33 Report on Survey of the Adverse Reaction to Radiopharmaceuticals (The 28th Survey in 2002) 6 * Subcommittee of Safety Issue for the Radiopharmaceuticals Medical and Pharmaceutical Committee Japan Radioisotope Association ( 41: 33 46, 2004) I. 28 in vivo RI (adverse reaction) (drug defect) 27 ( 13 ) 24 1) 14 4 1 15 3 31 1 15 * 2 28 45 (0 113 8941) 6 II. 28 ( 14 ) 14 4 27 in vivo 15 4 28 29 ( 15 ) 15 5 31 14 III. 1,211 1,033 85.3% (Table 1) 32 38
34 41 1 (2004) Table 1 28 24 25 26 27 28 1998 1999 2000 2001 2002 A 1,206 1,197 1,212 1,210 1,211 B 991 1,031 1,044 1,048 1,033 B/A 82.2% 86.1% 86.1% 86.6% 85.3% C 38 27 25 27 32 C/B 3.8% 2.6% 2.4% 2.6% 3.1% D 1,349,099 1,374,561 1,401,962 1,390,843 1,395,928 E 34 29 24 27 37 E/D 0.0025% 0.0021% 0.0017% 0.0019% 0.0027% F 7 1 3 5 1 F/D 0.0005% 0.0001% 0.0002% 0.0004% 0.0001% Table 2 1988 90 1991 93 1994 96 1997 99 2000 02 (% 72.3 77.6 78.4 82.8 86.0 56 44 79 93 88 38 31 27 9 9 (10 ) 2.1 1.4 2.2 2.3 2.1 (10 ) 1.4 1.0 0.7 0.2 0.2 Table 3 V F A O (%) I- 2,943 1 5 6 0.2039 Tc-PYP 3,280 2 2 0.0610 I- 1,980 1 1 0.0505 Tc-DTPA 14,812 2 1 3 0.0203 Tc-DMSA 7,860 1 1 0.0127 I- 8,536 1 1 0.0117 Tc-GSA 11,676 1 1 0.0086 Tc- 26,378 2* 2* 0.0076 Tc-MIBI 27,211 1 1 2 0.0073 67 Ga- 142,512 1 3 1 5 0.0035 Tc-HM-PAO 31,854 1 1 0.0031 Tc-MAA 44,527 1 1 0.0022 Tc-HMDP 360,132 4 2 1 7 0.0019 I-IMP 69,958 1 1 0.0014 201 Tl- 218,578 1* 2 3* 0.0014 Tc-MDP 136,262 1 1 0.0007 16 (17*) 0 12 9 37 (38*) V; F; A; O; * 2
25 35 Table 4 1988 90 1991 93 1994 96 1997 99 2000 02 (V) 25 18 31 32 46 (0.9) (0.6) (0.9) (0.8) (1.1) (F) 0 0 0 0 0 (A) 11 11 26 31 24 (0.4) (0.3) (0.7) (0.8) (0.6) (O) 20 15 22 30 18 (0.7) (0.5) (0.6) (0.8) (0.4) 56 44 79 93 88 (2.1) (1.4) (2.2) (2.3) (2.1) ( ) 10, Table 5 ( 14 ) Tc- 02-01 V 44 185 MBq 5 T3 10 166/90 mmhg T3 200 ml 5 25 (10 ) 02-02* V 62 185 MBq 5 147/94 mmhg 56/ 201 Tl- (30 ) Tc-PYP 02-03 V 51 1 vial (2 ) 02-04 V 71 1 vial CCU 15 2 1A 110/ mmhg 80/ (30 ) Tc-MAA 02-05 O 66 1vial 12 ()
36 41 1 (2004) Tc-HM-PAO 02-06 V 54 1 vial 20 ml (1 ) Tc-MDP 02-07 V 31 555 MBq 112/60 mmhg (5 ) Tc-HMDP 02-08 V 33 555 MBq 3 (2 ) 02-09 A 55 1 vial 24 -VG 6 -VG 3 24 (6 ) 02-10 O 51 1 vial 2 20 90 ml CT 30 CT CT (45 ) 02-11 A 52 1 vial 10 C C 3 CT 2 (7 )
25 37 02-12 V 14 1 vial 3.5 1 2 100/60 mmhg 12/ 80/ (1 ) 02-13 V 56 1 vial 2 3 2 8 5 50/ mmhg 73 115/56 mmhg ICU (70 ) 02-14 V 20 1 vial 1 118/72 mmhg 60/ (5 ) Tc-DMSA 02-15 V 17 185 MBq 5 (5 ) Tc-DTPA 02-16 V 71 1 vial 101/51 mmhg 18/ 72/7 135/60 mmhg 65/SpO 2 100% O 2 2 l/ O 2 1 l/ (15 ) 02-17 A 71 1 vial 24 2 (13 ) 02-18 V 41 1 vial 128/80 mmhg (5 ) Tc-GSA 02-19 A 55 185 MBq 25 130/78 mmhg 60/ (30 )
38 41 1 (2004) Tc-MIBI 02-20 A 66 1 vial 12 24 P C 3 (3 ) 02-21 O 50 1 vial 30 60 160/112 mmhg (1 ) 67 Ga- 02-22 O 79 74 MBq 1 30 C C CRP 132/72 mmhg 70/ (7 ) 02-23 V 21 111 MBq 105/85 mmhg (10 ) 02-24 A 83 111 MBq 10 2 3 (3 ) 02-25 A 53 111 MBq 8 3 (3 ) 02-26 A 36 111 MBq 6 (2 ) 201 Tl- 02-02* V 62 74 MBq 5 147/94 mmhg 56/ Tc- (30 )
25 39 02-27 A 53 111 MBq 1 (1 ) 02-28 A 71 74 MBq ( ) I- 02-29 A 21 7.4 MBq 15 24 C VG (12 ) I-IMP 02-30 V 66 111 MBq 10 (10 ) I- 02-31 V 44 1 MBq 2 3 9 1 50/ 88/64 mmhg 21 64/ 90/64 mmhg (18 ) I- 02-32 O 63 18.5 MBq 2 T3 30 60 T3 5 10 150/90 mmhg 72/ (10 ) 02-33 O 56 37 MBq (10 ) 02-34 O 33 37 MBq 1 ml 9 ml 7 ml 9 ml 163/95 mmhg 86/ (90 )
40 41 1 (2004) 02-35 O 56 37 MBq 1 5 30 138/60 mmhg (5 ) 02-36 O 77 37 MBq 10 ml 1 O 2 1 l/10 110/60 mmhg (10 ) 02-37 A 61 18.5 MBq 20 ml 2 3 10 120/ mmhg * 2 (3 ) 1,033 3.1% 37 1 10 4 1,395,928 0.0027% 100,000 2.7 0.0001% 100,000 0.1 1.4 0.2 5 1998 0.0017 0.0027% 0.0001 0.0005% 37 5 24 37 (Table 1) 1988 2002 3 1988 100,000 2.3 1.4 (Table 2) 10 0.4 0.1 (Table 1) ( Tc) Tc-HMDP 7 ( I) I-6 ( 67 Ga) 67 Ga- 5 ( Tc) Tc-DTPA ( 201 Tl) 201 Tl- 3 ( Tc) Tc- ( Tc) Tc-PYP (2- ) ( Tc) Tc-MIBI 2 ( Tc) Tc- MAA ( Tc) Tc-HM-PAO ( Tc) Tc-MDP ( Tc) Tc- DMSA ( Tc) Tc-GSA ( I) I- N-
25 41-4- ( I) I- IMP ( I) I- 1 38 2 1 37 (V) (F) (A) (O) (Table 3) 1,033 () I- 0.2039% ( 100,000 204 ) Tc- PYP 0.0610% ( 61 ) I- 0.0505% ( 51 ) Tc-DTPA 0.0203% ( 20 ) Tc-DMSA 0.0127% ( 13 ) I- 0.0117% ( 12 ) Tc-GSA 0.0086% ( 9 ) Tc- 0.0076% ( 8 ) Tc-MIBI 0.0073% ( 7 ) 67 Ga- 0.0035% ( 4 ) Tc-HM-PAO 0.0031% ( 3 ) Tc-MAA 0.0022% ( 2 ) Tc-HMDP 0.0019% ( 2 ) I-IMP 0.0014% ( 1 ) 201 Tl- 0.0014% ( 1 ) Tc-MDP 0.0007% ( 1 ) (Table 3) 2) I- 0.1% (Society of Nuclear Medicine) 3) 18 783,525 18 100,000 2.3 (European Association of Nuclear Medicine) 4) 100,000 11 Table 6 24 25 26 27 28 1998 1999 2000 2001 2002 6 5 4 3 7 (18%) (17%) (17%) (11%) (19%) 15 7 11 9 13 (44%) (24%) (46%) (33%) (35%) 9 14 8 13 11 (26%) (48%) (33%) (48%) (30%) 3 2 0 1 6 (9%) (7%) (4%) (16%) 1 1 1 1 0 (3%) (3%) (4%) (4%) 34 29 24 27 37 Table 7 24 25 26 27 28 1998 1999 2000 2001 2002 2 0 0 0 1 (6%) (3%) 11 10 7 5 7 (32%) (34%) (29%) (19%) (19%) 21 19 17 22 29 (62%) (66%) (71%) (81%) (78%) 34 29 24 27 37 (V) 16 (02-01 02-02 02-03 02-04 02-06 02-07 02-08 02-12 02-13 02-14 02-15 02-16 02-18 02-23 02-30 02-31) (A) 12 (02-09 02-11 02-17 02-19 02-20 02-24 02-25 02-26 02-27 02-28 02-29 02-37) (O) 9 (02-05 02-10 02-21 02-22 02-32 02-33 02-34 02-35 02-36) (Table 3 5) 1988 2002 15 (Table 4) 1997 (V) (A) (O) 10
42 41 1 (2004) Table 8 (1975 2002 ) 1 20 21 22 23 24 25 26 27 28 1975 1994 1995 1996 1997 1998 1999 2000 2001 2002 Tc-HMDP 3 4 ( 2) 2 ( 1) 4 ( 2) 2 ( 1) 6 ( 2) 1 ( 0) 6 ( 2) 7 ( 2) 35 I- 162 5 (168) 8 (275) 6 (202) 12 (391) 6 (197) 6 (203) 5 (170) 6 (204) 216 67 Ga- 19 1 ( 1) 2 ( 1) 4 ( 3) 2 ( 1) 5 ( 4) 33 Tc-DTPA 55 1 ( 5) 4 ( 19) 1 ( 5) 3 ( 15) 2 ( 11) 3 ( 20) 69 201 Tl- 6 2 ( 1) 3 ( 1) 3 ( 1) 4 ( 2) 2 ( 1) 1 ( 0) 2 ( 1) 3 ( 1) 26 Tc- 14 1 ( 4) 2 ( 8) 17 Tc-PYP 28 3 ( 29) 2 ( 35) 1 ( 20) 1 ( 16) 1 ( 18) 2 ( 47) 2 ( 61) 40 Tc-MIBI 3 1 ( 7) 2 ( 12) 2 ( 10) 1 ( 4) 2 ( 7) 11 Tc-MAA 8 1 ( 3) 1 ( 2) 1 ( 2) 1 ( 2) 12 Tc-HM-PAO 3 1 ( 3) 1 ( 3) 5 Tc-MDP 13 1 ( 1) 1 ( 1) 1 ( 1) 1 ( 1) 3 ( 2) 3 ( 2) 3 ( 2) 1 ( 1) 27 Tc-DMSA 5 3 ( 36) 1 ( 13) 9 Tc-GSA 1 1 ( 8) 1 ( 10) 1 ( 8) 1 ( 9) 5 I- 0 1 ( 7) 1 ( 8) 1 ( 12) 3 I-IMP 2 1 ( 2) 1 ( 2) 1 ( 2) 1 ( 2) 1 ( 1) 7 I- 234 3 ( 39) 1 ( 22) 1 ( 27) 3 (102) 1 ( 51) 243 Tc- 4 4 Tc- 6 6 Tc-ECD 0 2 ( 4) 1 ( 2) 3 ( 5) 1 ( 1) 1 ( 1) 8 Tc-HSA-DTPA 1 1 ( 5) 2 ( 13) 1 ( 7) 5 Tc-HSA 4 1 ( 9) 5 Tc-PMT 1 1 Tc- 0 1 ( 4) 1 ( 3) 2 Tc-MAG 3 2 3 ( 15) 4 ( 19) 1 ( 5) 1 ( 5) 2 ( 10) 13 I-MIBG 0 1 ( 6) 1 ( 5) 1 ( 5) 3 I-BMIPP 2 1 ( 3) 3 ( 7) 2 ( 4) 8 I-() 1 1 ( 13) 2 I-MIBG 0 1 ( 33) 2 ( 64) 3 I- 12 12 111 In- 1 1 111 In-DTPA 12 12 843 10
25 43 Table 9 Tc-HMDP 360,132 1 1 0.0003 1 1 Table 10 ( 14 ) Tc-HMDP 3 1 3 02-101 1 vial 1 3 0.8 1.1 0.6 0.8 0.4 0.8 54% 84% (Table 5 6) 3% 19% 78% (Table 5 7) 1 (02-13) Tc-HMDP 3 56 I- 1975 (Table 8) I- 6 1975 216 6 5 7 6 5,6) (Table 9, 10) 1 (02-101) 0.0001% 1988 2002 3 Table 11
44 41 1 (2004) Table 11 1988 90 1991 93 1994 96 1997 99 2000 02 10 13 8 0 7 (0.4) (0.4) (0.2) (0.2) 9 3 3 5 1 (0.3) (0.1) (0.1) (0.1) (0) 5 2 1 0 0 (0.2) (0.1) (0) 3 0 0 1 0 (0.1) (0) 3 4 2 1 0 (0.1) (0.1) (0.1) (0) 8 9 8 1 0 (0.3) (0.3) (0.2) (0) 1 0 5 1 1 (0) (0.1) (0) (0) 39 31 27 9 9 (1.4) (1) (0.7) (0.2) (0.2) ( ) 10 PET PET 29 ( 15 ) 15 O- 18 F- (FDG) 15 4 14 39 1) : 1979; 16: 511 516 2 1981; 18: 415 419 3 ( 55 6 ) 1982; 19: 1099 1105 4 ( 56 7 ) 1983; 20: 419 424 5 ( 57 8 ) 1984; 21: 283 287 6 ( 58 9 ) 1985; 22: 551 555 7 ( 59 10 ) 1986; 23: 455 460 8 ( 60 11 ) 1987; 24: 497 503 9 ( 61 12 ) 1988; 25: 367 373 10 ( 62 13 ) 1989; 26: 565 572 11 ( 63 14 ) 1991; 28: 323 328 12 ( 15 ) 1991; 28: 437 444 13 ( 2 16 ) 1992; 29: 399 405 14 ( 3 17 ) 1993; 30: 575 581 15 ( 4 18 ) 1994; 31: 289 296 16 (
25 45 5 19 ) 1995; 32: 605 614 17 ( 6 20 ) 1996; 33: 675 686 18 ( 7 21 ) 1997; 34: 267 279 19 ( 8 22 ) 1998; 35: 159 172 20 ( 9 23 ) 1999; 36: 249 260 21 ( 10 24 ) 2000; 37: 237 248 22 ( 11 25 ) 2001; 38: 139 150 23 ( 12 26 ) 2002; 39: 55 65. 24 ( 13 27 ) 2003; 40: 39 50 2) 607 ( 9 4 25 ): 3) Silberstein EB, Ryan J and the Pharmacopoeia Committee of the Society of Nuclear Medicine: Prevalence of Adverse Reactions in Nuclear Medicine. J Nucl Med 1996; 37: 185 192. 4) Hesslewood SR, Keeling DH and the Radiopharmacy Committee of the European Association of Nuclear Medicine: Frequency of adverse reactions to radiopharmaceuticals in Europe. Eur J Nucl Med 1997; 24: 1179 1182. 5) : (2003 ) 6) : (2003 )
46 41 1 (2004) ( 14 ) TcO 4 ( ) 80 18 () 16,361 822 () 6,885 512 () 1,786 549 () 1,266 182 TcO 4 26,378 907 Tc 1,936 190 4,570 191 MAA 44,527 976 PYP 3,280 264 PYP (RBC ) 6,327 223 HM-PAO 31,854 295 ECD 68,317 730 MDP 136,262 453 HMDP 360,132 863 DMSA 7,860 471 DTPA 14,812 397 HSA 4,334 206 HSA-DTPA 10,981 633 PMT 3,209 440 GSA 11,676 415 MIBI 27,211 616 72,760 477 MAG 3 18,693 678 1,094 50 Tc 856,213 1,024 67 Ga () 124,057 980 () 17,896 480 () 559 54 67 Ga 142,512 996 201 Tl () 191,977 864 () 20,741 760 ( ) 3,963 447 () 1,897 167 201 Tl 218,578 983 I NaI () 8,536 593 () 151 50 IMP 69,958 581 MIBG 18,426 732 BMIPP 45,210 693 I 142,281 961 I NaI () 6,555 64 () 886 93 () 2,734 116 () 1,262 60 1,980 9 2,943 521 MIBG 3,107 484 136 42 I 19,603 672 111 In 1,156 241 DTPA 1,992 333 () 296 20 () 60 10 111 In 3,504 458 51 Cr 247 43 59 Fe 13 5 133 Xe ( ) 4,277 17 ( ) 2,873 104 () 23 2 133 Xe 7,173 121 81m Kr 305 3 5,499 208 81m Kr 5,804 211 1,395,928 1,033 14 (1) A 45 B 39 B/A 86.7% (2) 15 O 1,485 23 18 F 34,226 39 35,711 39