Attapulgite, Bismuth Subcarbonate, Kanamycin Sulfate: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Attapulgite, Bismuth Subcarbonate, Kanamycin Sulfate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Amforol® Veterinary Oral Tablets (NADA/ANADA 042-841)
Amforol® Veterinary Oral Tablets NADA 042-841, Supplemental approval, February 21, 1991; sponsor Zoetis Inc.; species: Dogs; foi_id 2543; FDA PDF
Indication
Treatment of bacterial enteritis caused by susceptible strains of E. coli, Salmonella, Shigella, Alcaligenes faecalis, Proteus spp. and Staphylococcus aureus (stated in Agency Conclusions; summary spelling 'suspectible' preserved)
Target-animal safety
Removal of aminopentamide increases the safety of Amforol. The reformulation is supported by substantial evidence of safety and effectiveness as found in the veterinary and human medical literature.
| Finding | Quote |
|---|---|
| Adverse reaction report: CNS dysfunction in two dogs after Amforol Suspension at the recommended dose | An adverse reaction reported central nervous system disfunction in two dogs after use of Amforol Suspension at the recommended dose. |
| Oral kanamycin poorly absorbed through intact mucosa; increased absorption possible through ulcerated areas | Orally administered kanamycin sulfate is generally considered to be poorly absorbed systemically through intact intestinal mucosa, although the possibility of increased absorption through ulcerated or denuded areas should be considered especially when the dose is increased. |
| Attapulgite and pectin not reported to produce toxicity | Activated attapulgite (aluminum magnesium silicate) and pectin when orally administered have not been reported to produce toxicity. |
Effectiveness
Supplemental approval for a reformulation removing aminopentamide hydrogen sulfate; literature-based, no new studies; result: Removal of subtherapeutic aminopentamide not expected to affect efficacy; reformulated product supported by literature and original approval data
The removal of aminopentamide hydrogen sulfate which was present at subtherapeutic levels will not have an adverse effect on the products's efficacy.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Central nervous system dysfunction (two dogs, Amforol Suspension, recommended dose; adverse reaction report) | An adverse reaction reported central nervous system disfunction in two dogs after use of Amforol Suspension at the recommended dose. |
Extraction notes: 1991 supplemental FOI for reformulation; no dosage regimen, no Species/Class field (text refers to 'the dog'/'Dogs'), and no studies. Target-animal-safety section is a literature review (design_quote is the agency's literature statement, not a study design). Indication quoted from the Agency Conclusions; established name in this summary lists kanamycin, pectin, bismuth subcarbonate and activated attapulgite.
Reproduce: foi_structured_search(query="Attapulgite, Bismuth Subcarbonate, Kanamycin Sulfate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).