Tiagabine Side Effects
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Tiagabine Safety Reports reported to FDA
Total Tiagabine reports: 2.Tiagabine FDA safety alerts: 2001 2005 2008 .
Reported deaths: 1 Reported hospitalizations: 1.
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Reported Tiagabine Side Effects: respiratory arrest, completed suicide, cardiac arrest, syncope vasovagal, head injury, epilepsy, constipation, blood magnesium decreased.
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Tiagabine Side Effects Report #5098692-X
Physician from UNITED STATES reported TIAGABINE problem on Aug 22, 2006. Female patient, 35 years of age, weighting 194.0 lb, was treated with TIAGABINE. After drug was administered, patient experienced the following problems/side effects: blood magnesium decreased, constipation, epilepsy, head injury, syncope vasovagal. TIAGABINE dosage: 8 MG DAILY ORAL. During the same period patient was treated with FERROUS SULPHATE, MAGNESIUM CITRATE. Patient was hospitalized. Patient recovered.
Tiagabine Side Effects Report #5159958-8
TIAGABINE problem was reported by a Health Professional from UNITED STATES on Nov 03, 2006. Female patient, 54 years of age, was treated with TIAGABINE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, completed suicide, respiratory arrest. TIAGABINE dosage: unknown. During the same period patient was treated with CYCLOBENZAPRINE, ESZOPICLONE. Patient died.
Drug Information: Tiagabine
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a698014.html
(ty ag' a been)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.
Tiagabine is used in combination with other medications to treat partial seizures (a type of epilepsy). Tiagabine is in a class of medications called anticonvulsants. It is not known exactly how tiagabine works, but it increases the amount of natural chemicals in the brain which prevent seizure activity.
How should this medicine be used?
Tiagabine comes as a tablet to take by mouth. It usually is taken with food two to four times a day . However, for the first week of treatment will only take tiagabine once a day. Your doctor will slowly increase your dose (not more often than once each week ) until you are at the dose of tiagabine you are to take regularly. To help you remember to take tiagabine, take it around the same time(s) 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 tiagabine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take tiagabine even if you feel well. Do not stop taking tiagabine without talking to your doctor .Abruptly stopping this medication can cause seizures.Your doctor will probably decrease your dose gradually.
Other uses for this medicine
Tiagabine 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 tiagabine,
- tell your doctor and pharmacist if you are allergic to tiagabine or any other medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); anticonvulsants such as carbamazepine (Tegretol), ethosuximide (Zarontin), gabapentin (Neurontin), lamotrigine (Lamictal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin, Phenytek), primidone (Mysoline), and valproic acid (Depakene, Depakote); anticholinesterases such as physostigmine (Antilirium), pyridostigmine (Mestinon, Regonol), and neostigmine (Prostigmin); antidepressants; antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); chloroquine sulfate (Aralen);clarithromycin (Biaxin, in Prevpac) ; contrast dyes used during radiology procedures (CAT scans, X-rays); cyclosporine (Neoral, Sandimmune); dexamethasone (Decadron, Dexpak); diazepam (Valium); dicloxacillin; diltiazem (Cardizem, Dilacor, Tiazac, others; erythromycin (E.E.S., E-Mycin, Erythrocin); furosemide (Lasix); griseofulvin (Fulvicin-U/F, Grifulvin V, Gris-PEG) ; isoniazid (INH, Laniazid, Nydrazid); imipenem-cilastatin (Primaxin); lovastatin (Altocor, Mevacor, in Advicor); medications to treat HIV infection including delavirdine (Rescriptor); efavirenz (Sustiva); nevirapine (Viramune); and ritonavir ( Norvir, in Kaletra); medications that may make you drowsy, such as cough, cold, and allergy products, medications for anxiety, muscle relaxants, pain medications, sedatives, sleeping pills, or tranquilizers; medications for mental illness; methocarbamol (Robaxin); mycophenolate mofetil (CellCept); penicillins; phenylbutazone (no longer available in the US);propranolol (Inderal, Inderide ); quinidine (Quinidex); quinolones such as cinoxacin (Cinobac) (no longer available in the US), ciprofloxacin (Cipro), enoxacin (Penetrex) (no longer available in the US), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxequin), nalidixic acid (NegGram)(no longer available in the US), norfloxacin (Noroxin), ofloxacin (Floxin), sparfloxacin (Zagam) and trovafloxacin/alatrofloxacin combination (Trovan) (no longer available in the US) ; rifabutin (Mycobutin );rifampin (Rifadin, Rifamate, Rimactane, others); stimulants such as caffeine-containing products and decongestants; tacrolimus (Prograf); triazolam (Halcion); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); warfarin (Coumadin); or zafirlukast (Accolate).
- tell your doctor what herbal products you are taking, especially St. John's wort
- tell your doctor if you have or have ever had a severe rash caused by taking a medication; status epilepticus (seizures following one another without a break); eye, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tiagabine, call your doctor immediately.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tiagabine.
- you should know that tiagabine may make you drowsy and may affect your ability to think clearly . Do not drive a car or operate machinery until you know how this drug will affect you.
- remember that alcohol may add to the drowsiness caused by this medication. Ask your doctor about the safe use of alcoholic beverages while you are taking tiagabine.
- you should know that seizures, including status epilepticus, have occurred in people without epilepsy who take tiagabine. These seizures usually occurred soon after beginning treatment with tiagabine or near the time of a dose increase, but also have also occurred at other times during treatment.
What special dietary instructions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medication.
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. If you have missed more than one dose, call your doctor for instructions about re-starting your medication.
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.
Tiagabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dizziness
- drowsiness
- lack of energyor weakness
- wobbliness, unsteadiness, or incoordination causing difficulty walking
- depression
- hostility or anger
- irritability
- confusion
- difficulty concentrating or paying attention
- abnormal thinking
- speech or language problems
- increased appetite
- upset stomach
- stomach pain
- nervousness
- difficulty falling asleep or staying asleep
- itching
- bruising
- painful or frequent urination
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- rash
- sores on the inside of your mouth, nose, eyes or throat
- flu-like symptoms
- changes in vision
- severe weakness
- shaking hands you cannot control
- numbness, pain, burning, or tingling in the hands or feet
- seizures, including status epilepticus
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:
- tiredness
- weakness
- wobbliness, unsteadiness, or incoordination causing difficulty walking
- shaking hands you cannot control
- confusion
- speech or language problems
- agitation
- anger or hostility
- depression
- vomiting
- loss of consciousness
- abnormal, uncontrollable muscle contractions
- temporary inability to move (paralysis)
- seizures, including status epilepticus
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 and the laboratory.
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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