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.
Report Adverse Events to
MedWatch
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Date created: May, 2005, updated May 2, 2007