Escitalopram
(marketed as Lexapro)
This is a summary of the most important
information about
Lexapro. For details, talk to your
healthcare professional.
FDA ALERT [07/2006] – Possible Life-Threatening
Serotonin Syndrome When Used With Triptan
Medicines
A life-threatening condition called serotonin
syndrome can happen when medicines called
selective serotonin
reuptake inhibitors (SSRIs), such as
Lexapro, 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 Lexapro 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.
This information reflects FDA’s current analysis
of data available to
FDA concerning
this drug. FDA intends to update this sheet when
additional information or analyses become available.
FDA ALERT [07/2006]
– Infant Persistent Pulmonary Hypertension
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 Luvox belongs to,
20 weeks or later in their
pregnancies, had a higher chance (were 6 times as
likely) to have persistent pulmonary hypertensio
(PPHN),
than babies born to mothers who did
not take antidepressants during pregnancy.
The FDA plans to
further look at the role of SSRIs in babies
with PPHN.
Talk to your
doctor if you are taking Lexapro and are
pregnant or are planning to have a baby. You and your doctor will need
to talk about the best way to treat your depression during pregnancy.
This information reflects FDA’s current analysis
of data available to
FDA concerning
this drug. FDA intends to update this sheet when
additional information or analyses become available.
Escitalopram
(marketed as Lexapro)
What is Lexapro?
Lexapro is in a
class of medicines called selective
serotonin reuptake inhibitors (SSRIs).
Lexapro tablets and oral
solution are used to treat:
·
Depression
·
Generalized Anxiety Disorder (GAD)
Never take Lexapro if you
are taking another drug used to treat depression, called a
Monoamine Oxidase
Inhibitor (MAOI), or if you have stopped
taking an MAOI in the last 14 days. Taking Lexapro close in time to an
MAOI can result in serious, sometimes fatal, reactions, including:
·
High body temperature
·
Coma
·
Seizures (convulsions)
MAOI drugs
include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate),
Marplan (isocarboxazid), and other brands.
What Are The Risks?
The following are the major potential risks and side
effects of Lexapro therapy. However, this list is not complete.
· Possible life-threatening serotonin
syndrome when used with triptan medicines: See FDA Alert [07/2006]
above.
· Infant persistent pulmonary
hypertension: See FDA Alert [07/2006] above.
· Stopping Lexapro:
Do not stop taking Lexapro suddenly because you
could get side effects. Your healthcare professional will slowly
decrease your dose.
§ Bleeding problems:
Lexapro may cause bleeding problems, especially if
taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such
as ibuprofen and naproxen), or other drugs that affect bleeding.
§ Mania:
You may become unusually hyperactive, excitable or elated.
§ Seizures:
You may experience a seizure (convulsion), even if
you are not taking Lexapro close in time with an MAOI.
· Pregnancy:
Tell your healthcare professional if you are or
may be pregnant (see FDA Alert [07/2006]
above). In addition to the issue described
in the alert, babies delivered to mothers taking Lexapro late in
pregnancy have developed problems, such as difficulty breathing and
feeding.
· Suicidal thoughts or actions:
Persons taking Lexapro may be more likely to think about
killing themselves or actually try to do
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Sexual problems: You
may have problems with impotence (erectile dysfunction), abnormal
ejaculation, difficulty reaching orgasm, or decreased libido (sexual
desire).
Escitalopram
(marketed as Lexapro)
· Other side effects
include difficulty sleeping, nausea, increased
sweating, fatigue, and sleepiness.
· Tell your healthcare professional
about all your medical conditions,
especially liver or kidney disease. Tell your healthcare professional if
you are breast-feeding or plan to breast-feed your baby.
Are There Any Interactions With Drugs
or
Foods?
· Do not take Lexapro with Celexa (citalopram),
another drug used to treat depression, because they are very similar and
you could get an overdose.
· Lexapro may
interact with medicines other than the ones already mentioned in this
information sheet. These interactions can cause serious side effects.
Tell your healthcare professional about
all medicines,
vitamins, and herbal supplements you take.
• If you plan to drink alcohol, talk to your
healthcare professional.
How Do I Take Lexapro?
Lexapro is taken by mouth, with or without food,
exactly as prescribed by your healthcare professional.
Is There Anything Else I need to Know?
You can get more information about antidepressants
at:
http://www.fda.gov/
Date this drug approved 2002 Patient Information
Sheet Revised 07/2005 Patient Information Sheet Revised 07/2006
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