Prozac (fluoxetine)
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 Prozac®, 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 Prozac® 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 Prozac® 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 Prozac® 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
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
Brand/Generic Names
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Brand Names: Prozac®, Prozac-Weekly®, Sarafem®, Rapiflux®
Capsules: 10 mg, 20 mg, 40 mg
Delayed Release Capsule: 90 mg
Tablets:10 mg, 20 mg, 40 mg
Pulvules: 10 mg, 20 mg, 40 mg
Oral solution: 20mg/5mL
What is Prozac® and what does it treat?
Fluoxetine is an antidepressant medication that works in the brain. It belongs to a class of medication known as selective serotonin reuptake inhibitor (SSRI) antidepressants. Fluoxetine is approved for the treatment of Major Depressive Disorder (MDD) in adults and children/adolescents aged 8-18 as well as Obsessive Compulsive Disorder (OCD), in adults and children/adolescents aged 7-17. Fluoxetine is also approved for the treatment of Panic Disorder, Bulimia Nervosa and Premenstrual Dysphoric Disorder (PMDD) in adults.
Major Depression occurs when a person experiences at least five symptoms of depression, one of which must be either sad or depressed mood, or loss of interest in most activities. Other symptoms include changes in sleep (usually poor sleep); changes in appetite (usually decreased); loss of energy; feeling worthless/guilty/ hopeless/ helpless; psychomotor agitation or retardation (i.e. thoughts/movements speeding up or slowing down); difficulty concentrating; and thoughts of death (suicidal thinking). These symptoms must be present for a minimum of two weeks to satisfy the diagnosis of MDD.
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).
Panic Disorder occurs when a person experiences unexpected and repeated episodes of intense fear along with physical symptoms including chest pain, shortness of breath, heart palpitations, sweating, dizziness, and nausea.
Bulimia Nervosa is an eating disorder in which a person eats large amounts of food in a short amount of time (binges) and tries to prevent weight gain by “purging” (e.g. vomiting or using laxatives). This occurs multiple times per week for at least 3 months.
PMDD occurs when a woman experiences symptoms including irritability, mood changes, bloating, tension, breast tenderness and sadness in association with the menstrual cycle.
What is the most important information I should know about Prozac®?
After starting fluoxetine, symptoms gradually decrease over a period of weeks. Sleep and other physical symptoms may improve before there is noticeable improvement in mood or interest in activities. Once symptoms are under control, MDD and other disorders fluoxetine is used to treat usually require long-term treatment to help prevent the return of symptoms. Only your healthcare provider can determine the length of fluoxetine treatment that is right for you.
Do not stop taking fluoxetine or change your dose without talking to with your healthcare provider first.
Stopping fluoxetine 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).
Because depression is also a part of Bipolar illness, people who take antidepressants may be at risk for "switching" from depression into mania. 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 Prozac® and pregnancy?
If you are pregnant or are planning to become pregnant, it is very important to discuss the risks and benefits of taking fluoxetine with your provider. The FDA has classified fluoxetine 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 fluoxetine 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 taking their antidepressant after learning of a pregnancy are five times more likely to relapse into depression than pregnant women who continue their antidepressants. 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 fluoxetine) will pass into the breast milk. The concentrations in breast milk are generally quite low with fluoxetine 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 Prozac®?
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The most bothersome symptoms of your condition and how often these have occurred in the past
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If you have thoughts of suicide
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Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
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Any medical problems or medication allergies you have
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All other medications and nutritional/herbal supplements you are currently taking
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If you are pregnant, plan to become pregnant, or are breast-feeding
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Use of alcohol or recreational drugs (if applicable)
How should I take Prozac®?
Fluoxetine is usually taken once daily with or without food.
While the dose usually ranges from 20 mg to 80 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 Prozac®?
If you miss a dose of fluoxetine, 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 Prozac®?
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 Prozac®?
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 Prozac®?
Common: Side effects with fluoxetine are generally mild and similar to those reported with other SSRI antidepressants. The most commonly reported side effects are nausea, vomiting, diarrhea, headache, insomnia, nervousness, restlessness, tremors, sweating, sleepiness, dry mouth, fatigue, weight loss or gain, dizziness and restlessness. If you experience side effects after starting fluoxetine, 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 occur infrequently with fluoxetine include low sodium blood levels (signs may include, headache, weakness, difficult concentrating and remembering), acute abdominal pain, high or low blood pressure, abnormal heart rate, increased frequency of urination, increased bleeding (e.g. gums may bleed more easily) blurred vision, seizure, restlessness, muscle stiffness and teeth grinding.
Are there any risks for taking Prozac® for long periods of time?
To date, there are no known neurotoxic or permanent side effects associated with long term use of fluoxetine. It is a safe and effective medication when used as directed.
What other drugs may interact with Prozac®?
Fluoxetine should not be taken with or within two weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®) and selegeline (Emsam®).
Although rare, there is an increased risk of serotonin syndrome when fluoxetine is used with other medications that increase serotonin 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 fluoxetine to increase the concentrations of the following medications in your body: atomoxetine, aripiprazole, phenytoin, carbamazepine, haloperidol, clozapine, alprazolam, diazepam, warfarin, imipramine, desipramine, and other tricyclic antidepressants. Doses may need to be adjusted when starting fluoxetine.
Thioridazine (Mellaril®) should not be taken in combination with fluoxetine.
Patients receiving warfarin therapy should be carefully monitored when fluoxetine is initiated or discontinued. Changes in bloodwork as well as increased bleeding have been reported when fluoxetine 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 Prozac® to work?
Disturbances in sleep, energy, or appetite may show some improvement within the first 1-2 weeks and can be an important early signal that the medication is working. Other symptoms such as depressed mood or lack of interest in activities may take 4-6 weeks before improvement is evident.
Like other medications used for anxiety disorders (e.g. panic disorder and OCD) fluoxetine may take several weeks before it is fully effective. It is important to give the medication sufficient time before judging whether or not it will work for a given person.
Updated by
Wilfred W. Acholonu, Jr., Pharm.D., BCPP
(February 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 further information please contact the pharmaceutical company listed below.
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Eli Lilly and Company
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Lilly Corporate Center
Indianapolis, IN 46285
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800-545-5979
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www.lilly.com
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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.
Prozac Rx Assistance Program: 1-800-545-6962
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