Luvox Side Effects
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Luvox Safety Reports reported to FDA
Total Luvox reports: 3.Luvox FDA safety alerts: 2003 2004 2005 2007 .
Reported hospitalizations: 2.
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Reported Luvox Side Effects: delirium, sleep talking, self mutilation, hallucination, eating disorder, confusional state, amnesia, agitation, accidental overdose.
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Luvox Side Effects Report #5370682-9
Physician from JAPAN reported LUVOX problem on June 19, 2007. Female patient, 80 years of age, was diagnosed with insomnia and was treated with LUVOX. After drug was administered, patient experienced the following problems/side effects: delirium. LUVOX dosage: unknown. During the same period patient was treated with ZOLPIDEM. Patient was hospitalized. Patient recovered.
Luvox Side Effects Report #5374940-3
LUVOX problem was reported by a Physician from JAPAN on June 19, 2007. Female patient, 88 years of age, was diagnosed with depression, cerebral infarction, hyperlipidaemia, reflux oesophagitis, cardiac failure, hypertension and was treated with LUVOX. After drug was administered, patient experienced the following problems/side effects: delirium. LUVOX dosage: 25 MG. During the same period patient was treated with ASPIRIN, LOCHOL, PARIET, DIGOSIN, LUPRAC, ARTIST, MICARDIS, CALBLOCK. Patient was hospitalized. Patient recovered.
Luvox Side Effects Report #5380942-3
Health Professional from AUSTRALIA reported LUVOX problem on June 27, 2007. Female patient was treated with LUVOX. After drug was administered, patient experienced the following problems/side effects: accidental overdose, agitation, amnesia, confusional state, eating disorder, hallucination, self mutilation, sleep talking. LUVOX dosage: 300 MG. During the same period patient was treated with LAMICTAL, ZOLPIDEM TARTRATE. Patient recovered.
Drug Information: Fluvoxamine
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a695004.html
(floo vox' a meen)IMPORTANT WARNING:
| A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as fluvoxamine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant.You should know that your mental health may change in unexpected ways when you take fluvoxamine or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.Your healthcare provider will want to see you often while you are taking fluvoxamine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluvoxamine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf.No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you. |
Why is this medication prescribed?
Fluvoxamine is used to treat obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over). Fluvoxamine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs).
How should this medicine be used?
Fluvoxamine comes as a tablet to take by mouth. It usually is taken either once daily at bedtime or twice daily, once in the morning and once at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluvoxamine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
It may take several weeks or longer for you to feel the full benefit of fluvoxamine. Continue to take fluvoxamine even if you feel well. Do not stop taking fluvoxamine without talking to your doctor. Your doctor probably will decrease your dose gradually.
Other uses for this medicine
Fluvoxamine is also used sometimes to treat depression. Talk with your doctor about the possible risks of using this medication for your condition.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking fluvoxamine,
- tell your doctor and pharmacist if you are allergic to fluvoxamine or any other medications.
- tell your doctor if you are taking alosetron (Lotronex), astemizole (Hismanal) (not available in the U.S.), cisapride (Propulsid) (not available in the U.S.), pimozide (Orap), terfenadine (Seldane) (not available in the U.S.); tizanidine (Zanaflex) or thioridazine. Your doctor will probably tell you not to take fluvoxamine.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and herbal products you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); buspirone (Buspar); carbamazepine (Tegretol); clozapine (Clozaril); cyclosporine (Neoral, Sandimmune); dextromethorphan (in cough medications); diazepam (Valium); diltiazem (Cardizem); diuretics ('water pills'); haloperidol (Haldol); heart medications; lithium; medications for depression; medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); methadone; midazolam (Versed); phenytoin (Dilantin); sibutramine (Meridia); theophylline (TheoDur); and triazolam (Halcion). Also tell your doctor if you are taking the following medications or if you have stopped taking them within the past 2 weeks: monoamine oxidase inhibitors (MAO inhibitors) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what nutritional supplements you are taking, especially products that contain St. John's wort and tryptophan.
- tell your doctor if you drink or have ever drunk large amounts of alcohol or have used street drugs or have overused prescription medications. Also tell your doctor if you have or have ever had seizures, or heart, kidney, adrenal, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking fluvoxamine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking fluvoxamine.
- you should know that this medication 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.
- tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
- plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Fluvoxamine may make your skin sensitive to sunlight.
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 your 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?
Fluvoxamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness
- dry mouth
- nausea
- headache
- diarrhea
- constipation
- indigestion
- nervousness
- uncontrollable shaking of a part of the body
- weakness
- abnormal ejaculation
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- rapid heartbeat
- sweating
- rash
- hives
- seizures
Fluvoxamine may cause other side effects. Call your doctor if you have any unusual problems while you are 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.
What other information should I know?
It is important to keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to fluvoxamine.
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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