Sulfodene® Medication for Dogs — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Sulfodene® Medication for Dogs

Active ingredient

2-Mercaptobenzothiazole

Application type

NADA

Sponsor

Farnam Companies, Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

22

Reports mentioning this ingredient

February 27, 2013 – October 5, 2018

1

Classified serious

per reporter assessment

2

Lack of expected efficacy

resistance signal

9

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 “2-MERCAPTOBENZOTHIAZOLE”. 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
Accidental exposure	9
Vomiting	5
Accidental drug intake by child	4
Lethargy (see also Central nervous system depression in 'Neurological')	3
Anorexia	3
No sign	3
Licking at application site	2
Incorrect route of drug administration	2
Haematuria	1
Disorientation	1
Impaired vision	1
Emesis (multiple)	1
Diarrhoea	1
Application site alopecia	1
Application site reddening	1
Alopecia local	1
Erythema (for urticaria see Immune SOC)	1
Pruritus	1
Stinging skin	1
Unthrifty	1

Species affected

Source: openFDA VeDDRA

Dog 14 Human 7 Cat 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