Filaribits® Plus Chewable Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Filaribits® Plus Chewable Tablets

Active ingredient

Diethylcarbamazine Citrate Oxibendazole

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

1,481

Reports mentioning this ingredient

January 9, 1987 – October 26, 2004

0

Classified serious

per reporter assessment

93

Lack of expected efficacy

resistance signal

153

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 “DIETHYLCARBAMAZINE, OXIBENDAZOLE”. 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	291
Elevated alanine aminotransferase (ALT)	251
Elevated serum alkaline phosphatase (SAP)	220
Anorexia	187
Depression	176
No sign	162
INEFFECTIVE, HEARTWORM LARVAE	160
Accidental exposure	153
UNPALATABLE	120
Death	117
Diarrhoea	101
PR-LIVER, LESION(S)	99
Elevated total bilirubin	98
Elevated aspartate aminotransferase (AST)	96
Icterus	91
Lack of efficacy (endoparasite) - hookworm	74
Weight loss	57
Elevated liver enzymes	55
Hypoalbuminaemia	50
Leucocytosis NOS	46

Species affected

Source: openFDA VeDDRA

Dog 1,276 Human 37 Cat 28 Other 2

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