Dichlorvos: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Dichlorvos, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs, puppies, cats and kittens (supplement adds kittens not less than three months of age and adult dogs).
Products
- Task® Tabs (NADA/ANADA 048-271)
Task® Tabs NADA 048-271, Supplemental approval, March 04, 1999; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs, puppies, cats and kittens (supplement adds kittens not less than three months of age and adult dogs); foi_id 311; FDA PDF
Indication
Removal and control of roundworms (Toxocara canis, Toxocara cati, Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma tubaeforme, Uncinaria stenocephala) in dogs, puppies, cats and kittens.
Dose regimen
5 mg dichlorvos per pound body weight, oral (tablet), single dose
TASK® Tabs are administered as a single dose to provide 5 mg dichlorvos per pound body weight to dogs, puppies, cats and kittens.
Target-animal safety
dose multiples 1X (250 mg once), 2X (250 mg twice in one day), 5X (500 mg once); duration single day; animals 15.
This study included 15 dogs over 60 pounds. Five geriatric dogs (over 7 years of age) were included in the study. Ten adult dogs (between 1 and 7 years of age) were included in the study.
| Finding | Quote |
|---|---|
| No adverse reactions in adult and geriatric dogs at up to 5X | There were no adverse reactions in noted in this study. |
| Effectiveness and safety demonstrated in adult and geriatric dogs at doses up to 5X | The study demonstrated the effectiveness and safety of Task Tabs in adult and geriatric dogs when administered at doses up to 5X. |
Effectiveness
Multi-investigator (14 sites) clinical field study of 5 mg/lb single oral dose in adult dogs; eggs-per-gram reduction and parasite clearance rates; plus a critical (necropsy) test in 25 young adult Beagles and a 12-site field study in 43 kittens 3-5 months old; n = 171 (roundworm infections); 124 (hookworm infections); primary endpoint: Parasite clearance rate (egg counts to zero) and EPG reduction rate; result: Dogs: roundworms cleared 157/171 (91.2%), EPG 549 to 17 (96.9%); hookworms cleared 114/124 (91.9%), EPG 348 to 16 (95.4%). Critical test: T. canis 141/141 (100%), T. leonina 213/292 (73%), A. caninum 147/151 (97.4%) expelled. Kittens: 91% clearance for both roundworms and hookworms
In this study, 171 dogs were treated for roundworm infections and 124 dogs were treated for hookworm infections.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Cholinergic signs (vomiting, excessive salivation, pupillary contraction, dyspnea, watery diarrhea, muscle fasciculations, abdominal pain, ataxia, general weakness) | The most common adverse reactions recorded were vomiting, excessive salivation, pupillary contraction, dyspnea, watery diarrhea, muscle fasciculations, abdominal pain, ataxia, and general weakness. |
Extraction notes: Supplemental approval (1999) extending use to kittens >= 3 months and adult dogs and adding 10 and 20 mg tablet sizes; data from the 1973 original approval were re-evaluated. No pharmacokinetic content (the batch plan's PK-sentence count reflects 'clearance rate' wording). Adverse reaction counts are not given in the summary. The TAS entry is Clinical Study 1 (dose-multiple study in 15 large dogs); doses are described as approximating 1X, 2X and 5X.
Reproduce: foi_structured_search(query="Dichlorvos") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).