A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Optison Side Effects, and Drug Interactions - Perflutren
Optison Side Effects, and Drug Interactions - Perflutren
SIDE EFFECTS
OPTISON was administered in clinical studies in 279 patients.
Of these patients there were 192 (68.8%) men and 87 (31.2%) women. The racial
demographics were 199 (71.3%) Caucasian, 52 (18.6%) Black, 24 (8.6%) Hispanic,
and 4 (1.4%) other racial or ethnic groups.
In these patients, 47 (16.8%) reported at least one adverse
event. Of these one event was serious and required treatment with antihistamines
for hypersensitivity manifestations of dizziness, nausea, flushing and temperature
elevation. Deaths were not reported during the clinical studies.
Of the reported adverse reactions following the use of OPTISON
the most frequently reported were headache (5.4%), nausea and/or vomiting (4.3%),
warm sensation or flushing (3.6%), and dizziness (2.5%). The most common adverse
events observed in clinical studies of OPTISON are given in Table 4.
|
Table 4 SELECTED ADVERSE EVENTS REPORTED IN ³0.5%
OF THE SUBJECTS WHO RECEIVED OPTISON™ IN CONTROLLED CLINICAL
STUDIES (1)(2)
|
|
No. of Patients Exposed to OPTISON™
|
279
|
|
|
No. of Patients Reporting on Adverse Event
|
47
|
(16.8%)
|
|
Body as a Whole
|
38
|
(13.6%)
|
|
Headache
|
15
|
(5.4%)
|
|
Warm Sensation/Flushing
|
10
|
(3.6%)
|
|
Chills/fever
|
4
|
(1.4%)
|
|
Flu-like Symptoms
|
3
|
(1.1%)
|
|
Malaise/Weakness/Fatigue
|
3
|
(1.1%)
|
|
Cardiovascular System
|
12
|
(4.3%)
|
|
Dizziness
|
7
|
(2.5%)
|
|
Chest Pain
|
3
|
(1.1%)
|
|
Digestive System
|
12
|
(4.3%)
|
|
Nausea and/or Vomiting
|
12
|
(4.3%)
|
|
Nervous System
|
3
|
(1.1%)
|
|
Respiratory System
|
5
|
(1.8%)
|
|
Dyspnea
|
3
|
(1.1%)
|
|
Skin & Appendages
|
11
|
(3.9%)
|
|
Injection Site Discomfort
|
3
|
(1.1%)
|
|
Erythema
|
2
|
(0.7%)
|
|
Special Senses
|
9
|
(3.2%)
|
|
Altered Taste
|
5
|
(1.8%)
|
|
(1) Patients are counted separately within each body
system.
|
|
(2) The body system is reported if the aggregate is ³0.5%.
Details are not shown if the subsystem is not ³0.5%.
|
Adverse events reported in < 0.5% of subjects who received
OPTISON included: arthralgia, back pain, body or muscle aches, induration, urticaria,
dry mouth, eosinophilia, palpitations, paresthesia, photophobia, premature ventricular
contraction, pruritus, rash, irritableness, hypersensitivity, tinnitus, tremor,
visual blurring, wheezing, oxygen saturation decline due to coughing, discoloration
at the Heplock site, and burning sensation in the eyes.
Overall the reported adverse events with OPTISON were similar
in type and frequency to those reported in the 199 patients who received ALBUNEX®.
In the clinical dose ranging studies of 40 normal volunteers,
doses higher than those recommended in the Dosage and Administration section
tended to be associated with an increased frequency of reported adverse events.
DRUG INTERACTIONS
No information available.
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