Parkinson's Imaging Agent Descheduled

September 15, 2015

The imaging agent, ioflupane I 123 (DaTscan; GE Healthcare), has been removed from the schedules of the US Controlled Substances Act, meaning that it will be more widely available for use in the diagnosis of Parkinson's disease and associated conditions.

Ioflupane I 123 is a US Food and Drug Administration–approved imaging agent that allows an assessment of the integrity of the striatal dopaminergic system via the dopamine transporter to help physicians determine whether patients have essential tremor or a parkinsonian syndrome movement disorder, such as Parkinson's disease.

Since approval in 2011, it has been listed by the Drug Enforcement Administration (DEA) as a Schedule II controlled substance, which has restricted the drug's use to only those healthcare professionals and imaging facilities registered with the DEA and able to comply with all of the requirements for the appropriate prescribing, storage, use, and disposal of Schedule II controlled substances.  

But the DEA has now descheduled ioflupane I 123, lifting these restrictions, making it easier for imaging specialists to order and administer it in their facilities.

DaTscan is a radioactive drug injected into the bloodstream to help image areas of the brain using single-photon emission computed tomography (SPECT). SPECT with DaTscan, along with other medical tests, aids in diagnosis of a Parkinsonian syndrome or essential tremor. Parkinsonian syndromes include Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy.

DaTscan was not designed to differentiate among these different forms of parkinsonian syndrome, the company release notes. Its effectiveness as a screening or confirmatory test and for monitoring disease progression or response to therapy has also not been established.

Quoted in a GE Healthcare press release, Ted Thompson, JD, chief executive officer of the Parkinson's Action Network, said, "The Parkinson's Action Network applauds the DEA for descheduling the active ingredient in DaTscan and allowing many more people to have access to this important diagnostic tool. Having this tool available for people with suspected Parkinsonian syndromes and essential tremor may help them to receive appropriate diagnosis and treatment sooner."


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.