Spotton 20% Ready-to-Use Cattle Insecticide — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Spotton 20% Ready-to-Use Cattle Insecticide

Active ingredient

Fenthion

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

234

Reports mentioning this ingredient

March 17, 1987 – January 21, 2011

1

Classified serious

per reporter assessment

31

Lack of expected efficacy

resistance signal

6

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “FENTHION”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Death	41
Vomiting	25
Hypersalivation	24
INEFFECTIVE, GRUBS	24
Depression	22
Trembling	22
Lack of efficacy (ectoparasite) - lice	20
Anorexia	18
Diarrhoea	17
Vials, Leaking	17
Skin lesion NOS	15
Containers, Abnormal	15
Alopecia NOS	14
Ataxia	13
Weakness	10
Lack of efficacy (ectoparasite) - flea	9
Unclassifiable adverse event	8
Recumbency	8
Bloody diarrhoea	7
Accidental exposure	6

Species affected

Source: openFDA VeDDRA

Dog 95 Cattle 75 Cat 10 Human 7 Eagle 1 Other 1

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient