Frova (Frovatriptan Succinate) - FDA Alerts

FDA Alerts related to Frova (Frovatriptan)

FDA ALERT [7/2006] – Possible Life-Threatening  Threatening Serotonin Syndrome When Used With SSRI or SNRI Medicines

A life-threatening condition called serotonin syndrome can happen when medicines called 5-hydroxytryptamine receptor agonists (triptans), such as Frova, and medicines used to treat depression and mood disorders called selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephrine reuptake inhibitors (SNRIs), are used together.  Signs and symptoms of serotonin syndrome include the following:

• restlessness
• hallucinations
• loss of coordination
• fast heart beat
• 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 a triptan, SSRI, or SNRI.  This information comes from reports sent to FDA and knowledge of how these medicines work.  If you take medicines for depression or mood disorders, ask your healthcare professional if your medicine is an SSRI or SNRI.

Before you take Frova and an SSRI or SNRI 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.