Memorials/Survivors

The following is listed for clinical field trials for NADA 141-189:

"Adverse Reactions: The following potential adverse drug reactions (number of
cases) were observed in the moxidectin injectable treatment group: vomiting (3),
diarrhea (2), weight loss (2), listlessness (1), seizures (1), injection site pruritus (3),
elevated body temperature (1). Injection site evaluations of the ProHeart 6 treated
dogs revealed no abnormalities.
Two geriatric dogs with a history of weight loss after the initial ProHeart® 6 injection
died within a month of the second 6-month injection. A third dog who was
underweight for its age and breed and who had a history of congenital problems
experienced lethargy following the initial injection of ProHeart® 6. The dog never
recovered and died 3 months later. Treatment with ProHeart® 6 could not be ruled out
as contributing to these observations."

The following signs and figures are taken from FDA10/1/04 report

ADE Report Description
The primary purpose for maintaining the FDA/CVM ADE database is to provide an early warning or signaling system for adverse effects not detected during premarket testing of FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals. The FDA/CVM ADE reporting system depends upon the detection of an adverse clinical event by veterinarians and animal owners, the attribution of the clinical event to the use of a particular drug ("suspect" drug), and the reporting of the ADE to the manufacturer of the suspected drug or directly to FDA. Data from these ADE reports are coded and entered into the computerized FDA/CVM ADE database.

DEPRESSION/LETHARGY
URTICARIA
DIARRHEA
ANOREXIA
EDEMA, HEAD/FACE
SWELLING, HEAD/FACE
FEVER, BODY
PRURITIS
INEFFECT, HW LARVAE
CONVULSION(S)
EDEMA
PALLOR,MUCOUS MEMBRAN
COLLAPSE
INJ SITE SWELLING
SHOCK
ATAXIA
WBC HI, BLD
SGPT/ALT HI, BLD
DYSPNEA
WEIGHT LOSS
DIARRHEA, BLOODY
ALK PHOS HI, BLD
WEAKNESS
ANEMIA
CONGESTION, SKIN
POLYPNEA
RECUMBENCY
PLATELETS LO, BLD
BUN HI, BLD
TREMBLING
PAIN
HYPERSALIVATION
INJ SITE MASS
TACHYCARDIA
ANEMIA, AUTOIMMUNE HEM
CREATININE HI, BLD
INJ SITE PAIN
SEGS HI, BLD
BILIRUBIN(TOT) HI, BLD
RADIOGRAPH(S) ABN
BLD, URINE
ALBUMIN LO, BLD
DEHYDRATION
INJ SITE INFLAM
NERVOUSNESS
PR-LIVER, LESION(S)
COUGHING
VOMITING, BLOODY
INJ SITE ALOPECIA
SGOT/AST HI, BLD
LAMENESS
RELUCTANT TO MOVE
LIVER ENZYMES HI, BLD
SHAKING
PALLOR
POLYDIPSIA
ALOPECIA
AMYLASE HI, BLD
PAIN, ABDOMEN
PR-INJ SITE, LESION(S)
PROTEIN(TOT) LO, BLD
CONFUSION
PARESIS, HIND LIMB(S)
PR-SKIN, LESION(S)
BRADYCARDIA
INFLAM, SKIN
P HI, BLD
INJ SITE ABSCESS
US ABN
POLYCYTHEMIA
BLD(PETECHIAE)
DIARRHEA, MILD
DIFFICULTY RISING
HYPERPNEA
INJ SITE PRURITIS
PR-KIDNEY(S), LESION(S
SWELLING, EYE(S)/LID(S
VOCALIZATION
GLUCOSE HI, BLD
HYPERACTIVITY
WBC LO, BLD
HYPOTHERMIA, BODY
ICTERUS, BODY
LIPASE HI, BLD
MELENA
MONOS HI, BLD
PROTEIN, URINE

1097
764
554
548
408
401
392
386
370
360
326
275
226
217
196
183
181
180
176
175
169
156
152
151
140
137
133
110
95
74
69
68
66
65
64
62
60
60
59
59
57
55
55
55
55
54
53
52
51
50
48
45
44
42
40
40
39
39
39
39
37
36
36
36
35
35
35
33
33
32
31
31
31
31
31
31
31
31
30
29
29
28
27
27
27
27
27

21
14
10
10
8
8
7
7
7
7
6
5
4
4
4
3
3
3
3
3
3
3
3
3
3
3
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1