Safety Analysis of 10 Clinical Trials and for 13 Years After First Approval of Ioflupane 123I Injection (DaTscan)

• DOI: 10.2967/jnumed.114.138032
• Publication Date: 2014-06-20T07:59:33Z
• Authors: Donald G. Grosset; Klaus Tatsch; Wolfgang H. Oertel; Eduardo Tolosa; Nin Bajaj; Andreas Kupsch; John T. O’Brien; John Seibyl; Zuzana Walker; Paul Sherwin; Chris Chen; Igor D. Grachev
• Keywords: Male; Clinical Trials as Topic; Nortropanes; Middle Aged; Injections; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Government Regulation; Humans; Female; Safety; Drug Approval; Aged

Ioflupane is an analog of cocaine that binds reversibly with high affinity to the dopamine transporter (DaT) protein, a marker for presynaptic terminals in dopaminergic nigrostriatal neurons. ¹²³I Injection also known as DaTscan or DaTSCAN (¹²³I-ioflupane called ¹²³I-2-β-carbomethoxy-3β-(4-iodophenyl)-<i>N</i>-(3-fluoropropyl)nortropane ¹²³I-FP-CIT). The diagnostic efficacy has been described elsewhere. Here, we present comprehensive analysis safety starting from initiation clinical development through 13 y after date first market approval. Safety data sponsor’s database 10 completed trials were pooled, and postapproval experience was summarized standardized aggregate reports submitted regulatory agencies. A total 1,180 trial subjects (92% 1,284 planned receive trials) received DaTscan. Percentages adverse events by category follows: all (22%), considered at least possibly related investigator (4%), any severe (3%), headache nausea (2%), dizziness nasopharyngitis (1%), injection site hematoma (1%). Four percent had 1 serious event; 5 (&lt;1%) led death. All events, including those death, deemed expert clinician be unrelated An estimated half million doses (for single use) administered July 2000 2013 reporting period. In assessment, death reported 20 d (and to) administration. Two spontaneously drug reactions (ADRs) 32 nonserious ADRs submitted, approximately which are identified labeling. Headache (in pain (postapproval) most commonly reactions. Although subjects, mild Severe uncommon, no event occurring more than subject experience, frequency less per 10,000 administered. Comprehensive show well tolerated.