FDA Approves DaTscan

Release date: 1/15/2011

NPF Statement on the FDA DaTscan approval:

"We are very pleased that DaTscan has been approved for use in the United States.  There is considerable evidence supporting its use in diagnosing Parkinson's disease.  The UK's National Health Service investigated imaging in Parkinson's disease and reported the DaTscan methodology could possibly help differentiate parkinsonism as a side effect of medication and psychogenic parkinsonism from Parkinson's disease, which, if proven, would be very helpful in quickly getting people affected by this disease the best therapy for them.  We hope that researchers will explore this possibility.  This is not a routine test and patients currently diagnosed with PD and who have responded to therapy probably do not need this test.  Many newly diagnosed patients, if their condition is fairly typical and the diagnosis has been confirmed by an expert, probably also will not benefit from this test.  Most guidelines for PD recommend a consultation with a specialist for every patient and imaging only in cases where there is some question that can be answered by the test.  For those questionable cases, this is a powerful new tool."

—Peter Schmidt, PhD, Vice President of Programs, Chief Information Officer

Excerpt from the GE Healthcare press release:

FDA Approves DaTscan™ (Ioflupane I 123 Injection) For Visualization Of Dopamine Transporters In Patients With Suspected Parkinsonian Syndromes

January 15, 2011 — GE Healthcare announced the US Food and Drug Administration (FDA) has approved DaTscan™ (Ioflupane I 123 Injection), a radiopharmaceutical agent intended for use with single photon emission computed tomography (SPECT) imaging, for the detection of dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes (PS). The first FDA-approved diagnostic imaging agent to help physicians evaluate neurodegenerative movement disorders, such as idiopathic (of unknown cause) Parkinson's disease (PD), DaTscan may be used as an adjunct to other diagnostic evaluations to help differentiate essential tremor (an involuntary shaking of the hands, head, and face) from tremor due to PS. DaTscan cannot differentiate between the different types of PS.

Read full press release from GE Healthcare

GE Fact Sheet on DaTscan

Dr. Michael Okun, NPF’s National Medical Director, answers the question: “Should I get a DaTscan or PET scan to confirm my diagnosis of Parkinson’s?” in February’s blog.