FDA Issues Alert on Paxil

Originally posted at www.fda.gov

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 Paxil, 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 Paxil 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.