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Olanzapine Fluoxetine (marketed as Symbyax) Information

Olanzapine/Fluoxetine (marketed as Symbyax) Information

FDA Alerts:

Persistent Pulmonary Hypertension [issued 7/2006]
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) were recently published in a medical journal...  More about this FDA Alert
 
SSRIs/SNRI/Triptan and Serotonin Syndrome [issued 7/2006]
A life-threatening condition called serotonin syndrome can happen when medicines called selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, one of the medicines in Symbyax, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are used together...  More about this FDA Alert

This information reflects FDA?s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.

Symbyax Information

FDA Alerts and Related Information

Persistent Pulmonary Hypertension (7/2006)
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) were 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 Symbyax belongs to,
  • 20 weeks or later in their pregnancies,
  • had a higher chance (were 6 times as likely) to have persistent pulmonary hypertension (PPHN),
  • than babies born to mothers who did not take antidepressants during pregnancy.
     
  • Healthcare Professional Sheet with FDA Alert  [HTML] [PDF]
  • Public Health Advisory: SSRIs and Persistent Pulmonary Hypertension (7/2006)

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SSRIs/SNRI/Triptan and Serotonin Syndrome (7/2006)
A life-threatening condition called serotonin syndrome (serious changes in how your brain, muscles and digestive system work due to high levels of serotonin in the body) can happen when medicines called selective serotonin reuptake inhibitors (SSRIs), such as Symbyax, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are used together. Signs and symptoms of serotonin syndrome include the following:

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

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. This information comes from reports sent to FDA and knowledge of how these medicines work. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

Before you take Symbyax 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.

Report Adverse Events to MedWatch  


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