Brain-Imaging Drug Vizamyl Approved for Alzheimer's Detection
FRIDAY, Oct. 25 -- 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 this approval.
Posted: October 2013