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 Paxil 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)

 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 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.

• Healthcare Professional Sheet with FDA Alert [HTML] [PDF]
• Public Health Advisory: SSRIs/SNRI/Triptan and Serotonin Syndrome (7/2006)

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.