[Posted 12/14/2012] ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.
FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.
BACKGROUND: SSRIs are marketed under various brand and generic drug names, and are used to treat depression and other psychiatric disorders. There are no adequate and well-controlled studies of SSRIs in pregnant women.
PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.
RECOMMENDATION: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. See the Data Summary in the FDA Drug Safety Communication for additional information. FDA will communicate any new information on the risk of bleeding and dabigatran when it becomes available. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
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 24 years of age. 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 if 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/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.
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.
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) and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). Fluvoxamine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Fluvoxamine comes as a tablet and an extended-release capsule to take by mouth. The tablet usually is taken either once daily at bedtime or twice daily, once in the morning and once at bedtime. The extended-release capsule usually is taken, with or without food , once daily 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.
Swallow the extended-release capsules whole; do not be crush or chew them.
Your doctor may start you on a low dose of fluvoxamine and gradually increase your dose, not more often than once every week, depending on how well the medication works for you and the side effects you experience.
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. If you suddenly stop taking fluvoxamine, you may experience withdrawal symptoms such as irritability; agitation; dizziness; extreme worry; uneasiness; confusion; headache; tiredness; mood changes; difficulty falling asleep or staying asleep; or pain, burning, numbness, tingling or 'electric shock' sensations in the hands or feet. Your doctor probably will decrease your dose gradually.
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.
Unless your doctor tells you otherwise, continue your normal diet.
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.
drowsiness
difficulty concentrating, memory problems, or confusion
dry mouth
headache
nausea
vomiting
diarrhea
stomach pain
constipation
indigestion
gas
change in taste
decreased appetite
weight loss
nervousness
weakness
unsteadiness
changes in sex drive or ability
chest pain
problems with coordination
dizziness
hallucination (seeing things or hearing voices that do not exist)
fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
pain, burning, numbness, or tingling in the hands or feet
shaking of a part of the body that you cannot control
rash
hives
slowed or difficult breathing
seizures
loss of consciousness
unusual bleeding or bruising
bloody nose
vomiting blood or a material that looks like coffee grounds
red blood in stool or black and tarry stools
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/Safety/MedWatch] or by phone [1-800-332-1088].
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 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.
enlarged pupils (black circle in center of eye)
unsteadiness
dizziness
drowsiness
nausea
vomiting
diarrhea
difficulty breathing
changes in heartbeat
shaking of a part of the body that you cannot control
seizure
changes in alertness
loss of consciousness
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.
Last Revised - 02/15/2012
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.