-- Scott Roberts
FRIDAY, Oct. 25 (HealthDay News) -- Vizamyl (flutemetamol F 18
injection) has been approved by the U.S. Food and Drug
Administration for use with positron emission tomography (PET)
imaging of the brain to screen adults for signs of Alzheimer's
disease and other forms of dementia.
Dementia -- characterized by deteriorating memory, judgment,
language and motor skills -- has been associated with brain
accumulation of a protein called beta amyloid. Vizamyl, combined
with a PET scan, can help doctors detect this protein, the FDA said
Friday in a news release.
Vizamyl, the second diagnostic drug approved for this purpose,
was evaluated in clinical studies of 761 people. The injected drug
is not meant to predict whether a person will go on to develop
Alzheimer's or other types of dementia, or to evaluate how people
may respond to dementia therapies, the FDA warned.
Potential side effects of the drug include allergic-like
reaction, becoming flushed, headache, a rise in blood pressure,
nausea and dizziness, the agency said.
Vizamyl is produced for GE Healthcare by Medi-Physics Inc.,
based in Arlington Heights, Ill.
The FDA has more about
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