2006 Drug ADE Comparison


FDA/CVM Cumulative Adverse Drug Experiences Summaries.

As you may know, the format of the Cumulative Report was recently changed. According to the FDA/CVM it was for "openness and transparency" (easier to read/understand) .

Veterinarians and caregivers are encouraged to make reports. There is also a Glossary of terminology.

The chart below is a summary by chemical (alphabetically) name of the drugs that appear to be the most commonly requested. The numbers are 'possible, probable or definitely related' for a category of drug, route of administration and species.

Some of the differences noticed are: 'Died' use to be a total of deaths possibly related, now it is broken down into 'death' and 'euthanize'. It use to be 'reacted' and apparently is now 'evaluated'.

There are interesting charts in the May/June 2001 FDA Veterinarian on page 11. FDA/CVM 1999 Adverse Drug Event Reports - A Descriptive Overview. i.e. 1992 - 1,011 reports were made yet in 1999 - 9,731 were .

 

NSAIDs
Heartworm Preventatives

 

NSAIDs
carprofen - oral (Rimadyl®)
NADA#141-053 Manf:Pfizer® Approved: 10/15/96
Nov '05 Report Treated: 14439 Reacted: 14032 Died: 3003
Mar '06 Report Evaluated: 14540 Death: 1625 Euthanize: 1202
Apr '06 Report Evaluated: 14580 Death: 1634 Euthanize: 1207
May '06 Report Evaluated: 14611
Death: 1643/ Euthanize: 1211= 2854
June '06 Report Evaluated: 14645
Death: 1652/ Euthanize: 1214 = 2866
July '06 Report Evaluated: 14707
Death: 1669/ Euthanize: 1225 = 2894
August '06 Report Evaluated: 14769
Death: 1681/ Euthanize: 1235 = 2916
Sept '06 Report Evaluated: 14804
Death: 1687/ Euthanize: 1242 = 2929
Oct '06 Report
No Change Total 2929
Nov '06 Report
No Change Total 2929
Dec '06 Report Evaluated: 14826
Death: 1692/ Euthanize: 1247 = 2939
Jan '07 Report Evaluated: 14826
Death: 1692/ Euthanize: 1249 = 2941
       
carprofen - inj (Rimadyl®)
NADA#141-199 Manf:Pfizer® Approved: 5/3/03
Nov '05 Report Treated: 517 Reacted: 350 Died: 85
Mar '06 Report Evaluated: 376 Death: 52 Euthanize: 34
Apr '06 Report Evaluated: 384 Death: 56 Euthanize: 35
May '06 Report Evaluated: 435
Death: 56 / Euthanize: 34 = 90
June '06 Report Evaluated: 466
Death: 64/ Euthanize: 34 = 98
July '06 Report Evaluated: 477
Death: 67/ Euthanize: 38 = 105
August '06 Report Evaluated: 486
Death: 69/ Euthanize: 39 = 108
Sept '06 Report Evaluated: 492
Death: 71/ Euthanize: 39 = 110
Oct '06 Report
No Change
Nov '06 Report Evaluated: 499
Death: 72/ Euthanize: 40 = 112
Dec '06 Report Evaluated: 505
Death: 72/ Euthanize: 40 = 112
Jan '07 Report Evaluated: 505
Death: 72/ Euthanize: 40 = 112
       
deracoxib - oral (Deramaxx®)
NADA#141-203 Manf:Novartis® Approved: 8/21/02
Nov '05 Report Treated: 3593 Reacted: 3513 Died: 839
Mar '06 Report Evaluated: 3632 Death: 345 Euthanize: 343
Apr '06 Report Evaluated: 3632 Death: 345 Euthanize: 343
May '06 Report Evaluated: 3632
No Change - Total 688
June '06 Report
No Change
July '06 Report
No Change
August '06 Report Evaluated: 3633
No Change
Sept '06 Report
No Change
Oct '06 Report
No Change
Nov '06 Report Evaluated: 3639
Death: 346/ Euthanize: 344 = 690
Dec '06 Report Evaluated: 3653
Death: 347/ Euthanize: 346 = 693
Jan '07 Report Evaluated: 3659
Death: 347/ Euthanize: 346 = 693
       
etodolac - oral (Etogesic®)
NADA#141-108 Manf:Wyeth® Approved: 7/22/98
Nov '05 Report Treated: 1950 Reacted: 1803 Died: 199
Mar '06 Report Evaluated: 1814 Death: 79 Euthanize: 70
Apr '06 Report Evaluated: 1814 Death: 79 Euthanize: 70
May '06 Report Evaluated: 1814
No Change - Total 149
June '06 Report Evaluated: 1815
No Change - Total 149
July '06 Report
No Change
August '06 Report Evaluated: 1816
No Change
Sept '06 Report
No Change Total 149
Oct '06 Report
No Change Total 149
Nov '06 Report
No Change Total 149
Dec '06 Report
No Change Total 149
Jan '07 Report Evaluated: 1816
Death: 79/ Euthanize: 70 = 149
       
firocoxib - oral (Previcox®)
NADA#141-230 Manf:Merial® Approved: 7/21/04
(not released till 2005
)
Nov '05 Report Treated: 144 Reacted: 142 Died :18
Mar '06 Report Evaluated: 321 Death: 16 Euthanize: 10
Apr '06 Report Evaluated: 360 Death: 20 Euthanize: 13
May '06 Report Evaluated: 387
Death: 21/ Euthanize: 15 = 36
June '06 Report Evaluated: 422
Death: 23/ Euthanize: 17 = 40
July '06 Report Evaluated: 486
Death: 30/ Euthanize: 25 = 55
August '06 Report Evaluated: 541
Death: 37/ Euthanize: 32 = 69
Sept '06 Report Evaluated: 604
Death:39/ Euthanize: 35 = 74
Oct '06 Report Evaluated: 639
Death: 41/ Euthanize: 36 = 77
Nov '06 Report Evaluated: 670
Death: 45/ Euthanize: 37 = 82
Dec '06 Report Evaluated: 794
Death: 57/ Euthanize: 43 = 100
Jan '07 Report Evaluated: 874
Death: 62/ Euthanize: 46 = 108
       
meloxicam - oral (Metacam®)
NADA#141-213 Manf:Boehringer Ingelheim Vetmedica® Approved: 4/15/03
Nov '05 Report Treated: 794 Reacted: 787 Died: 109
Mar '06 Report Evaluated: 816 Death: 72 Euthanize: 38
Apr '06 Report Evaluated: 821 Death: 73 Euthanize: 38
May '06 Report Evaluated: 831
Death: 75/ Euthanize: 38 = 113
June '06 Report Evaluated: 843
Death: 75/ Euthanize: 41 = 116
July '06 Report Evaluated: 848
Death: 75/ Euthanize: 42 = 117
August '06 Report Evaluated: 1005
Death: 76/ Euthanize: 45 = 121
Sept '06 Report Evaluated: 1042
Death: 80/ Euthanize: 47 = 127
Oct '06 Report Evaluated: 1070
Death: 83/ Euthanize: 49 = 132
Nov '06 Report Evaluated: 1076
Death: 85/ Euthanize: 50 = 135
Dec '06 Report Evaluated: 1090
Death: 87/ Euthanize: 53 = 140
Jan '07 Report Evaluated: 1112
Death: 89/ Euthanize: 57 = 146
       
meloxicam - inj (Metacam®)
NADA#141-219 Manf:Boehringer Ingelheim Vetmedica® Approved: 11/12/03
Nov '05 Report Treated: 55 Reacted: 55 Died: 18
Mar '06 Report Evaluated: 64 Death: 16 Euthanize: 2
Apr '06 Report Evaluated: 66 Death: 16 Euthanize: 2
May '06 Report Evaluated: 69
Death: 17/ Euthanize: 2 = 19
June '06 Report
No Change
July '06 Report Evaluated: 72
Death: 18/ Euthanize: 2 = 20
August '06 Report Evaluated: 75
Death: 19/ Euthanize: 2 = 21
Sept '06 Report Evaluated: 77
Death: 20/ Euthanize: 2 = 22
Oct '06 Report
No Change
Nov '06 Report Evaluated: 79
No Change Total 22
Dec '06 Report Evaluated: 89
Death: 21/ Euthanize: 3 = 24
Jan '07 Report Evaluated: 92
Death: 21/ Euthanize: 3 = 24
       
tepoxalin - oral (Zubrin®)
NADA#141-193 Manf:Schering-Plough® Approved: 3/31/03
Nov '05 Report Treated: 533 Reacted: 503 Died: 73
Mar '06 Report Evaluated: 508 Death: 27 Euthanize: 33
Apr '06 Report Evaluated: 508 Death: 27 Euthanize: 33
May '06 Report Evaluated: 509
Death: 27/ Euthanize: 33 = 60
June '06 Report Evaluated: 588
Death: 32/ Euthanize: 35 = 67
July '06 Report Evaluated: 590
No Change
August '06 Report Evaluated: 591
No Change
Sept '06 Report Evaluated: 593
Death: 32/ Euthanize: 36 = 68
Oct '06 Report Evaluated: 596
Death: 33/ Euthanize: 36 = 69
Nov '06 Report Evaluated: 598
Death:33/ Euthanize: 37 = 70
Dec '06 Report Evaluated: 608
Death: 34/ Euthanize: 37 = 71
Jan '07 Report Evaluated: 615
Death: 35/ Euthanize: 37 = 72
       
Heartworm Preventatives

ivermectin - oral
(Heartgard®)
(IverHart®)
(Valuheart®)

NADA#138-412/140-886
NADA#200-270
NADA#oustide USA
Manf: Merck®
Manf: Blue Ridge®
Manf:
Approved: 7/89 10/96
Approved: 11/01
Approved: n/a
Nov '05 Report Treated:  1095 Reacted:  992 Died:  149
Mar '06 Report Evaluated: 992 Death: 102 Euthanize: 6
Apr '06 Report Evaluated: 1004 Death: 103 Euthanize: 6
May '06 Report Evaluated: 1004
No Change - Total 109
June '06 Report Evaluated: 1021
No Change - Total 109
July '06 Report Evaluated: 1023
No Change
August '06 Report Evaluated: 1024
No Change
Sept '06 Report Evaluated: 1037
No Change
Oct '06 Report Evaluated: 1041
No Change - Total 109
Nov '06 Report Evaluated: 1046
No Change - Total 109
Dec '06 Report
No Change
Jan '07 Report Evaluated: 1060
Death: 103/ Euthanize: 6 = 109
       

ivermectin plus - oral
(Heartgard+®)
(IverHart+®)
(Triheart+®)

NADA#140-971
NADA#200-302
NADA#200-338
Manf: Merek®
Manf: BlueRidge®
Manf: Heske®
Approved: 1/15/93
Approved: 5/30/01
Approved: 8/03
Nov '05 Report Treated:  5066 Reacted:  4771 Died:  83
Mar '06 Report Evaluated: 6074 Death: 59 Euthanize: 14
Apr '06 Report Evaluated: 6654 Death: 59 Euthanize: 15
May '06 Report Evaluated: 6808
Death: 59/ Euthanize: 15 = 74
June '06 Report Evaluated: 6837
Death: 60/ Euthanize: 15 = 75
July '06 Report Evaluated: 6848
No Change
August '06 Report Evaluated: 6929
No Change
Sept '06 Report Evaluated: 7434
Death:62/ Euthanize: 17 = 79
Oct '06 Report Evaluated: 7605
Death: 63/ Euthanize: 17 = 80
Nov '06 Report Evaluated: 7805
Death: 63/ Euthanize: 18 = 81
Dec '06 Report Evaluated: 7969
Death: 65/ Euthanize: 18 = 83
Jan '07 Report Evaluated: 9142
Death: 66/ Euthanize: 18 = 84
       
milbemycin - oral (Interceptor®)
NADA#140-915 Manf: Novartis® Approved: 12/29/92
Nov '05 Report Treated:  2386 Reacted:  2301 Died:  128
Mar '06 Report Evaluated: 3103 Death: 90 Euthanize: 21
Apr '06 Report Evaluated: 3265 Death: 92 Euthanize: 21
May '06 Report Evaluated: 3417
Death: 95/ Euthanize: 24= 119
June '06 Report Evaluated: 3512
Death: 96/ Euthanize: 24 = 120
July '06 Report Evaluated: 3518
Death: 97/ Euthanize: 24 = 121
August '06 Report
No Change
Sept '06 Report Evaluated: 3621
Death: 99/ Euthanize: 25 = 124
Oct '06 Report Evaluated: 3830
Death: 104/ Euthanize: 26 = 130
Nov '06 Report Evaluated: 3996
Death: 107/ Euthanize: 27 = 134
Dec '06 Report Evaluated: 4233
Death: 111/ Euthanize: 29 = 140
Jan '07 Report Evaluated: 4393
Death: 118/ Euthanize: 32 = 150
       
milbemycin/luf - oral (Sentinel®)
NADA#141-084 Manf: Novartis® Approved: 3/18/98
Nov '05 Report Treated:  1039 Reacted:  971 Died:  40
Mar '06 Report Evaluated: 991 Death: 20 Euthanize: 8
Apr '06 Report Evaluated: 991 Death: 20 Euthanize: 8
May '06 Report Evaluated: 1095
Death: 20/ Euthanize: 8= 28
June '06 Report Evaluated: 1177
No Change - Total 28
July '06 Report Evaluated: 1244
Death: 22/ Euthanize: 9 = 31
August '06 Report Evaluated: 1245
No Change
Sept '06 Report Evaluated: 1429
Death: 25/ Euthanize: 10 = 35
Oct '06 Report Evaluated: 1436
No Change - Total 35
Nov '06 Report Evaluated: 1469
Death: 26/ Euthanize: 10 = 36
Dec '06 Report Evaluated: 1515
No Change - Total 36
Jan '07 Report Evaluated: 1532
Death: 26/ Euthanize: 11 = 37
       
moxidectin - oral (Proheart® tablets)
NADA#141-051 Manf: Fort Dodge® Approved: 5/17/97
Nov '05 Report Treated:  394 Reacted:  356 Died:  62
Mar '06 Report Evaluated: 357 Death: 57 Euthanize: 5
Apr '06 Report Evaluated: 357 Death: 57 Euthanize: 5
May '06 Report Evaluated: 357
No Change - Total 62
June '06 Report
No Change
July '06 Report Evaluated: 360
Death: 58/ Euthanize: 5 = 63
August '06 Report Evaluated: 364
No Change
Sept '06 Report
No Change Total 63
Oct '06 Report
No Change Total 63
Nov '06 Report
No Change Total 63
Dec '06 Report
No Change Total 63
Jan '07 Report Evaluated: 365
Death: 58/ Euthanize: 5 = 63
       
moxidectin - inj (Proheart® 6)
NADA#141-189 Manf: Fort Dodge® Approved: 6/21/01
Nov '05 Report Treated:  6042 Reacted:  5473 Died:  599
Mar '06 Report Evaluated: 5473 Death: 344 Euthanize: 137
Apr '06 Report Evaluated: 5473 Death: 344 Euthanize: 137
May '06 Report Evaluated: 5473
No Change - Total 481
June '06 Report
No Change - Total 481
July '06 Report
No Change - Total 481
August '06 Report
No Change - Total 481
Sept '06 Report
No Change - Total 481
Oct '06 Report
No Change - Total 481
Nov '06 Report
No Change - Total 481
Dec '06 Report
No Change - Total 481
Jan '07 Report Evaluated: 5473
Death: 344/ Euthanize: 137 = 481
       
selamectin - topical (Revolution®)
NADA#141-152 Manf: Pfizer® Approved: 5/26/99
Nov '05 Report Treated:  9744 Reacted:  9552 Died:  224
Mar '06 Report Evaluated: 9697 Death: 128 Euthanize: 42
Apr '06 Report Evaluated: 9836 Death: 128 Euthanize: 42
May '06 Report Evaluated: 9895
Death: 128/ Euthanize: 42 = 170
June '06 Report Evaluated: 9924
No Change - Total 170
July '06 Report Evaluated: 10,215
Death: 130/ Euthanize: 43 = 173
August '06 Report Evaluated: 10,369
Death: 140/ Euthanize: 48 = 187
Sept '06 Report Evaluated: 10,452
Death: 142/ Euthanize: 48 = 190
Oct '06 Report Evaluated: 10,459
No Change - Total 190
Nov '06 Report Evaluated: 10,465
No Change - Total 190
Dec '06 Report Evaluated: 10510
No Change - Total 190
Jan '07 Report Evaluated: 10519
Death: 142/ Euthanize: 48 = 190