FDA-CVM FOIA Response 2017-963 February 8,...
Transcript of FDA-CVM FOIA Response 2017-963 February 8,...
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FDA-CVM FOIA Response 2017-963 February 8, 2017
This serves as the response to your Freedom of Information Act (FOIA) request for records regarding
adverse event reports received for afoxolaner, fluralaner, and sarolaner.
A search of CVM’s Adverse Drug Event (ADE) database was performed on 2/8/2017. The search
parameters were:
Active ingredient(s): afoxolaner, fluralaner and sarolaner
Reports received: From 10/16/2016 through 1/26/2017
Case type: Spontaneous ADE report
Species: All
Route of administration: All
For each drug (active ingredient), we have provided the ‘CVM ADE Comprehensive Clinical Detail Report
Listing’, which is a cumulative listing of adverse experiences in reports submitted to CVM.
General Information about CVM’s ADE Database
The primary purpose for maintaining the CVM ADE database is to provide an early warning or signaling system
to CVM for adverse effects not detected during pre-market testing of FDA-approved animal drugs and for
monitoring the performance of drugs not approved for use in animals. Information from these ADE reports is
received and coded in an electronic FDA/CVM ADE database. CVM scientists use the ADE database to make
decisions about product safety which may include changes to the label or other regulatory action. CVM’s ADE
reporting system depends on detection and voluntary reporting of adverse clinical events by veterinarians and
animal owners.
The Center's ADE review process is complex, and for each report takes into consideration
confounding factors such as:
Dosage
Concomitant drug use
The medical and physical condition of animals at the time of treatment
Environmental and management information
Product defects
Extra-label (off label) uses
The specifics of these complex factors cannot be addressed in the CVM ADE Comprehensive Clinical Detail
Report Listing.
How to Use the CVM ADE Comprehensive Clinical Detail Report Listing
Clinical signs reported for an active ingredient are listed in order from most frequently reported to least
frequently reported, grouped by species and route of administration.
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FDA-CVM FOIA Response 2017-963 February 8, 2017
More than one clinical sign may have been reported per ADE case report, so the ‘Number of times
reported’ column is not additive and does not necessarily represent the total number of reports
received. Also, if a manufacturer reports multiple products in a single ADE case report, clinical signs are
associated with each of the manufacturer’s products.
Afoxolaner, fluralaner and sarolaner are approved for oral use in dogs only. For the time period of the ADE
database search (10/16/2016 - 01/26/2017), there were a total of 697 ADE reports received for afoxolaner for
dogs, a total of 1131 ADE reports received for fluralaner for dogs, and a total of 36 ADE reports received for
sarolaner for dogs.
The following table shows the number of reports broken down by all species for which reports have been
received during this time period:
Species # Afoxolaner
reports
# Fluralaner
reports
# Sarolaner
reports
Dog 697 1131 36
Cat 4 94 0
Human (accidental exposures) 2 10 1
Total # ADE reports, all
species
703 1235 37
When reviewing the CVM ADE Comprehensive Clinical Detail Report Listing, the reader should be aware
that:
For any given ADE report, there is no certainty that the reported drug caused the adverse event. The
adverse event may have been related to an underlying disease, using other drugs at the same time, or
other non-drug related causes. The clinical detail listing does not include information about underlying
diseases, other drugs used at the same time, other non-drug related causes, or the final outcome of the
reaction.
The accuracy of information regarding the ADE is dependent on the quality of information received
from the reporting veterinarian or animal owner.
Accumulated ADE reports should not be used to calculate incidence rates or estimates of drug risk,
because there is no accurate way to determine how many animals were actually given the drug, which
is needed as the denominator in calculations of incidence and relative risk.
It is inappropriate to make use of adverse event data to compare the safety of different products.
For example, if a drug is widely used to treat certain conditions, there may be more ADEs for that
drug than another product that is not used as often. This would not mean that the first drug was
more unsafe than the second. The number of reports simply represents the number of ADEs
received for a particular drug and should not be used for any type of comparison purposes.
Underreporting occurs with most adverse event reporting systems. The frequency of reporting for a
given drug product varies over time, and may be greater when the drug is newly marketed, or when
media publicity occurs.
Information on how the drugs were used (for indications on the product label or in an extra label manner)
is not provided in the clinical detail listing.
More information about CVM’s ADE Reporting System can be found on our web site at:
http://www.fda.gov/AnimalVeterinary/SafetyHealth/default.htm.
CVM ADE Comprehensive Clinical Detail Report Listing
Cumulative Date Range : 16-Oct-2016 -thru- 26-Jan-2017
Included 1932a cases = : True
Included Medicated Feed cases = : False
DRUG: FLURALANER
Route of Administration: Species:
ORAL
Cat
Sign : Number of Times Reported :
GAGGING 1
HYPERSALIVATION 1
INEFFECTIVE, DEMODEX MITES 1
MEDICATION ERROR 1
Route of Administration: Species:
TOPICAL
Cat
Sign : Number of Times Reported :
LETHARGY 12
EMESIS (MULTIPLE) 8
ANOREXIA 7
APPLICATION SITE GREASY FUR 7
DIARRHOEA 6
APPLICATION SITE HAIR CHANGE 5
APPLICATION SITE HAIR LOSS 5
BEHAVIOURAL DISORDER NOS 5
VOMITING 5
ATAXIA 4
DECREASED APPETITE 4
HYPERSALIVATION 4
PANTING 4
FOAMING AT THE MOUTH 3
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DRUG: FLURALANER
Route of Administration: Species:
TOPICAL
Cat
Sign : Number of Times Reported :
HYPERACTIVITY 3
INEFFECTIVE, FLEAS 3
PRURITUS 3
AGITATION 2
ALOPECIA 2
APPLICATION SITE IRRITATION 2
COUGH 2
DEATH BY EUTHANASIA 2
DEHYDRATION 2
FALLING 2
HIDING 2
MALODOUR 2
TACHYCARDIA 2
TACHYPNOEA 2
TWITCHING 2
VOCALISATION 2
ABNORMAL BREATHING 1
ABNORMAL PUPIL LIGHT REFLEX 1
ABNORMAL TEST RESULT 1
AGGRESSION 1
ANAEMIA NOS 1
ANISOCORIA 1
ANTERIOR UVEITIS 1
APPLICATION SITE ALOPECIA 1
APPLICATION SITE ITCHING 1
APPLICATION SITE PARAESTHESIA 1
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DRUG: FLURALANER
Route of Administration: Species:
TOPICAL
Cat
Sign : Number of Times Reported :
APPLICATION SITE RASH 1
APPLICATION SITE RESIDUE 1
APPLICATION SITE SCAB 1
APPLICATION SITE SKIN DISCOLOURATION 1
APPLICATION SITE THICKENING 1
BLOOD IN VOMIT 1
BUMPING INTO WALLS 1
DECREASED DRINKING 1
DEPRESSION 1
DROOLING 1
ELECTROLYTE DISORDER 1
ELEVATED LIVER ENZYMES 1
ELEVATED SAP 1
EMESIS 1
EXCORIATION 1
EYE DISORDER NOS 1
FACIAL SWELLING 1
FEVER 1
GRANULOMA 1
GREASY SKIN 1
HAEMOLYTIC ANAEMIA 1
HAIR LOSS NOS 1
HEAD BOBBING 1
HEAD SHAKE - BEHAVIOURAL DISORDER 1
HYPERAESTHESIA 1
HYPERPHOSPHATAEMIA 1
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DRUG: FLURALANER
Route of Administration: Species:
TOPICAL
Cat
Sign : Number of Times Reported :
HYPERTHERMIA 1
HYPOGLYCAEMIA 1
IMMUNE MEDIATED HAEMOLYTIC ANAEMIA 1
IMPAIRED VISION 1
INAPPETENCE 1
INAPPROPRIATE DEFECATION 1
INAPPROPRIATE URINATION 1
INEFFECTIVE, DEMODEX MITES 1
IRIS DISORDER 1
ITCHING 1
KERATITIS 1
LABOURED BREATHING 1
LICKING 1
LIMB WEAKNESS 1
LUMP 1
MILIARY DERMATITIS 1
MIOSIS 1
MUSCULOSKELETAL DISORDER NOS 1
MYDRIASIS 1
OPEN MOUTH BREATHING 1
POLYDIPSIA 1
POLYPHAGIA 1
PR-SKIN, LESION(S) 1
RED EYE 1
REDDENING OF THE SKIN 1
SCRATCHING 1
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DRUG: FLURALANER
Route of Administration: Species:
TOPICAL
Cat
Sign : Number of Times Reported :
SEIZURE NOS 1
SKIN SWELLING 1
SQUINTING 1
STRAINING TO DEFECATE 1
ULCERATION NOS 1
UNRESPONSIVE TO STIMULI 1
WALKING DIFFICULTY 1
WEIGHT LOSS 1
Route of Administration: Species:
UNKNOWN
Cat
Sign : Number of Times Reported :
SEIZURE NOS 1
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
VOMITING 469
EMESIS (MULTIPLE) 131
LETHARGY 129
LACK OF EFFICACY (ECTOPARASITES) 114
DIARRHOEA 107
SEIZURE NOS 43
ANOREXIA 42
PRURITUS 30
WEIGHT LOSS 28
DECREASED APPETITE 27
BLOODY DIARRHOEA 26
DEATH BY EUTHANASIA 23
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
ABNORMAL TEST RESULT 22
BEHAVIOURAL DISORDER NOS 22
DEATH 21
POLYDIPSIA 21
ABNORMAL RADIOGRAPH FINDING 18
ELEVATED SAP 18
LOOSE STOOL 18
FEVER 16
HIVES 16
NOT EATING 16
ELEVATED ALT 15
INAPPETENCE 15
POLYURIA 15
SCRATCHING 14
DEHYDRATION 12
ABNORMAL ULTRASOUND FINDING 11
LEUCOCYTOSIS 11
SHAKING 11
DROOLING 10
PANTING 10
ELEVATED CREATININE 9
HYPERPHOSPHATAEMIA 9
ITCHING 9
DECREASED DRINKING 8
ELEVATED BUN 8
ELEVATED TOTAL BILIRUBIN 8
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
EMESIS 8
GENERAL HAIR LOSS 8
INAPPROPRIATE URINATION 8
VOCALISATION 8
ANAEMIA NOS 7
ERYTHEMA 7
FACIAL SWELLING 7
FLATULENCE 7
HYPOALBUMINAEMIA 7
LAMENESS 7
LICKING 7
PANCREATITIS 7
TREMOR 7
AGGRESSION 6
BLOOD IN FAECES 6
ELEVATED AMYLASE 6
ELEVATED GAMMA-GLUTAMYL TRANSFERASE (GGT) 6
NEUTROPHILIA 6
RENAL FAILURE 6
RESTLESSNESS 6
RETCHING 6
WALKING DIFFICULTY 6
ALOPECIA 5
ANXIETY 5
ATAXIA 5
CRUST 5
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
DECREASED PACKED CELL VOLUME (PCV) 5
DEPRESSION 5
DERMATITIS 5
ELEVATED LIPASE 5
ERYTHEMATOUS RASH 5
FREQUENT URINATION 5
GENERALISED ITCHING 5
HYPERACTIVITY 5
HYPERGLYCAEMIA 5
HYPERSALIVATION 5
INTESTINAL DISORDER NOS 5
MALAISE 5
MEDICATION ERROR 5
PYODERMA 5
SKIN SCAB 5
THROMBOCYTOPENIA 5
TREMBLING 5
TWITCHING 5
ABDOMINAL PAIN 4
ABNORMAL BREATHING 4
ADIPSIA 4
BLINDNESS 4
COUGH 4
DECREASED ACTIVITY 4
DISORIENTATION 4
DISTENSION OF ABDOMEN 4
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
DRY MUCOUS MEMBRANE 4
EXCORIATION 4
GLAZED EYE 4
HAEMATURIA 4
HOT SPOT (PYOTRAUMATIC DERMATITIS) 4
HYPERKALEMIC CONDITION 4
HYPONATREMIA 4
LACK OF EFFICACY 4
LATERAL RECUMBENCY 4
LOW PLATELET COUNT 4
MUSCULOSKELETAL DISORDER NOS 4
NAUSEA 4
OCULAR DISCHARGE 4
PALE MUCOUS MEMBRANE 4
PRODUCT PROBLEM 4
REDDENING OF THE SKIN 4
RELUCTANT TO MOVE 4
SKIN IRRITATION 4
THROMBOCYTOSIS 4
URINARY TRACT INFECTION 4
ABDOMINAL MASS 3
ARTHRITIS 3
ASCITES 3
BLOOD IN VOMIT 3
CONJUNCTIVITIS 3
DECREASED NUMBER OF SPERMATOZOA 3
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
DISCOMFORT NOS 3
DRY SKIN 3
ELEVATED LIVER ENZYMES 3
EOSINOPHILIA 3
FACIAL OEDEMA 3
GAGGING 3
HEAD TREMOR 3
HYPOKALEAEMIA 3
HYPOPROTEINAEMIA 3
ICTERUS 3
INAPPROPRIATE DEFECATION 3
ITCHY SKIN 3
LIMB WEAKNESS 3
LIMPING 3
LOCALISED RASH 3
MENTAL IMPAIRMENT NOS 3
MONOCYTOSIS 3
NASAL DISCHARGE 3
NYSTAGMUS 3
OTITIS EXTERNA 3
PAIN NOS 3
PAPULE 3
PLEURAL EFFUSION 3
PROTEINURIA 3
PUSTULES 3
RASH 3
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
RUBBING 3
SMELLY BREATH 3
STAR-GAZING 3
TOOTH DISORDER 3
UNCLASSIFIABLE ADVERSE EVENT 3
WEAKNESS 3
ABDOMINAL CAVITY DISORDER NOS 2
ABNORMAL NECROPSY FINDING 2
ABNORMAL PUPIL LIGHT REFLEX 2
ABNORMAL STOOL COLOURATION 2
ADDISON'S DISEASE 2
ADRENAL GLAND DISORDER NOS 2
AGITATION 2
APPETITE LOSS 2
BILIRUBINURIA 2
BLISTERING 2
BLOTCHY RASH 2
BREATHING DIFFICULTY 2
COLLAPSE 2
CRYING 2
DECREASED BOWEL MOVEMENTS 2
DECREASED CHOLESTEROL (TOTAL) 2
DECREASED URINE CONCENTRATION 2
DIABETES MELLITUS 2
DILATED PUPILS 2
ELEVATED BILE ACIDS 2
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
ELEVATED CREATININE-KINASE (CK) 2
ENLARGED LYMPH NODE 2
EPIPHORA 2
EXCESSIVE THIRST 2
EYE DISORDER NOS 2
FLAKING SKIN 2
GAIT ABNORMALITY 2
GASTROENTERITIS 2
GENERAL ILLNESS 2
GLUCOSURIA 2
HAEMATOCHEZIA 2
HEAD TILT 2
HEART MURMUR 2
HIDING 2
HYPERCALCAEMIA 2
HYPOGLYCAEMIA 2
HYPOSTHENURIA 2
IMMUNE MEDIATED HAEMOLYTIC ANAEMIA 2
INCOORDINATION 2
INCREASED HEART RATE 2
INEFFECTIVE, TICKS 2
INJECTION SITE PAIN 2
LABOURED BREATHING 2
LIP LICKING 2
LIVER DISORDER NOS 2
LIVER FAILURE 2
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
LOCALISED ITCHING 2
LOCALISED PAIN NOS 2
MUCOUS STOOL 2
ORAL CAVITY DISORDER NOS 2
PARALYSIS NOS 2
PICA NOS 2
PYURIA 2
RESPIRATORY DISTRESS 2
SHIVERING 2
SKIN ABSCESS 2
SKIN DISORDERS NOS 2
SKIN SORE 2
SKIN ULCER 2
SKIN WARMTH 2
SMALL LIVER 2
STIFFNESS NOS 2
STRAINING TO DEFECATE 2
SUDDEN DEATH 2
SWELLING AROUND EYE 2
SWELLING NOS 2
UNABLE TO STAND 2
UNCOMFORTABLE 2
URINE ABNORMALITIES NOS 2
URINE LEAKAGE 2
WEAKNESS OF LIMB 2
WEIGHT GAIN 2
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
WELT 2
ABDOMINAL CAVITY HAEMORRHAGE 1
ABDOMINAL DISCOMFORT 1
ABNORMAL POSTURE NOS 1
ABNORMAL SPERMATOZOA 1
ABNORMAL VISION 1
ALLERGIC PRURITUS 1
ALLERGY NOS 1
ALOPECIA GENERAL 1
ALOPECIA NOS 1
ANAL SAC DISORDER 1
ANGIOEDEMA 1
ANISOCORIA 1
APPETITE DISORDER NOS 1
ARCHED BACK 1
AURAL HAEMATOMA 1
AUTOIMMUNE DISORDER NOS 1
AZOTAEMIA 1
BACTERIAL SKIN INFECTION NOS 1
BALANCE PROBLEM 1
BIRTH DEFECT 1
BITING 1
BLADDER INCONTINENCE 1
BLOATED 1
BLOOD IN URINE 1
BOIL 1
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
BONE AND JOINT DISORDER NOS 1
BUMPING INTO WALLS 1
BUN LOW, BLD 1
CARDIAC ENLARGEMENT 1
CATARACT 1
CERVICAL SPONDYLOPATHY 1
CHLORIDE LOW, BLOOD 1
CIRCLING 1
COLITIS 1
CONFUSED 1
CONFUSION 1
CONSTIPATION 1
CONVULSION 1
COOMBS TEST POSITIVE 1
CORNEAL ULCER 1
CRANIAL NERVE DISORDER 1
CRYSTALLURIA 1
CUTANEOUS CALCINOSIS 1
CYANOSIS 1
DEAFNESS 1
DECREASED RED BLOOD CELL COUNT 1
DECREASED RESPIRATORY RATE 1
DEPRESSED REFLEXES 1
DERMAL CYST(S) 1
DERMAL MASS 1
DIABETES 1
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
DIABETIC KETONURIA 1
DIGESTIVE TRACT DISORDER NOS 1
DIGESTIVE TRACT HYPERMOTILITY 1
DISCOLOURED URINE 1
DISORIENTED STATE 1
DRINKING A LOT 1
DRY NOSE 1
DULL 1
DYSPNOEA 1
DYSTOCIA 1
EAR FLAP OEDEMA 1
EAR INFECTION NOS 1
EAR PAIN 1
ELECTROLYTE DISORDER 1
ELEVATED AST 1
ELEVATED CHOLESTEROL (TOTAL) 1
ELEVATED FIBRINOGEN LEVEL 1
ELEVATED GLOBULINS 1
ELEVATED TEMPERATURE 1
ENLARGED KIDNEY(S) 1
ENLARGED LIVER 1
ENTERITIS 1
EPILEPTIC SEIZURE 1
EPISTAXIS 1
EROSION 1
ERYTHEMA MULTIFORME 1
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
EXCESSIVE LICKING AND/OR GROOMING 1
EXTERNAL EAR DISORDER NOS 1
EYE ITCHING 1
FALLING 1
FLACCID MUSCLES 1
GALL BLADDER & BILE DUCT DISORDER NOS 1
GASTRIC IRRITATION 1
GENERAL PAIN 1
GENERALISED SKIN REACTION 1
HAEMOTHORAX 1
HAIR LOSS NOS 1
HAIR SHEDDING 1
HALITOSIS 1
HEAD BOBBING 1
HEAD SHAKE - BEHAVIOURAL DISORDER 1
HEAD SHAKE - EAR DISORDER 1
HEAD TILT - EAR DISORDER 1
HEPATIC DISORDER NOS 1
HIND LIMB ATAXIA 1
HIND LIMB PARESIS 1
HYPERAEMIC MUCOUS MEMBRANE 1
HYPERAESTHESIA 1
HYPERALBUMINAEMIA 1
HYPERCHLORAEMIA 1
HYPERMETRIA 1
HYPERNATREMIA 1
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
HYPERPIGMENTATION 1
HYPERSTHENURIA 1
HYPERTENSION 1
HYPOCALCAEMIC CONDITION 1
HYPOKALEMIC CONDITION 1
HYPOPHOSPHATAEMIA 1
HYPOTENSION 1
HYPOTHYROIDISM 1
IDIOPATHIC VESTIBULAR DISEASE 1
IMMUNE MEDIATED THROMBOCYTOPENIA 1
IMPAIRED VISION 1
INCREASED APPETITE 1
INCREASED BORBORYGMUS 1
INCREASED BOWEL MOVEMENTS (FREQUENCY) 1
INCREASED PACKED CELL VOLUME (PCV) 1
INCREASED RESPIRATORY RATE 1
INCREASED SEIZURE FREQUENCY 1
INCREASED SKIN SENSITIVITY 1
INJECTION SITE LUMP 1
INTESTINAL PERFORATION 1
INTRAUTERINE DEATH 1
INVOLUNTARY MOVEMENT 1
JAUNDICE 1
JOINT LIGAMENT DISORDER NOS 1
JOINT PAIN 1
LACK OF RESPONSE TO OWNER 1
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
LENS DISORDER NOS 1
LEUCOPENIA 1
LEUKAEMIA 1
LIP SMACKING 1
LIPAEMIA 1
LOCAL SWELLING (NOT APPLICATION SITE) 1
LOCALISED HAIR LOSS 1
LOOSE BOWEL 1
LOW VISION 1
LUMBAR PAIN 1
LUMP 1
LUNG TUMOUR 1
LYMPHOCYTOSIS 1
LYMPHOMA 1
MALODOUR 1
METABOLIC BONE DISORDER NOS 1
MISCARRIAGE 1
MOUTH PAIN 1
MOUTH ULCER 1
MUCOSA PETECHIAE 1
MULTI-ORGAN FAILURE NOS 1
MUSCLE TREMOR 1
MUSCULOSKELETAL PAIN 1
MYOCLONIC JERK 1
NASAL CONGESTION 1
NEPHROPATHY 1
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
NEUROLOGICAL SIGNS NOS 1
NEUROLOGICAL SYMPTOMS NOS 1
NOT DRINKING 1
NT - PROLIFERATIVE GLOMERULONEPHRITIS 1
OEDEMA OF THE EXTREMITIES 1
ORAL BLEEDING 1
ORAL MASS 1
OTHER EAR DISORDER NOS 1
OTITIS NOS 1
PACING 1
PADDLING 1
PAPULAR RASH 1
PEMPHIGUS FOLIACEUS 1
PERINATAL MORTALITY 1
PERITONITIS 1
PILOERECTION 1
POLLAKIURIA 1
POLYCYTHEMIA 1
POOR COAT CONDITION 1
PR-KIDNEY(S), LESION(S) 1
PR-LIVER, LESION(S) 1
PROFUSE BLEEDING 1
PROLONGED ACTIVATED PARTIAL THROMBIN TIME (APTT) 1
PROLONGED ONE STAGE PROTHROMBIN TIME (OSPT) 1
PROPRIOCEPTION DEFICIT 1
PR-PANCREAS, LESION(S) 1
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DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
PR-SMALL INTESTINE, LESION(S) 1
PRURITIC RASH 1
PULMONARY DISORDER NOS 1
RED EYE 1
REDUCED LEVEL OF CONSCIOUSNESS 1
RENAL INSUFFICIENCY 1
RETINAL DEGENERATION 1
ROLLING 1
SCROTAL OEDEMA 1
SELF TRAUMA 1
SEPTICAEMIA 1
SHALLOW BREATHING 1
SICK EUTHYROID SYNDROME 1
SKIN DRYNESS 1
SKIN LESION NOS 1
SKIN PETECHIAE 1
SKIN SLOUGH 1
SKIN TUMOUR NOS 1
SLEEPINESS - SYSTEMIC DISORDER 1
SNEEZING 1
SODIUM:POTASSIUM LOW, BLOOD 1
SORE TONGUE 1
SPASM 1
SPLEEN AND RETICULO-ENDOTHELIAL SYSTEM DISORDER NOS 1
SPLEEN HYPERTROPHY 1
SPLENOMEGALY 1
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Report Version: 1.37
DRUG: FLURALANER
Route of Administration: Species:
ORAL
Dog
Sign : Number of Times Reported :
STAGGERING 1
STEATITIS 1
STERILE 1
STIFF GAIT 1
STOMACH PAIN 1
SYSTEMIC DISORDER NOS 1
TACHYCARDIA 1
TENSE ABDOMEN 1
THORACIC CAVITY DISORDER NOS 1
TITER DATA ABNORMAL 1
TONIC-CLONIC SEIZURE 1
UNABLE TO RISE 1
UNSTEADY GAIT 1
URINARY INCONTINENCE 1
URTICARIA 1
URTICARIAL RASH 1
WHEEZING 1
Route of Administration: Species:
OTHER
Dog
Sign : Number of Times Reported :
ABDOMINAL MASS 1
ABDOMINAL PAIN 1
ABNORMAL ULTRASOUND FINDING 1
ANOREXIA 1
DEATH BY EUTHANASIA 1
DIARRHOEA 1
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Report Version: 1.37
DRUG: FLURALANER
Route of Administration: Species:
OTHER
Dog
Sign : Number of Times Reported :
ENLARGED LIVER 1
FLATULENCE 1
LIVER DISORDER NOS 1
Route of Administration: Species:
TRANSPLACENTAL
Dog
Sign : Number of Times Reported :
CLEFT PALATE 2
BIRTH DEFECT 1
CONGENITAL NEUROLOGICAL DISORDER NOS 1
DEATH 1
DEATH BY EUTHANASIA 1
MALFORMATION NOS 1
STILLBIRTH 1
Route of Administration: Species:
UNKNOWN
Dog
Sign : Number of Times Reported :
UNCLASSIFIABLE ADVERSE EVENT 1
URINARY TRACT DISORDER NOS 1
Route of Administration: Species:
ORAL
Human
Sign : Number of Times Reported :
DIARRHOEA 1
DRY MOUTH 1
INCREASED HEART RATE 1
MALAISE 1
Route of Administration: Species:
TOPICAL
Human
Sign : Number of Times Reported :
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Report Version: 1.37
DRUG: FLURALANER
Route of Administration: Species:
TOPICAL
Human
Sign : Number of Times Reported :
APPLICATION SITE SKIN CHANGE NOS 2
APPLICATION SITE REACTION NOS 1
APPLICATION SITE REDDENING 1
APPLICATION SITE TINGLING 1
FACIAL RASH 1
HIVES 1
LOCALISED ITCHING 1
MALAISE 1
PRODUCT PROBLEM 1
REDDENING OF THE SKIN 1
SKIN DISORDERS NOS 1
SKIN IRRITATION 1
URTICARIAL ERYTHEMA 1
Report Printed on 08-Feb-2017 at 12:13:58PM
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Report Version: 1.37