GE Healthcare (NYSE:GE) is pleased to announce that the US Drug Enforcement Administration (DEA) has removed the compound ioflupane I 123 from the schedules of the Controlled Substance Act, which has resulted in the descheduling of DaTscan™ (Ioflupane I 123 Injection). DaTscan is the FDA-approved imaging agent which provides an assessment of the integrity of the striatal dopaminergic system via the dopamine transporter to help physicians determine whether patients have essential tremor (ET) or a parkinsonian syndrome (PS) movement disorder such as Parkinson’s disease (PD). The action may help ensure that more healthcare providers and patients with a suspected PS or ET across the United States will have access to imaging with this agent.
DaTscan is a radioactive drug that is injected into the bloodstream to help image areas of the brain using an imaging technique called “SPECT” (single-photon emission computed tomography). For an adult with a suspected PS, a doctor may decide to conduct SPECT imaging with DaTscan, along with other medical tests, to help decide if movement difficulties are due to a PS or a similar condition known as ET. Types of PS include PD, multiple system atrophy, and progressive supranuclear palsy. DaTscan was not designed to differentiate among different forms of PS. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established. Movement disorders are primarily diagnosed through clinical examinations. However, clinical exams alone, particularly early in the disease, may be inconclusive and can result in misdiagnosis. The most common side effects of DaTscan are headache, upset stomach, a sensation of motion, dry mouth, and dizziness.
“We fully support the DEA’s decision to remove ioflupane I 123, the active ingredient in DaTscan, from the Schedules of the Controlled Substances Act,” said Etienne Montagut, global product leader of neurology and cardiology for GE Healthcare. “Because of the DEA’s decision, this important imaging tool will be more widely available to the medical community. Increasing the availability of DaTscan helps us fulfill our commitment to provide innovative, high-quality, and affordable healthcare solutions to patients who need them most.”
“The Parkinson’s Action Network (PAN) applauds the DEA for descheduling the active ingredient in DaTscan and allowing many more people to have access to this important diagnostic tool,” said Ted Thompson, JD, chief executive officer of PAN. “Having this tool available for people with suspected parkinsonian syndromes and essential tremor may help them to receive appropriate diagnosis and treatment sooner.”
Since the approval of DaTscan in 2011, it has been listed by the DEA as a Schedule II controlled substance. This has restricted its 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. Descheduling has removed these roadblocks, making it easier for imaging specialists to initiate and order DaTscan, as well as to compliantly administer it in their facilities.
GE Healthcare would like to thank the DEA, the US Food and Drug Administration, and the movement disorder community for their collaborative efforts to achieve this important milestone for Parkinson’s patients.
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Important Risk and Safety Information About DaTscan™ (Ioflupane I 123 Injection)
INDICATIONS AND USE: DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single-photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PSs). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy [PSP]). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established. CONTRAINDICATIONS: DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine. WARNINGS AND PRECAUTIONS — Hypersensitivity Reactions: Hypersensitivity reactions, generally consisting of skin erythema and pruritus, have been reported following DaTscan administration. Thyroid Accumulation: The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least one hour before administration of DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia. ADVERSE REACTIONS: In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported. DRUG INTERACTIONS: Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image. The impact of dopamine agonists and antagonists on DaTscan imaging results has not been established. SPECIFIC POPULATIONS — Pregnancy: It is unknown whether DaTscan can cause fetal harm or increase the risk of pregnancy loss in pregnant women. DaTscan should be given to pregnant women only if clearly needed. Like all radiopharmaceuticals, DaTscan may cause fetal harm, depending on the stage of fetal development and the magnitude of the radionuclide dose. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Nursing Mothers: It is not known whether DaTscan is excreted into human milk; however, I-123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan at all. Nursing women may consider interrupting nursing and pump and discard breast milk for six days after DaTscan administration to minimize risks to a nursing infant. Pediatric Use: The safety and efficacy of DaTscan have not been established in pediatric patients. Geriatric Use: There were no differences in responses between the elderly and younger patients that would require a dose adjustment. Renal and Hepatic Impairment: The effect of renal or hepatic impairment on DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images. OVERDOSAGE: It is unknown whether or not ioflupane is dialyzable. The major risks of overdose relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. PROCEDURE — Radiation Safety: DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.
Prior to DaTscan™ (Ioflupane I 123 Injection) administration, please read the Full Prescribing Information.