Luvox (fluvoxamine)
FDA ALERT [05/2007] Suicidal Thoughts or Actions in Children and Adults
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs.
In short-term studies, antidepressants increased the risk of suicidality in children, adolescents and young adults when compared to placebo. Taking antidepressants may increase suicidality in about 1 out of 50 people 18 years or younger. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.
Patients, their families and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or health care professional. All patients being treated with antidepressants for any indication should watch for and notify their health care provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
This information reflects the FDA’s current analysis of data available to FDA concerning this drug.
FDA ALERT [07/2006] – Potentially Life- Threatening Serotonin Syndrome When Used With Triptan Medicines
A life-threatening condition called serotonin syndrome can happen when medicines called selective serotonin reuptake inhibitors (SSRIs), such as Luvox®, and medicines used to treat migraine headaches known “triptans” (e.g. sumatriptan/ Imitrex®) are used together. Signs and symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhea, nausea, vomiting and coma.
Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. Before you take Luvox® and a triptan together, talk to your healthcare professional. If you must take these medicines together, be aware of the possibility of serotonin syndrome, and get medical care right away if you think serotonin syndrome is happening to you.
This information reflects the FDA’s current analysis of data available to FDA concerning this drug
FDA ALERT [07/2006] – Infant Persistent Pulmonary Hypertension
The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) was recently published in a medical journal. Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die.
The study results showed that babies born to mothers who took selective serotonin reuptake inhibitors (SSRIs), the family of medicines Luvox® belongs to, 20 weeks or later in their pregnancies had a higher chance (were 6 times as likely) to have PPHN than babies born to mothers who did not take antidepressants during pregnancy (6-12 per 1000 births versus 1-2 per 1000 births).
The FDA plans to further look at the role of SSRIs in babies with PPHN. Talk to your doctor if you are taking Luvox ® and are pregnant or are planning to have a baby. You and your doctor will need to talk about the best way to treat your depression during pregnancy.
This information reflects the FDA’s current analysis of data available to FDA concerning this drug
Brand and Generic Names
- Brand name = Luvox®, Luvox CR®
Tablets: No longer manufactured
Capsules (extended release): 100 mg, 150 mg
- Generic name = Fluvoxamine
Tablets (immediate release): 25 mg, 50 mg, 100 mg
What is Luvox® and what does it treat?
Fluvoxamine is a medication that works in the brain. It belongs to a class of medication known as selective serotonin reuptake inhibitor (SSRI) antidepressants. Fluvoxamine is FDA approved for the treatment of obsessive compulsive disorder (OCD) in adults and children/adolescents aged 8-17.
OCD occurs when a person experiences the following symptoms at the same time: obsessions (unwanted, recurrent and disturbing thoughts) and compulsions (repetitive, ritualized behaviors that the person feels driven to perform in order to lessen the anxiety produced by the obsessions).
Social Anxiety Disorder is an anxiety disorder in which a person experiences extreme fear in situations where they have to meet new people. The person may have physical symptoms in social situations (e.g. blushing, sweating, shaking, dry mouth, palpitations) and commonly tries to avoid social settings.
What is the most important information I should know about Luvox®?
After starting fluvoxamine, symptoms gradually decrease over a period of weeks. Most patients with OCD who have responded to fluvoxamine will need to stay on the medication for prolonged periods of time, often years, to avoid relapse. Studies have indicated that this is both safe and effective, but it is important to remain under the supervision of your physician for as long as you continue taking any medication.
Do not stop taking fluvoxamine or change your dose without talking to with your healthcare provider first.
Stopping fluvoxamine abruptly may result in one or more of the following withdrawal symptoms: irritability, nausea, dizziness, vomiting, nightmares, headache and paresthesias (prickling, tingling sensation on the skin).
Although fluvoxamine is not approved to treat depression, it is important to know that people who take antidepressants may be at risk for developing mania. The risk of mania is increased in patients with a personal or family history of Bipolar Disorder. Symptoms of mania include "high" or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (e.g. excessive buying sprees).
Are there specific concerns about Luvox® and pregnancy?
If you are pregnant or are planning to become pregnant, it is very important to discuss the risks and benefits of taking fluvoxamine with your provider. The FDA has classified fluvoxamine as Category C in regards to pregnancy risk. This means that there have not been well-controlled studies in humans examining safety or that animal studies have demonstrated adverse effects to the developing fetus.
The benefits of fluvoxamine in pregnancy may still be greater than the potential risks. For instance, if depression is left untreated during pregnancy, there is a high risk for poor prenatal care and premature delivery, and the babies may exhibit developmental delays in speech, intelligence, and socialization skills. Women who stop their antidepressants after learning of a pregnancy are five times more likely to relapse than pregnant women who continue their antidepressant. Women who suffer with depression during their pregnancy are much more likely to become depressed postpartum as well.
As the risk for relapse or worsening depressive symptoms varies greatly among women during pregnancy, the decision to treat with antidepressants must be made on an individual basis. This decision is best made following thoughtful discussion with a trusted and informed health professional.
Regarding breast-feeding, it is believed that virtually all antidepressants (including fluvoxamine) will pass into the breast milk. The concentrations in breast milk are generally quite low with fluvoxamine even at higher doses and it would not be expected to cause adverse effects in babies. However, breastfeeding mothers should monitor their infants for behavioral side effects and adequate growth.
What should I discuss with my healthcare provider before taking Luvox®?
- The most bothersome symptoms of your condition and how often these have occurred in the past
- If you have thoughts of suicide
- Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
- Any medical problems that you may have
- All other medications you are currently taking and any medication allergies you have
- If you are pregnant, plan to become pregnant, or are breast-feeding
- Use of alcohol or recreational drugs (if applicable)
How should I take Luvox®?
Immediate release fluvoxamine tablets are usually taken two times per day with or without food.
Extended release fluvoxamine capsules are usually taken once daily at bedtime. Swallow the capsule whole with plenty of fluids. Do not divide, cut, chew, crush, or place the capsules in water.
While the total daily dose usually ranges from 50 mg to 200 mg, your healthcare provider will determine the dose that is right for you based upon your response.
What happens if I miss a dose of Luvox®?
If you miss a dose of fluvoxamine, take it as soon as you remember unless it is close to when your next dose is due. If it is close to your next dose, wait until then to take the medication and skip the missed dose. Do not double your next dose or take more than your prescribed dose.
What should I avoid while taking Luvox®?
Avoid drinking alcohol or using illegal drugs while you are taking antidepressant medications because the beneficial effects of the medication may be decreased and adverse effects may be increased (e.g. sedation).
What happens if I overdose with Luvox®?
If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center (1-800-222-1222).
Symptoms of overdose include drowsiness, nausea, vomiting, abdominal pain, tremor, slow heart rate, and seizures. A specific antidote does not exist.
What are the possible side effects of Luvox®?
Common: Side effects with fluvoxamine are generally mild and are similar to those reported with other SSRI antidepressants. The most commonly reported side effects are nausea, diarrhea, anxiety, insomnia, headache, dry mouth, increased sweating, sleepiness, yawning, flatulence, tremor, weight loss or gain, dizziness. If you experience side effects after starting fluvoxamine they will often improve over the first week or two as you continue to take the medication. Sexual side effects such as problems with orgasm or ejaculatory delay may also occur, and often do not diminish over time.
Rare: Other side effects which may occur infrequently with fluvoxamine include increased heart rate, low blood pressure, increased salivation, irregular menstrual cycle, increased frequency of urination, changes in taste, increased liver enzymes, increased bleeding (e.g. gums may bleed more easily), low sodium, and teeth grinding.
Are there any risks for taking Luvox® for long periods of time?
To date, there are no known neurotoxic or permanent side effects associated with long term use of fluvoxamine. It is a safe and effective medication when used as directed.
What other drugs may interact with Luvox®?
Fluvoxamine should not be taken with or within two weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®) and selegiline (Emsam®).
Although rare, there is an increased risk of serotonin syndrome when fluvoxamine is used with other medications that increase serotonin activity such as other antidepressants; migraine medications called “triptans” (e.g. Imitrex®); the analgesics tramadol (Ultram®) or meperidine (Demerol®); and the antibiotic linezolid (Zyvox®).
There is a possibility for fluvoxamine to significantly increase the levels of the following drugs: warfarin, theophylline, carbamazepine, propranolol, metoprolol, alprazolam, diazepam, clozapine, olanzapine, mexiletine, omeprazole tricyclic antidepressants such as amitriptyline. Dosage adjustments should be considered if using any of these medications in combination with fluvoxamine.
Combining fluvoxamine with ramelteon (RozeremTM), tizanidine (ZanaflexTM), thioridazine, pimozide, or alosetron (LotronexTM) is not recommended.
Patients receiving warfarin therapy should be carefully monitored when fluvoxamine is initiated or discontinued. Changes in bloodwork as well as increased bleeding have been reported when fluvoxamine is co-administered with warfarin (Coumadin®), aspirin or pain relievers known as “NSAIDS” (Non-Steroidal Anti-inflammatory Agents).
Always let your doctor know what other prescription, over-the-counter, and herbal medications you are taking.
How long does it take for Luvox® to work?
Like most other medications used for OCD, fluvoxamine may take several weeks before it is fully effective. It is important to give the medication sufficient time before judging whether it will work for a given person.
Updated by
Joshana K. Goga, Pharm.D., BCPP
(May 2009)
NAMI wishes to thank the College of Psychiatric and Neurologic Pharmacists for producing this fact sheet.
Reviewed by Dr. Ken Duckworth, NAMI Medical Director
For more information please contact the pharmaceutical company listed below.
Patient Prescription Drug Assistance Programs
Free or low-cost medications provided by pharmaceutical companies
Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.
RX Assistance Program 1-800-256-8918
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