Fluvoxamine Defined

Fluvoxamine belongs to the class of medicines known as Selective Serotonin Reuptake Inhibitors or SSRIs which is used to treat obsessive-compulsive disorder or OCD.

FDA Alert on Fluvoxamine – Serotonin Syndrome

US Food and Drug Administration issued a warning in July 2006 about a life-threatening condition known as serotonin syndrome can happen when the medicines called Selective Serotonin Reuptake Inhibitors or SSRIs like fluvoxamine and medicines that are used to treat migraine headaches called as 5-hydroxytryptamine receptors agonists or simply called as triptans are taken simultaneously. The following are symptoms of serotonin syndrome:

• Hallucinations
• Restlessness
• Fast heartbeat
• Loss of coordination
• Overactive reflexes
• Fast changes in blood pressure
• Increase of body temperature
• Diarrhea
• Coma
• Nausea and vomiting

Serotonin syndrome tends to occur during the start or increase of dosage of SSRI or triptan medication. If you are taking migraine headache medicines, consult with your healthcare provider if your medicine is a triptan.

FDA Alert on Fluvoxamine – Antidepressants and Pregnant Women

FDA issued a warning alert in July 2006 stating that the results of a study conducted to review the use of antidepressant medicines during pregnancy by mothers of babies born with severe health condition known as persistent pulmonary hypertension of the newborn or PPHN.

The babies who are born with PPHN experience an abnormal flow of blood through the heart and lungs and as a result, these babies do not get sufficient oxygen to their bodies. Babies born with PPHN tend to be very ill and may even die. The results from the study also revealed that babies born to mothers who used SSRIs twenty weeks or later in their pregnancies tend to have greater risks to have PPHN, compared to the babies born to mothers who did not used antidepressants during their pregnancies.

FDA said that it is planning to review more the role of SSRIs in babies with PPHN.

Consult with your healthcare provider if you are using fluvoxamine and are pregnant, or are planning to be pregnant. You and your healthcare provider can discuss and decide for the best way to treat your depression during pregnancy period.

The Increased Risks of Suicidality and Fluvoxamine

FDA issued public health advisory in October 2004 asking all antidepressant drug manufacturers to modify their product labeling by including a boxed warning and expanded alert statements that give healthcare providers reports of increased risk of suicidality, a condition characterized by suicidal thinking and behavior, in children and adolescents who are treated with these medications.

FDA placed another public health advisory in June 2005 stating that many latest scientific publications expressed the potential of increased suicidal behavior in adults who are being treated with antidepressant medicines like fluvoxamine. FDA stressed those adults who are taking antidepressants must be watched and monitored closely for the possibility of worsening depression and increased suicidality tendencies. Watching these patients is vital when dosage are increased or reduced. FDA is working closely with antidepressant manufacturers to assess completely the chances of suicidality in adults who are being treated with these medications.

Who should refrain from taking Fluvoxamine?

Avoid taking fluvoxamine while taking other medicines for depression called Monoamine Oxidase Inhibitor or MAOI, or if you have discontinued taking MAOI within the last 14 days. Taking these two medicines close in time may result to severe and even fatal reactions such as increased body temperature, seizures or convulsions, and coma.

MAOI medicines brand names Nardil or phenelzine sulfate, Parnate or tranylcypromine sulfate, Marplan or isocarboxazid, and more.

Fluvoxamine Health Risks

Aside from health risks stipulated in the FDA warnings, there may be other hazards related with the use of Fluvoxamine.

When you suddenly stop using fluvoxamine may lead to adverse side effects. Your healthcare provider would gradually reduce your dosage as needed:

• Greater chances of having suicidal thoughts or behaviors
• Seizures, even if fluvoxamine is not taken close in time with MAOI
• Mania or becoming hyperactive, excited, or elated
• Bleeding problems, particularly if it is taken with aspirin, NSAIDs or nonsteroidal anti-inflammatory medicines such as ibuprofen or naproxen, or other medicines that can affect bleeding
• Sexual problems which includes impotence, also known as erectile dysfunction, abnormal ejaculation, difficulty in reaching orgasm, and reduced sexual desires
• Greater risks if you are pregnant or may become pregnant; babies born to mothers who are taking fluvoxamine during late in pregnancy developed problems like difficulty in breathing and feeding

Other side effects of fluvoxamine are as follows:

• Nausea and vomiting
• Shakiness
• Upset stomach
• Lowered appetite
• Nervousness
• Weakness
• Sleeping problems

It is also vital to inform your healthcare provider about all the medical conditions particularly if you have kidney or liver problems, or glaucoma. Also, inform your healthcare provider if you are breastfeeding or if you are planning to breastfeed your baby.

Can other medicines or food affect the use of fluvoxamine?

To prevent hazardous interactions with any of the medicines that you may be taking, inform your healthcare provider regarding all the prescription and non-prescription medicines, vitamins, and herbal supplements that you are taking.

Some medicines of special concern are:

• Some benzodiazepines for anxiety
• Mexitil or mexitiline which treat heart beat problems
• Theophylline which treats asthma
• Warfarin for blood clots

If you are planning to drink alcohol while taking fluvoxamine, discuss this with your healthcare provider.

Obtaining Legal Help

Since all medications have side effects, it is the responsibility of the drug manufacturer to produce products that are safe for human consumption and inform the medical sector and the general public of its potential health risks associated with the medicines. If the manufacturer fails to do so, they can be held legally liable when patients are injured as a consequence of insufficient warnings or for the dangerous nature of the medicines, under the legal theory known as “product liability.”

If you or any of your family members suffer from any of the symptoms associated with the use of fluvoxamine, you must contact first your doctor or your healthcare provider. Then, look for an experienced lawyer who can discuss with you your legal options to protect your right to remedy for any injury as a result of the use of fluvoxamine.