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Fluvoxamine

What is Fluvoxamine?

Fluvoxamine is in a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Fluvoxamine is a generic medicine used to treat obsessive-compulsive disorder (OCD).

Fluvoxamine FDA Alert - Serotonin Syndrome

In July 2006, the FDA issued an alert stating that a life-threatening condition called serotonin syndrome can occur when medicines called Selective Serotonin Reuptake Inhibitors (SSRIs, such as fluvoxamine) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together. Signs and symptoms of serotonin syndrome include:

  • restlessness
  • hallucinations
  • loss of coordination
  • fast heartbeat
  • increased body temperature
  • fast changes in blood pressure
  • overactive reflexes
  • diarrhea
  • coma
  • nausea
  • vomiting

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

Fluvoxamine FDA Alert - Antidepressants and Pregnant Women

In July 2006, the FDA issued an alert announcing the results of a study looking at the use of antidepressant medicines during pregnancy by mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies. Babies born with PPHN can be very sick and may die. Results from the study also showed that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies had a higher chance (were 6 times as likely) to have PPHN, when compared to babies born to mothers who did not take antidepressants during pregnancy.

The FDA has announced that it plans to further examine the role of SSRIs in babies with PPHN.

Talk to your healthcare professional if you are taking fluvoxamine and are pregnant, or are planning to become pregnant. You and your healthcare professional can decide the best way to treat your depression during pregnancy.

More information on antidepressants is available from the FDA here.

Fluvoxamine and the Increased Risk of Suicidality

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Click here for more information on this advisory.

In June 2005, the FDA issued a public health advisory announcing that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, such as fluvoxamine. The FDA highlighted that adults taking antidepressants (particularly those being treated for depression) should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment beings and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications. Click here for more information on this advisory.

Who Should Not Take Fluvoxamine?

Never take fluvoxamine while taking another drug that treats depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking these two drugs close in time can result in serious (and sometimes fatal) reactions including high body temperature, coma, and seizures (convulsions).

MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.

Fluvoxamine Health Risks

In addition to the health risks announced in the FDA alerts (above), there may be other dangers associated with fluvoxamine use.

Do not stop taking fluvoxamine suddenly. Doing so may result in harmful side effects. Your healthcare professional should slowly decrease your dose as necessary.

The risks of using fluvoxamine include:

  • An increased risk of having suicidal thoughts or actions
  • Bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding
  • Mania (becoming hyperactive, excitable, or elated)
  • Seizures (even if fluvoxamine is not taken close in time with a MAOI)
  • Increased risks if you are pregnant or may become pregnant. Babies born to mothers taking fluvoxamine late in pregnancy have developed problems such as difficulty breathing and feeding
  • Sexual problems including impotence (erectile dysfunction), abnormal ejaculation, difficulty in reaching orgasm, or decreased libido (sexual desire)

Other side effects of fluvoxamine use include:

  • Nausea
  • Vomiting
  • Upset stomach
  • Difficulty sleeping
  • Nervousness
  • Shakiness
  • Sweating
  • Weakness
  • Decreased appetite
  • Sleepiness

It is important to tell your healthcare professional about all known medical conditions, especially if you have liver or kidney disease, or glaucoma. Tell your healthcare professional if you breast-feed or are planning to breast-feed your baby.

Can Other Medicines or Food Affect Fluvoxamine?

In order to avoid dangerous interactions with any medicines you might be taking, tell your healthcare professional about all prescription and non-prescription medicines, vitamins, and herbal supplements that you take.

Medicines of special concern include:

  • Certain benzodiazepines, which treat anxiety
  • Mexitil (mexiletine), which treats heart beat problems
  • Theophylline, which treats asthma
  • Warfarin, which treats blood clots

If you plan to drink alcohol while taking fluvoxamine, talk to your healthcare professional.

Fluvoxamine - Getting Legal Help

While most medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions related to fluvoxamine use, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by fluvoxamine use.

  • Go here to learn more about an attorney's role in a pharmaceutical liability case.
  • To find an experienced attorney, use the "Find a Lawyer" tool on this page, or click here.
Next Steps
Contact a qualified product liability attorney to make sure
your rights are protected.
(e.g., Chicago, IL or 60611)

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