Vercom Paste Anthelmintic — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Vercom Paste Anthelmintic

Active ingredient

Febantel Praziquantel

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

July 10, 2017

Adverse event reports

Source: openFDA VeDDRA

538

Reports mentioning this ingredient

January 30, 1996 – October 4, 2016

0

Classified serious

per reporter assessment

16

Lack of expected efficacy

resistance signal

15

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 “FEBANTEL, PRAZIQUANTEL, PYRANTEL PAMOATE”. 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
Vomiting	285
Depression	69
Diarrhoea	65
Hyperactivity	50
Anorexia	46
Death	45
Tablets, Abnormal	25
Ataxia	24
Convulsion	22
Vocalisation	20
Restlessness	20
Hypersalivation	18
Accidental exposure	15
Pruritus	13
Pacing	13
Anaphylaxis	13
Bloody diarrhoea	12
Underfilling, Package	12
Polypnoea	11
Fever	11

Species affected

Source: openFDA VeDDRA

Dog 469 Cat 15 Human 4

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