GABAPEN problem was reported by a Pharmacist from JAPAN on Aug 10, 2007. Female patient, 36 years of age, was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: platelet count decreased, white blood cell count decreased. GABAPEN dosage: DAILY DOSE:1200MG. During the same period patient was treated with ZONISAMIDE, LEUCON. Patient recovered.
Gabapen Side Effects Report #5441125-1
Pharmacist from JAPAN reported GABAPEN problem on Aug 20, 2007. Male patient, 53 years of age, was diagnosed with epilepsy and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: dysphagia, movement disorder, tongue disorder. GABAPEN dosage: DAILY DOSE:1200MG. During the same period patient was treated with PHENYTOIN CAP, SELENICA. Patient recovered.
Gabapen Side Effects Report #5441127-5
GABAPEN problem was reported by a Physician from JAPAN on Aug 21, 2007. Male patient, 48 years of age, was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: fall, loss of consciousness, somnolence. GABAPEN dosage: DAILY DOSE:1200MG. During the same period patient was treated with HYDANTOL, DIAZEPAM, EPIRENAT. Patient recovered.
Gabapen Side Effects Report #5441160-3
Physician from JAPAN reported GABAPEN problem on Aug 20, 2007. Male patient, 63 years of age, was diagnosed with pain and was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: neutrophil count decreased, white blood cell count decreased. GABAPEN dosage: DAILY DOSE:1800MG. During the same period patient was treated with TEGRETOL. Patient was hospitalized. Patient recovered.
Gabapen Side Effects Report #5443924-9
GABAPEN problem was reported by a Consumer or non-health professional from JAPAN on Aug 24, 2007. Male patient, 30 years of age, was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: coma, convulsion, intentional overdose, mydriasis, suicide attempt. GABAPEN dosage: unknown. Patient recovered.
Gabapen Side Effects Report #5446648-7
Pharmacist from JAPAN reported GABAPEN problem on Aug 10, 2007. Female patient, 36 years of age, was treated with GABAPEN. After drug was administered, patient experienced the following problems/side effects: platelet count decreased, white blood cell count decreased. GABAPEN dosage: DAILY DOSE:1200MG. During the same period patient was treated with ZONISAMIDE, LEUCON. Patient recovered.
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Drug Information: Gabapentin
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a694007.html
(ga' ba pen tin)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. |
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.
Gabapentin is used to help control certain types of seizures in patients who have epilepsy. Gabapentin is also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Gabapentin is in a class of medications called anticonvulsants. Gabapentin treats seizures by decreasing abnormal excitement in the brain. Gabapentin relieves the pain of PHN by changing the way the body senses pain.
How should this medicine be used?
Gabapentin comes as a capsule, a tablet, and an oral solution (liquid) to take by mouth. It is usually taken with a full glass of water (8 oz) three times a day. Gabapentin may be taken with or without food. Take this medication at evenly spaced times throughout the day and night; do not let more than 12 hours pass between doses. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take gabapentin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If your doctor tells you to take one-half of a tablet as part of your dose, carefully split the tablet along the score mark. Use the other half-tablet as part of your next dose. Properly throw away any half-tablets that you have not used within several days of breaking them.
Your doctor will probably start you on a low dose of gabapentin and gradually increase your dose as needed to treat your condition. If you are taking gabapentin to treat PHN, tell your doctor if your symptoms do not improve during your treatment.
Gabapentin may help to control your condition but will not cure it. Continue to take gabapentin even if you feel well. Do not stop taking gabapentin without talking to your doctor. If you suddenly stop taking gabapentin, you may experience withdrawal symptoms such as anxiety, difficulty falling asleep or staying asleep, nausea, pain, and sweating. If you are taking gabapentin to treat seizures and you suddenly stop taking the medication, you may experience seizures more often. Your doctor probably will decrease your dose gradually over at least a week.
Other uses for this medicine
Gabapentin is also sometimes used to relieve the pain of diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes), and to treat and prevent hot flashes (sudden strong feelings of heat and sweating) in women who are being treated for breast cancer or who have experienced menopause ( 'change of life', the end of monthly menstrual periods). Talk to your doctor about the risks of using this medication for your condition.
This medication may 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 gabapentin,
- tell your doctor and pharmacist if you are allergic to gabapentin, any other medications, or any of the inactive ingredients in the type of gabapentin you plan to take. Ask your pharmacist for a list of the inactive ingredients.
- 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: hydrocodone (in Hydrocet, in Vicodin, others), morphine (Avinza, Kadian, MSIR, others), and naproxen (Aleve, Anaprox, Naprosyn, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking antacids such as Maalox or Mylanta, take them at least 2 hours before you take gabapentin.
- tell your doctor if you have or have ever had kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking gabapentin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking gabapentin.
- you should know that this medication may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
- if you are giving gabapentin to your child, you should know that your child's behavior and mental abilities may change while he or she is taking gabapentin. Your child may have sudden changes in mood, become hostile or hyperactive, have difficulty concentrating or paying attention, or be drowsy or clumsy. Have your child avoid activities that could be dangerous, such as riding a bicycle, until you know how gabapentin affects him or her.
- 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.
Gabapentin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- tiredness or weakness
- dizziness
- headache
- shaking of a part of your body that you cannot control
- double or blurred vision
- unsteadiness
- anxiety
- memory problems
- strange or unusual thoughts
- unwanted eye movements
- nausea
- vomiting
- heartburn
- diarrhea
- dry mouth
- constipation
- weight gain
- swelling of the hands, feet, ankles, or lower legs
- back or joint pain
- fever
- runny nose, sneezing, cough, sore throat, or flu-like symptoms
- ear pain
- red, itchy eyes (sometimes with swelling or discharge)
Some side effects may be serious. If you experience any of the following symptoms, call your doctor immediately:
- rash
- itching
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- hoarseness
- difficulty swallowing or breathing
- seizures
Gabapentin 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 the tablets and capsules at room temperature, away from excess heat and moisture (not in the bathroom). Store the oral solution in the refrigerator. 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:
- double vision
- slurred speech
- drowsiness
- diarrhea
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.
Keep all appointments with your doctor.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking gabapentin.
If you use a dipstick to test your urine for protein, ask your doctor which product you should use while taking this medication.
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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