Potassium bromide: what the FDA reviewed for dog products
2 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Potassium bromide, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- KBROVET® (NADA/ANADA 141-615)
KBROVET® NADA 141-615, Original approval, January 09, 2026; sponsor Pegasus Laboratories, Inc.; species: Dogs; foi_id 17867; FDA PDF
Indication
Control of seizures associated with idiopathic epilepsy in dogs.
Dose regimen
25 to 68 mg/kg (11 to 31 mg/lb) body weight total daily dosage, Oral (250 or 500 mg chewable tablets), Once daily, Adjusted to clinical response; with or without food; an initial loading regimen may be considered on an individual basis; chronic therapy
The total recommended daily dosage range for oral administration is 25 to 68 mg/kg (11 to 31 mg/lb) of body weight once daily.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | mean serum bromide concentration 1.51 (±0.5) mg/mL (range 0.8 to 3.1 mg/mL) | Retrospective dose-determination study PLI-CL017: 284 client-owned dogs on KBr monotherapy, mean total daily oral dose 46.4 (±21.9) mg/kg, mean dose duration 187 days (approaching steady state); therapeutic drug monitoring samples | The mean serum bromide concentration (SBC) in the dogs included in the study was 1.51 (±0.5) mg/mL (range 0.8 to 3.1 mg/mL). |
| other | published therapeutic serum bromide range ≥0.8 and ≤3.5 mg/mL | Target range used for case eligibility (steady-state serum bromide concentrations) | This retrospective evaluation was conducted to determine the total daily oral dose range of potassium bromide (KBr) necessary to achieve serum bromide concentrations (approaching steady-state conditions) that are within 10% of the published therapeutic range (≥0.8 and ≤3.5 mg/mL)1 in dogs with idiopathic epilepsy. |
| other | serum bromide 2.4 to 4 mg/mL in most dogs with toxicosis on monotherapy; some dogs treated without toxicosis at 4 to 4.8 mg/mL | Literature (systematic review, Public Master File); concentration-toxicity relationship | One study found that most dogs that develop signs of toxicoses with bromide monotherapy had serum bromide concentrations in the range of 2.4 to 4 mg/mL, but this study also found that dogs were successfully treated without signs of toxicosis at serum concentrations as high as 4 to 4.8 mg/mL. |
Target-animal safety
The safety of KBROVET® is supported by a Public Master File containing data describing the target animal safety of potassium bromide and the safety information from the two retrospective studies, Study No. PLI-CL008 and PLI-CL013, summarized above under Effectiveness.
| Finding | Quote |
|---|---|
| Reversible neurologic signs are the most consistent toxicosis, generally with adjunctive KBr or high serum bromide | Reversible neurologic signs were the most consistently reported toxicosis and were generally associated with adjunctive potassium bromide treatment or high serum bromide concentrations. |
| Laboratory study: minimal toxicosis at 100 mg NaBr/kg/day for 6 weeks (mean serum 2.7 mg/mL) | In a laboratory study, unspecified minimal signs of toxicosis were found in dogs administered a daily dose of 100 mg of NaBr/kg (45.5 mg/lb/d) for 6 weeks; mean serum concentration was 2.7 mg/mL. |
| Severe bromide intoxication: depression, behavioral changes, ataxia, hind limb paresis, mydriasis, stupor, coma | Signs of more severe bromide intoxication were similar across species (humans, rats, mice, dogs, cattle, and horses) and included signs of depression, behavioral changes, ataxia, hind limb paresis, mydriasis, stupor, and coma. |
| Sterile nodular panniculitis reported (dose dependent, resolves on withdrawal) | Development of sterile nodular panniculitis has been reported in patients receiving potassium bromide. |
| Most common adverse events by body system: neurologic/behavioral, gastrointestinal (incl. pancreatitis), reproductive, endocrine, dermatologic, respiratory; also polyuria/polydipsia | Based on the reviewed articles, the most common adverse drug events reported were found in the neurologic (including behavioral), gastrointestinal (including pancreatitis), reproductive, endocrine, dermatologic, and respiratory systems. |
Effectiveness
Pivotal retrospective, uncontrolled medical-record study (PLI-CL013, Auburn, AL; records 2010-2017) of client-owned dogs on immediate-release oral KBr monotherapy with serum bromide 0.8-3.5 mg/mL; seizure counts in the 30-day baseline vs a 30-day period after at least 60 days at a stable dose; response compared with a published 29% placebo rate; a pilot retrospective study (PLI-CL008, 27 evaluable dogs, 18 successes) and literature are supportive.; n = 46; primary endpoint: Treatment success = at least 50% reduction in seizure frequency from baseline; result: 40 of 46 cases had at least a 50% reduction in seizure frequency. Median maintenance dose 33 mg/kg/day (24.5 to 64); 63% received a loading dose (mean 115 mg/kg/day over 2 to 7 days).
Effectiveness: Between baseline and the 30-day post treatment evaluation, 40 of 46 cases experienced at least a 50% reduction in seizure frequency.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Weight gain | 13/46 | Table II.3. Adverse Reactions Reported During 60-Day Period (n=46) Adverse Reaction Number of Dogs with the Adverse Reaction Weight Gain 13 Vomiting 6 Sedation 3 Increased Appetite 2 Increased Drinking 2 Ataxia 1 | |
| Vomiting | 6/46 | Table II.3. Adverse Reactions Reported During 60-Day Period (n=46) Adverse Reaction Number of Dogs with the Adverse Reaction Weight Gain 13 Vomiting 6 Sedation 3 Increased Appetite 2 Increased Drinking 2 Ataxia 1 | |
| Sedation | 3/46 | Table II.3. Adverse Reactions Reported During 60-Day Period (n=46) Adverse Reaction Number of Dogs with the Adverse Reaction Weight Gain 13 Vomiting 6 Sedation 3 Increased Appetite 2 Increased Drinking 2 Ataxia 1 | |
| Increased appetite | 2/46 | Table II.3. Adverse Reactions Reported During 60-Day Period (n=46) Adverse Reaction Number of Dogs with the Adverse Reaction Weight Gain 13 Vomiting 6 Sedation 3 Increased Appetite 2 Increased Drinking 2 Ataxia 1 | |
| Increased drinking | 2/46 | Table II.3. Adverse Reactions Reported During 60-Day Period (n=46) Adverse Reaction Number of Dogs with the Adverse Reaction Weight Gain 13 Vomiting 6 Sedation 3 Increased Appetite 2 Increased Drinking 2 Ataxia 1 |
Extraction notes: Full (non-conditional) original approval of NADA 141-615 following the KBroVet-CA1 conditional approval. All effectiveness evidence is retrospective and uncontrolled (no placebo group); the pilot study's adverse reaction tables (n=51; increased appetite 11, weight gain 8, vomiting 5, regurgitation 4, sedation 3 in the first 60 days) are not tabulated here. No margin-of-safety (dose-multiple) study: target animal safety rests on the Public Master File systematic literature review (Baird-Heinz 2012) plus the retrospective studies. 'PK' entries are serum bromide concentration data (no classical PK parameters reported). Adverse reaction table quoted as flattened text (Adverse Reaction, Number of Dogs).
KBROVET® NADA 141-615, Original approval, January 14, 2021; sponsor Pegasus Laboratories, Inc.; species: Dogs; foi_id 18237; FDA PDF
Indication
Control of seizures associated with idiopathic epilepsy in dogs (conditional approval).
Dose regimen
25-68 mg/kg (11-31 mg/lb) body weight total daily dosage, Oral (250 or 500 mg chewable tablets), Once daily, Adjusted to clinical response; with or without food; initial loading regimen may be considered on an individual basis; chronic therapy
The total recommended daily dosage range for oral administration is 25-68 mg/kg (11-31 mg/lb) of body weight once daily.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | mean serum bromide concentration 1.51 (± 0.5) mg/mL (range 0.8-3.1 mg/mL) | Retrospective dose-determination study PLI-CL017: 284 client-owned dogs on KBr monotherapy, mean total daily oral dose 46.4 mg/kg, mean dose duration 187 days (approaching steady state); therapeutic drug monitoring database | The mean SBC resulting from the indicated KBr doses, duration, and intervals was 1.51 (± 0.5) mg/mL (range 0.8-3.1 mg/mL). |
| other | published therapeutic serum bromide range ≥0.8 and ≤3.5 mg/mL | Literature target range for dogs with idiopathic epilepsy | The published therapeutic range for KBr for treating dogs with idiopathic epilepsy is (≥0.8 and ≤3.5 mg/mL). |
| other | total daily oral dose range 43.8-48.9 mg/kg (95% confidence limits of the case population); mean 46.4 (± 21.9) mg/kg, one-SD range 24.5-68.3 mg/kg | Dose-concentration relationship from PLI-CL017 (284 dogs) used to derive the label dose range | Based on upper and lower 95% confidence limits for the case population, the total daily oral dose range was 43.8-48.9 mg KBr per kg bodyweight. From this analysis the mean total daily oral dose was 46.4 (± 21.9) mg/kg; the dose range with one standard deviation was 24.5-68.3 mg/kg. |
Target-animal safety
The safety of KBroVet®-CA1 is supported by a Public Master File containing data describing the target animal safety of potassium bromide and the safety information from the pilot retrospective study, Study No. PLI-CL008, summarized above under Reasonable Expectation of Effectiveness.
| Finding | Quote |
|---|---|
| Reversible neurologic signs are the most consistent toxicosis, generally with adjunctive KBr or high serum bromide | Reversible neurologic signs were the most consistently reported toxicosis and were generally associated with adjunctive potassium bromide treatment or high serum bromide concentrations. |
| Toxicosis mostly at serum bromide 2.4 to 4 mg/mL on monotherapy; some dogs tolerated 4 to 4.8 mg/mL | One study found that most dogs that develop signs of toxicoses with bromide monotherapy had serum bromide concentrations in the range of 2.4 to 4 mg/mL, but this study also found that dogs were successfully treated without signs of toxicosis at serum concentrations as high as 4 to 4.8 mg/mL. |
| Laboratory study: minimal toxicosis at 100 mg NaBr/kg/day for 6 weeks (mean serum 2.7 mg/mL) | In a laboratory study, unspecified minimal signs of toxicosis were found in dogs administered a daily dose of 100 mg of NaBr/kg (45.5 mg/lb/d) for 6 weeks; mean serum concentration was 2.7 mg/mL. |
| Severe bromide intoxication: depression, behavioral changes, ataxia, hind limb paresis, mydriasis, stupor, coma | Signs of more severe bromide intoxication were similar across species (humans, rats, mice, dogs, cattle, and horses) and included signs of depression, behavioral changes, ataxia, hind limb paresis, mydriasis, stupor, and coma. |
| Dogs with decreased renal function may be predisposed to bromide toxicosis | Animals with decreased renal function may be predisposed to bromide toxicosis owing to a decreased ability to eliminate bromide as a result of reduced glomerular filtration rate. |
Effectiveness
Retrospective pilot medical-record study (PLI-CL008, Auburn, AL, cases 2005-2010) of client-owned dogs on immediate-release oral KBr monotherapy with serum bromide 0.8-3.5 mg/mL; 51 evaluable cases (27 valid for effectiveness, 24 safety only); seizure count, seizure event days and severity in the 30 days before KBr vs 30 days at steady-state dosing (same dose for at least 60 days); uncontrolled, descriptive statistics.; n = 27; primary endpoint: Treatment success = at least 50% decrease in seizure count and in seizure event days plus no increase in seizure severity score; result: 18 of 27 (67%) treatment successes, 9 (33%) failures; seizure count success 19/27 (70%), seizure event day success 18/27 (67%); severity decreased or unchanged in 25/27. Mean maintenance dose 37 mg/kg/day (effectiveness dataset).
Overall, of the 27 dogs included in the effectiveness analysis, 18 (67%) were considered treatment successes and 9 (33%) were considered treatment failures.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Increased appetite (initial 60-day dosing phase) | 11 | Increased Appetite 11 Weight Gain 8 Vomiting 5 Regurgitation 4 Sedation 3 | |
| Weight gain (initial 60-day dosing phase) | 8 | Increased Appetite 11 Weight Gain 8 Vomiting 5 Regurgitation 4 Sedation 3 | |
| Vomiting (initial 60-day dosing phase) | 5 | Increased Appetite 11 Weight Gain 8 Vomiting 5 Regurgitation 4 Sedation 3 | |
| Regurgitation (initial 60-day dosing phase) | 4 | Increased Appetite 11 Weight Gain 8 Vomiting 5 Regurgitation 4 Sedation 3 | |
| Sedation (initial 60-day dosing phase) | 3 | Increased Appetite 11 Weight Gain 8 Vomiting 5 Regurgitation 4 Sedation 3 |
Extraction notes: Summary is for conditional approval application 141-544 (KBroVet®-CA1), catalogued under NADA 141-615. Adverse reactions are counts of dogs from Table II.1 (60-day period after start of KBr therapy) among the 51 cases in the safety evaluation; the table header lacks the denominator so treated is given as a count. A second table (30-day steady-state period: weight gain 7, weakness 5, ataxia 4, increased appetite 4) is not tabulated. No margin-of-safety study; TAS rests on the Public Master File systematic review. 'PK' entries are serum bromide concentration/dose data, not classical PK parameters.
Reproduce: foi_structured_search(query="Potassium bromide") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).