Lincomycin - Spectinomycin — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Lincomycin - Spectinomycin

Active ingredient

Lincomycin Hydrochloride Monohydrate Spectinomycin dihydrochloride pentahydrate

Application type

ANADA

Sponsor

Phibro Animal Health Corp.

Applications on record

1

First published

January 3, 2017

Adverse event reports

Source: openFDA VeDDRA

226

Reports mentioning this ingredient

January 12, 1989 – May 10, 2011

0

Classified serious

per reporter assessment

4

Lack of expected efficacy

resistance signal

0

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 “LINCOMYCIN HYDROCHLORIDE MONOHYDRATE, SPECTINOMYCIN SULFATE TETRAHYDRATE”. 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	172
Dyspnoea	71
PR-LUNG(S), LESION(S)	58
Hypersalivation	45
Foam in the nose	33
Recumbency	29
Diarrhoea	25
Depression	19
Contamination NOS	14
Trembling	11
Weakness	11
Anaphylaxis	11
Staggering	10
Shock	8
Unclassifiable adverse event	8
Death by euthanasia	8
Ataxia	8
PR-HEART, LESION(S)	8
Convulsion	7
PR-PLEURAL EFFUSION	6

Species affected

Source: openFDA VeDDRA

Cattle 190 Quail 3 Pig 2 Duck 1 Human 1 Chicken 1 Sheep 1 Other Birds 1 Other Deer 1 Turkey 1

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

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