FDA approves second brain imaging drug for Alzheimer's patients
Vizamyl, a radioactive diagnostic drug, was approved by the Food and Drug Administration on Friday.
The drug, also known as flutemetamol F 18 injection, is used with positron emission tomography imaging for adults being evaluation for Alzheimer's disease and dementia.
Vizamyl attaches to beta amyloid and produces a PET image of the brain. Little to no beta amyloid accumulation in the brain means the cause of the dementia is probably not due to Alzheimer's, whereas a positive scan means it is more likely.
The drug is considered another tool for physicians to evaluate whether a person has dementia or Alzheimer's disease. It is the second diagnostic drug for visualizing beta amyloid, as the FDA approved Amyvid (Florbetapir F 18 injection) in 2012.
Common side effects associated with the drug include flushing, headache, increased blood pressure, nausea and dizziness, the FDA said.
GE Healthcare by Medi-Physics Inc. is manufacturing Vizamyl.