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Higher risk of heart and
brain adverse events for Asthma drug Omalizumab
Omalizumab is used to
treat patients 12 years and older with moderate to severe persistent asthma who
have a positive skin or blood test to year-round allergens in the air and whose
symptoms are not well-controlled by asthma medicines called inhaled
corticosteroids. Omalizumab has been shown to decrease the number of asthma
attacks in these patients. Asthma is a chronic disease that affects the airways
in the lungs and can cause serious trouble breathing, so it is important to
take all asthma medicines exactly as they are prescribed. It is also approved
for patients 12 years and older with chronic hives without a known cause―a
condition called chronic idiopathic urticaria or CIU―who continue to have hives
that are not controlled by H1 antihistamine treatment.
A 5-year observational cohort
study was conducted in patients 12 years of age and older with moderate to
severe persistent asthma and a positive skin test reaction to a perennial
aeroallergen. A review of a 5-year
safety study found a slightly higher rate of heart and brain blood vessel
problems occurred in patients being treated with omalizumab. The heart and
brain blood vessel problems included mini-strokes known as transient ischemic
attacks or TIAs; heart attacks; sudden, unexpected chest pain; high blood pressure
in the arteries of the lungs called pulmonary hypertension; and blood clots in
the lungs and veins.
Information for patients
•
Uncontrolled asthma can cause serious breathing
problems, so it is important to take all the medicines your health care professionals
prescribe exactly as they tell you.
•
Get emergency medical help if you have any of
these signs of an allergic
reaction: hives, rash; anxiety or fear; flushing (warmth, redness, or
tingly feeling); feeling like you might pass out; chest tightness, wheezing,
feeling short of breath, difficult breathing; fast or weak heartbeats; swelling
of your face, lips, tongue, or throat.
•
There is slightly increased risk of problems
involving blood vessels supplying the heart and brain.
•
There is a risk of potentially life-threatening
anaphylaxis after any dose of
Omalizumab
•
.Do not change or stop taking Omalizumab or any
of your other asthma medicines unless your health care professional tells you
to do so.
•
If you also use a steroid medication, do not
stop using the steroid suddenly or you may have unpleasant withdrawal symptoms.
Talk with your doctor if any of your asthma medications do not seem to work as
well in treating or preventing attacks.
•
You may also have an increased risk of becoming
infected with parasites (worms) if you live in or travel to areas where such
infections are common.
•
Report side effects from Omalizumab.
.
Information for health care
professionals
•
FDA has added information about the findings of
a slightly elevated risk of cardiovascular and cerebrovascular serious adverse
events in Omalizumab treated patients. There are also findings regarding a
potential risk of cancer related to the use of Omalizumab.
•
Periodically reassess the need for continued
therapy with Omalizumab based on the patient’s disease severity and level of
asthma control.
•
Do not give Omalizumab to a child younger than
12 years old.
•
The appropriate duration of therapy for chronic
idiopathic urticaria has not been evaluated. FDA review of safety studies
suggests a slightly increased risk of problems involving the heart and blood
vessels supplying the brain among patients being treated with the asthma drug
Omalizumab.
•
Inform patient of the signs and symptoms of
anaphylaxis and instruct patient to obtain immediate medical care should
symptoms develop.
•
Instruct patients receiving Omalizumab, not to
decrease the dose or stop taking the drug or any other asthma medicines unless
you instruct them to do otherwise.
Report
adverse events involving Omalizumab.
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