"Jan. 29, 2013 -- Older women with heart problems may be at greater risk for mental changes that are thought to signal the beginnings of a type of dementia, a new study shows.
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Miraluma Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Miraluma FDA Prescribing Information: Side Effects
Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patient's genders were not recorded) were in cardiac clinical trials and 673 (100% women) in breast imaging trials. Cases of angina, chest pain, and death have occurred (see WARNINGS AND PRECAUTIONS). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table:
Table 2.0 - Selected Adverse Events Reported in > 0.5%
of Patients Who Received Technetium Tc99m Sestamibi in Either Breast or Cardiac
|Body System||Breast Studies||Cardiac Studies|
n = 673
n = 685
n = 2361
n = 3046
|Body as a Whole||21 (3.1%)||6 (0.9%)||17 (0.7%)||23 (0.8%)|
|Headache||11 (1.6%)||2 (0.3%)||4 (0.2%)||6 (0.2%)|
|Cardiovascular||9 (1.3%)||24 (3.5%)||75 (3.2%)||99 (3.3%)|
|Chest Pain/Angina||0 (0%)||18 (2.6%)||46 (1.9%)||64 (2.1%)|
|ST segment changes||0 (0%)||11 (1.6%)||29 (1.2%)||40 (1.3%)|
|Digestive System||8 (1.2%)||4 (0.6%)||9 (0.4%)||13 (0.4%)|
|Nausea||4 (0.6%)||1 (0.1%)||2 (0.1%)||3 (0.1%)|
|Special Senses||132 (19.6%)||62 (9.1%)||160 (6.8%)||222 (7.3%)|
|Taste Perversion||129 (19.2%)||60 (8.8%)||157 (6.6%)||217 (7.1%)|
|Parosmia||8 (1.2%)||6 (0.9%)||10 (0.4%)||16 (0.5%)|
|*Excludes the 22 patients whose gender were not recorded.|
In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients. In 11 of these patients the pain appears to be associated with biopsy/surgical procedures.
The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrhythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritus, rash, urticaria and fatigue have also been attributed to administration of the agent.
Read the entire FDA prescribing information for Miraluma (Technetium Tc99m sestamibi) »
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