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BROMADIOLONE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Bromadiolone is a derivative of 4-Hydroxycoumarin, and has anticoagulant properties.

Specific Substances

    1) Bromadiolona
    2) CAS 28772-56-7
    1.2.1) MOLECULAR FORMULA
    1) C30-H23-Br-O4

Available Forms Sources

    A) FORMS
    1) Bromadiolone is an off-white powder solid.
    B) SOURCES
    1) Bromadiolone is a derivative of 4-HYDROXYCOUMARIN (EPA, 1985).
    C) USES
    1) It is used as a rodenticide because of its anticoagulant properties (Budavari, 1989). In this respect, it is similar to WARFARIN. Bromadiolone is an EXTREMELY TOXIC SUBSTANCE.

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Used as a rodenticide.
    B) TOXICOLOGY: Bromadiolone, as a long-acting anticoagulant, blocks the formation of the active form of vitamin K, which in turn inhibits the hepatic production of coagulation factors II, VII, IX, and X. Specifically, it inhibits the subunit 1 of the vitamin K epoxide reductase complex. Primary concern is development of a bleeding diathesis.
    C) EPIDEMIOLOGY: Exposure to long-acting anticoagulants is common, but serious poisoning is rare and generally only occurs after deliberate ingestion. Significant coagulopathy has not been reported after inadvertent exposure in children.
    D) WITH POISONING/EXPOSURE
    1) MILD TO MODERATE TOXICITY: Usually asymptomatic or minimal bleeding issues such as easy bruising.
    2) SEVERE TOXICITY: Nearly always results from an intentional ingestion. Patients may develop a severe bleeding diathesis that can last for months despite treatment, which places the patient at higher risk for life-threatening bleeding complications including gastrointestinal bleeding, intracranial bleeding, hematuria, and intraabdominal or retroperitoneal bleeding.
    0.2.20) REPRODUCTIVE
    A) No reproductive studies were found for bromodiolone, but spontaneous abortion occurred in a case of brodifacoum ingestion. Some coumarin derivatives, principally warfarin, are known human teratogens.
    0.2.21) CARCINOGENICITY
    A) At the time of this review, no data were available to assess the carcinogenic potential of this agent.

Laboratory Monitoring

    A) Laboratory monitoring is not needed if it is a recent, asymptomatic, unintentional exposure.
    B) For symptomatic patients or those with deliberate ingestions, obtain an INR (note: INR may be normal for 24 to 48 hours after a single acute ingestion). Obtain a CBC in patients with evidence of bleeding or coagulopathy, type and cross match for patients with significant bleeding.
    C) In patients with severe bleeding and/or significant coagulopathy frequent determination of INR and CBC may be necessary to guide administration of blood products and vitamin K1.
    D) Specific assays do exist for some long acting anticoagulants and may be useful to identify occult ingestions but they are only available from specialty laboratories and are not helpful in guiding clinical management.
    E) In patients taking therapeutic anticoagulants who are exposed to any dose of long-acting anticoagulant rodenticide (LAAR), obtain a baseline prothrombin time measurement and a repeat measurement 48 to 72 hours after ingestion.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Most unintentional ingestions (e.g., children under the age of 6) need no intervention. Asymptomatic low-grade elevation of the INR can be monitored. Significant prolongation of the INR (greater than 2.0) should be treated with vitamin K.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) If life-threatening bleeding occurs, rapidly reverse coagulopathy with fresh frozen plasma (FFP) or prothrombin complex concentrate. Long-term treatment includes vitamin K, which can be given intravenously or subcutaneously initially, then orally once the patient stabilizes. Long term vitamin K administration (weeks to months) is usually required.
    C) DECONTAMINATION
    1) PREHOSPITAL: Activated charcoal can be useful if given early after large, deliberate ingestions. If there is dermal or eye exposure, it would be reasonable for simple decontamination with water at home. Inadvertent, exploratory ingestions in young children do not require GI decontamination.
    2) HOSPITAL: Activated charcoal may be useful if given early after a large, deliberate ingestion. Neither gastric lavage nor whole bowel irrigation is indicated.
    D) AIRWAY MANAGEMENT
    1) Respiratory complications are not expected. Endotracheal intubation may be required in patients with intracranial bleeding or in rare patients with severe hemoptysis.
    E) ANTIDOTE
    1) Give vitamin K1 (phytonadione) in order to reverse coagulopathy, though the effect is delayed compared to giving blood products. In an unstable patient, intravenous (increased risk of anaphylactoid reactions) or subcutaneous dosing may be preferred; switch to oral dosing once patient has stabilized. For patients with severe coagulopathy, an initial dose of 20 to 40 mg vitamin K is reasonable, with further dosing guided by INR monitoring. Long acting anticoagulants have increased stability and longer duration of action than standard medicinal anticoagulants. Initial vitamin K doses for treatment can be as high as 400 mg with 500 to 1000 mg oral doses for daily maintenance. The long acting anticoagulants can cause a persistent coagulopathy for months but also must rule out repeated ingestions/exposure in these patients.
    F) TRANSFUSION
    1) Administer fresh frozen plasma and/or prothrombin complex concentrate (contains factors II, VII, IX, and X), in addition to vitamin K1, to rapidly reverse coagulopathy in patients with life-threatening bleeding. Monitor INR to determine need for further therapy. Transfusion with packed red blood cells and platelets may also be necessary.
    G) COAGULATION FACTOR VII
    1) Recombinant activated factor VII 70 to 90 mcg/kg IV has been used along with vitamin K1 to rapidly reverse coagulopathy in several cases.
    H) ENHANCED ELIMINATION
    1) Hemodialysis is not indicated.
    I) PATIENT DISPOSITION
    1) HOME CRITERIA: In asymptomatic patients with questionable or unintentional exposure, monitor for easy bruising and bleeding from gums while brushing teeth, otherwise follow up with their personal physician as needed. Patients who inadvertently ingest less than 1 mg of a long-acting anticoagulant rodenticide (LAAR) active ingredient (ie, brodifacoum, bromadiolone, chlorophacinone, difenacoum, and diphacinone) can be observed at home without laboratory monitoring. This amount of active ingredient would include nearly all unintentional ingestions among children less than 6 years of age. However, not all rodenticides are long acting anticoagulants so it is important to identify the specific active ingredient in the commercial product (call the local poison center).
    2) OBSERVATION CRITERIA: The delayed onset and prolonged duration of effect make SHORT TERM observation unlikely to be useful. Patients with deliberate overdose or abuse, with chronic ingestion of LAARs, or with symptoms (eg, bleeding, bruising) should be sent to a healthcare facility for evaluation. Patients taking therapeutic anticoagulants who are exposed to any dose of LAAR should have a baseline prothrombin time measured and obtain a repeat measurement 48 to 72 hours after ingestion. Asymptomatic patients inadvertently exposed to 1 mg or more of active ingredient LAAR should be evaluated for coagulopathy 48 to 72 hours after ingestion. Pregnant women with inadvertent exposures to less than 1 mg of LAAR active ingredient should be evaluated by an obstetrician or primary care provider on an outpatient basis. Stable patients with mild toxicity (INR less than 2) are managed as outpatients.
    3) ADMISSION CRITERIA: Any patient with active bleeding with a bleeding diathesis should be admitted until the bleeding has stopped and the bleeding diathesis is reversed (unless there is a situation where the patient needs to be maintained on some baseline anticoagulation such as transplanted or artificial heart valve). Depending on the patient's social situation, most patients should be admitted for observation until their bleeding diathesis is improved even if there is no active bleeding.
    4) CONSULT CRITERIA: Consult a medical toxicologist or poison center for any patient with a significantly increased INR, active bleeding or other complications. Any patient with a deliberate ingestion should have a psychiatric evaluation.
    J) PITFALLS
    1) Not all rodenticides are long acting anticoagulants. Coagulopathy will not start developing until 24 to 48 hours after an acute ingestion. Coagulopathy may be delayed despite treatment due to the long half-life of these substances. Vitamin K1 is most safely given orally as there have been reports of anaphylactoid reactions from IV administration and hematoma formations from IM injections. Unintentional, one-time ingestions rarely require intervention. Consider child abuse/Munchausen’s syndrome in children with coagulopathy.
    K) PHARMACOKINETICS
    1) Repeated exposure to bromadiolone, a 4-hydroxycoumarin, showed elimination kinetics of a two-compartment model with an estimated half-life of 6 days in the initial phase of elimination followed by a slower termination phase half-life of 10 to 13 days.
    L) DIFFERENTIAL DIAGNOSIS
    1) Bleeding diathesis: DIC, Vitamin K deficiency, rattlesnake envenomation, congenital bleeding disorders (hemophilia, von Willebrand’s disease), or coumadin overdose.

Range Of Toxicity

    A) TOXICITY: Inadvertent ingestions of less than one box of bait rarely cause clinical or laboratory coagulopathy. Patients have survived oral doses of other coumarin derivatives in the 100 to 250 mg range. Patients inadvertently exposed to 1 mg or more of active ingredient long-acting anticoagulant rodenticides (LAARs) should be evaluated for coagulopathy 48 to 72 hours after ingestion.
    B) The World Health Organization (WHO) has classified bromadiolone, technical grade, as pesticide class IA (extremely hazardous).

Clinical Effects

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) VOMITING
    1) WITH POISONING/EXPOSURE
    a) Spontaneous emesis and hemoptysis may occur (Smolinske et al, 1989; HSDB , 1999).
    B) GASTROINTESTINAL HEMORRHAGE
    1) WITH POISONING/EXPOSURE
    a) Gastrointestinal bleeding may develop in patients with coagulopathy (Olmos & Lopez, 2007; Kruse & Carlson, 1992; Sheen et al, 1994).
    C) GASTROINTESTINAL TRACT FINDING
    1) WITH POISONING/EXPOSURE
    a) ORAL ROUTE: Bromadiolone is known to be poisonous by the oral route (EPA, 1985). Because of its high toxicity, however, it is likely to be hazardous by other routes of exposure.

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) BLOOD IN URINE
    1) WITH POISONING/EXPOSURE
    a) Hematuria is a common presenting complaint in adults with coagulopathy from massive ingestion (Hollinger & Pastoor, 1993; Butcher et al, 1992; Sheen et al, 1994; Rauch et al, 1994; Ross et al, 1992; Tecimer & Yam, 1997).
    B) FINDING OF VAGINAL BLEEDING
    1) WITH POISONING/EXPOSURE
    a) Excessive vaginal bleeding may develop in women (Chow et al, 1992; Routh et al, 1991; Barnett et al, 1992).

Hematologic

    3.13.2) CLINICAL EFFECTS
    A) HEMORRHAGE
    1) WITH POISONING/EXPOSURE
    a) Hemorrhage is the most common toxic sign and may be manifested by epistaxis, gum bleeding, hemoptysis, hematuria, gastrointestinal bleeding, ecchymoses, bloody or melenotic stools, bruising, and abdominal and flank pain.
    b) ONSET OF SIGNS/SYMPTOMS: While the onset of prolonged prothrombin times occurs generally within 48 hours, the first clinical signs of bleeding may be delayed until one to four weeks after ingestion (Burucoa et al, 1989a; Ross et al, 1992).
    B) BLOOD COAGULATION PATHWAY FINDING
    1) WITH POISONING/EXPOSURE
    a) The long acting anticoagulants reduce the serum concentrations of the vitamin K defendant clotting factors (II, VII, IX and X), resulting in prolongation of INR, PT and PTT (Chow et al, 1992; Ross et al, 1992). Platelet count, fibrinogen level, and the concentrations of other clotting factors remain unaffected (Babcock et al, 1993). Fibrin split products may be elevated (Routh et al, 1991).
    b) ONSET: Prolonged prothrombin time may be evident within 24 hours of ingestion and maximal in 36 to 72 hours. Larger doses produce a more rapid prolongation of PT than smaller doses (Leck & Park, 1981).
    c) DURATION: In overdose, PT prolongation and clinical bleeding have persisted for 45 days to 14 months (Sarin et al, 2005; La Rosa et al, 1997; Kruse & Carlson, 1992; Lipton & Klass, 1984; Murdoch, 1983; Barlow et al, 1982) . Surreptitious reexposure likely occurred in many of these patients.
    d) Prolonged hypocoagulability has been shown to occur with ingestion of bromadiolone (Greeff et al, 1987; Chataigner et al, 1989). In one pediatric case of acute poisoning, prolonged prothrombin time was still in evidence approximately one month after exposure (Greeff, 1988).
    e) These anticoagulants cause a more effective block of the vitamin K 1 epoxide cycle than warfarin. They block vitamin K-dependent clotting factor synthesis by inhibiting the K 1-2,3-epoxide reductase enzyme. It has been suggested that they bind more strongly to the liver than warfarin, resulting in more persistent effects (Hadler & Shadbolt, 1975).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) PURPURA
    1) WITH POISONING/EXPOSURE
    a) Multiple ecchymoses and hematomas may be evident on physical examination (Exner et al, 1992; Babcock et al, 1993; Chow et al, 1992; Rauch et al, 1994; Palmer et al, 1999).

Reproductive

    3.20.1) SUMMARY
    A) No reproductive studies were found for bromodiolone, but spontaneous abortion occurred in a case of brodifacoum ingestion. Some coumarin derivatives, principally warfarin, are known human teratogens.
    3.20.2) TERATOGENICITY
    A) CONGENITAL ANOMALY
    1) At the time of this review, no human data were available to assess the teratogenic potential of bromadiolone.
    2) CASE REPORTS
    a) Some coumarin anticoagulants, primarily WARFARIN, have been linked with human birth defects. Characteristic skeletal defects, called FETAL WARFARIN SYNDROME, arise when exposure is during the first trimester (Schardein, 1993).
    b) Hypoplastic nose, often flattened and sunken into the face, radiological stippling of the spinal column, and punctate calcification are characteristic effects of exposure during the first trimester (Schardein, 1993).
    c) Central nervous system defects, including hydrocephaly and microcephaly, are linked with exposure during the second or third trimester (Schardein, 1993).
    d) The risk of malformation when a pregnant woman is exposed to therapeutic levels of coumarin anticoagulants appears to be approximately 1 in 3 (Schardein, 1993). Risks from high acute exposures are not known.
    3.20.3) EFFECTS IN PREGNANCY
    A) ABORTION
    1) CASE REPORT
    a) Spontaneous abortion was reported in a 31-year-old woman who ingested 1500 g of Talon(R) (containing 75 mg of brodifacoum) five weeks earlier (Lipton & Klass, 1984).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS28772-56-7 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed
    3.21.2) SUMMARY/HUMAN
    A) At the time of this review, no data were available to assess the carcinogenic potential of this agent.
    3.21.3) HUMAN STUDIES
    A) LACK OF INFORMATION
    1) At the time of this review, no data were available to assess the carcinogenic potential of this agent.

Summary Of Exposure

    A) USES: Used as a rodenticide.
    B) TOXICOLOGY: Bromadiolone, as a long-acting anticoagulant, blocks the formation of the active form of vitamin K, which in turn inhibits the hepatic production of coagulation factors II, VII, IX, and X. Specifically, it inhibits the subunit 1 of the vitamin K epoxide reductase complex. Primary concern is development of a bleeding diathesis.
    C) EPIDEMIOLOGY: Exposure to long-acting anticoagulants is common, but serious poisoning is rare and generally only occurs after deliberate ingestion. Significant coagulopathy has not been reported after inadvertent exposure in children.
    D) WITH POISONING/EXPOSURE
    1) MILD TO MODERATE TOXICITY: Usually asymptomatic or minimal bleeding issues such as easy bruising.
    2) SEVERE TOXICITY: Nearly always results from an intentional ingestion. Patients may develop a severe bleeding diathesis that can last for months despite treatment, which places the patient at higher risk for life-threatening bleeding complications including gastrointestinal bleeding, intracranial bleeding, hematuria, and intraabdominal or retroperitoneal bleeding.

Heent

    3.4.5) NOSE
    A) WITH POISONING/EXPOSURE
    1) EPISTAXIS may develop in patients with anticoagulant effects (Laposata et al, 2007; Spiller et al, 2003; Chow et al, 1992; Travis et al, 1993; Kruse & Carlson, 1992).
    3.4.6) THROAT
    A) WITH POISONING/EXPOSURE
    1) GINGIVAL BLEEDING: Bleeding from the gingiva may develop in patients with anticoagulant effects (Laposata et al, 2007; Tsutaoka et al, 2003; Hollinger & Pastoor, 1993; Butcher et al, 1992; Travis et al, 1993; Sheen et al, 1994; Kruse & Carlson, 1992; Corke, 1997).

Cardiovascular

    3.5.2) CLINICAL EFFECTS
    A) TACHYARRHYTHMIA
    1) WITH POISONING/EXPOSURE
    a) Chest pain and tachycardia may develop secondary to blood loss (Walker & Beach, 2002; Barnett et al, 1992; Travis et al, 1993; Kruse & Carlson, 1992).
    B) HYPOTENSIVE EPISODE
    1) WITH POISONING/EXPOSURE
    a) Hypotension may develop in patients with substantial blood loss from severe anticoagulant effects (Kruse & Carlson, 1992; Morgan & Tomaszewski, 1995; Corke, 1997).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) INTRACRANIAL HEMORRHAGE
    1) WITH POISONING/EXPOSURE
    a) Death due to massive hemorrhage, preceded by headache, loss of consciousness, and seizures, has been described after massive ingestion (Rutovic et al, 2013; Basehore & Mowry, 1987; Helmuth et al, 1989; Kruse & Carlson, 1992; Ornstein et al, 1999).

Genotoxicity

    A) At the time of this review, no data were available to assess the mutagenic or genotoxic potential of this agent.

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Laboratory monitoring is not needed if it is a recent, asymptomatic, unintentional exposure.
    B) For symptomatic patients or those with deliberate ingestions, obtain an INR (note: INR may be normal for 24 to 48 hours after a single acute ingestion). Obtain a CBC in patients with evidence of bleeding or coagulopathy, type and cross match for patients with significant bleeding.
    C) In patients with severe bleeding and/or significant coagulopathy frequent determination of INR and CBC may be necessary to guide administration of blood products and vitamin K1.
    D) Specific assays do exist for some long acting anticoagulants and may be useful to identify occult ingestions but they are only available from specialty laboratories and are not helpful in guiding clinical management.
    E) In patients taking therapeutic anticoagulants who are exposed to any dose of long-acting anticoagulant rodenticide (LAAR), obtain a baseline prothrombin time measurement and a repeat measurement 48 to 72 hours after ingestion.
    4.1.2) SERUM/BLOOD
    A) COAGULATION STUDIES
    1) PROTHROMBIN TIME AND INTERNATIONAL NORMALIZED RATIO (INR) are helpful in diagnosis and monitoring of antidotal therapy. Any prolongation of PT or INR when compared to normal controls indicates toxicity. Prothrombin times and INR may be normal 24 hours postingestion, and become prolonged at 48 hours or later, therefore a 24-hour and a 48-hour PT and INR is recommended (Smolinske et al, 1989). If any prolongation is observed, repeat PT and INR every 6 to 12 hours to assess efficacy of therapy. PTT has also been prolonged in overdose.
    2) FACTOR ASSAYS: Determination of blood clotting factors II, VII, IX, and X may be helpful in guiding therapy in symptomatic patients. Since clotting factors may be abnormal with a normal PT and INR, they are a more sensitive measure of toxicity and may be more useful in guiding vitamin K1 therapy (Hoffman et al, 1988).
    4.1.4) OTHER
    A) OTHER
    1) FECAL
    a) Check for the presence of blood in the stools in symptomatic patients or in patients with a prolonged PT or INR.
    2) OTHER
    a) Most of these products contain a water-soluble dye (usually blue or green). However, evidence of dye in the mouth was not predictive of which children developed a prolonged PT in a prospective study of 110 accidental pediatric ingestions (Smolinske et al, 1989).

Methods

    A) LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY (LC-MS)
    1) In one study, LC-MS was used to quantify bromadiolone in whole blood and plasma. Limits of detection and quantification were 0.005 mg/L and 0.01 mg/L, respectively (Vindenes et al, 2008).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Any patient with active bleeding with a bleeding diathesis should be admitted until the bleeding has stopped and the bleeding diathesis is reversed (unless there is a situation where the patient needs to be maintained on some baseline anticoagulation such as transplanted or artificial heart valve). Depending on the patient's social situation, most patients should be admitted for observation until their bleeding diathesis is improved even if there is no active bleeding.
    B) Coagulopathy commonly persists for 6 weeks or longer in patients who ingest large amounts in suicidal attempts. Premature discharge of such patients at 3 to 4 weeks postingestion prior to full normalization of factor levels has resulted in fatality in 3 cases (Basehore & Mowry, 1987; Helmuth et al, 1989; Kruse & Carlson, 1992).
    C) Frequent outpatient monitoring should be done on patients discharged on oral vitamin K1 to ensure compliance and adequacy of treatment. Factor assays should be normal prior to discontinuation of vitamin K1.
    6.3.1.2) HOME CRITERIA/ORAL
    A) In asymptomatic patients with questionable or unintentional exposure, monitor for easy bruising and bleeding from gums while brushing teeth, but otherwise follow up with their personal physician as needed.
    B) Patients who inadvertently ingest less than 1 mg of a long-acting anticoagulant rodenticide (LAAR) active ingredient (ie, brodifacoum, bromadiolone, chlorophacinone, difenacoum, and diphacinone) can be observed at home without laboratory monitoring. This amount of active ingredient would include nearly all unintentional ingestions among children less than 6 years of age. However, not all rodenticides are long acting anticoagulants so it is important to identify the specific active ingredient in the commercial product (call the local poison center) (Caravati et al, 2007).
    C) Children with a history of a single, acute, unintentional ingestion of less than 1 mg of active ingredient (e.g. less than 20 g or 2/3 oz. net weight of a 0.005% product) can be observed at home without decontamination but with telephone follow-up. Outpatient evaluation of the INR or prothrombin time should be performed in patients with clinical evidence of bleeding (Ingels et al, 2002; Shepherd et al, 2002). Larger or unknown ingestions should prompt consideration of activated charcoal administration, along with clinical and laboratory evaluation (Smolinske et al, 1989; Ingels et al, 2002; Caravati et al, 2007).
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Consult a medical toxicologist or poison center for any patient with a significantly increased INR, active bleeding or other complications. Any patient with a deliberate ingestion should have a psychiatric evaluation.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) The delayed onset and prolonged duration of effect make SHORT TERM observation unlikely to be useful. Patients with deliberate overdose or abuse, with chronic ingestion of long-acting anticoagulant rodenticides (LAARs), or with symptoms (eg, bleeding, bruising) should be sent to a healthcare facility for evaluation. Patients taking therapeutic anticoagulants who are exposed to any dose of LAAR should have a baseline prothrombin time measured and obtain a repeat measurement 48 to 72 hours after ingestion. Asymptomatic patients inadvertently exposed to 1 mg or more of active ingredient LAAR should be evaluated for coagulopathy 48 to 72 hours after ingestion. Pregnant women with inadvertent exposures to less than 1 mg of LAAR active ingredient should be evaluated by an obstetrician or primary care provider on an outpatient basis (Caravati et al, 2007). Stable patients with mild toxicity (INR less than 2) are managed as outpatients and patients with more severe coagulopathy or bleeding are admitted.

Monitoring

    A) Laboratory monitoring is not needed if it is a recent, asymptomatic, unintentional exposure.
    B) For symptomatic patients or those with deliberate ingestions, obtain an INR (note: INR may be normal for 24 to 48 hours after a single acute ingestion). Obtain a CBC in patients with evidence of bleeding or coagulopathy, type and cross match for patients with significant bleeding.
    C) In patients with severe bleeding and/or significant coagulopathy frequent determination of INR and CBC may be necessary to guide administration of blood products and vitamin K1.
    D) Specific assays do exist for some long acting anticoagulants and may be useful to identify occult ingestions but they are only available from specialty laboratories and are not helpful in guiding clinical management.
    E) In patients taking therapeutic anticoagulants who are exposed to any dose of long-acting anticoagulant rodenticide (LAAR), obtain a baseline prothrombin time measurement and a repeat measurement 48 to 72 hours after ingestion.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) SUMMARY
    1) Children with exploratory ingestions of less than a box of bait or less than 1 mg of active ingredient (e.g., less than 20 g or 2/3 oz. net weight of a 0.005% product) rarely develop clinical or laboratory evidence of coagulopathy. Gastrointestinal decontamination is generally not required in these cases (Ingels et al, 2002; Caravati et al, 2007).
    B) ACTIVATED CHARCOAL
    1) PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION
    a) Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).
    1) In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
    2) The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.2) PREVENTION OF ABSORPTION
    A) SUMMARY
    1) Children with exploratory ingestions of less than a box of bait or less than 1 mg of active ingredient (e.g. less than 20 g or 2/3 oz. net weight of a 0.005% product) rarely develop clinical or laboratory evidence of coagulopathy. Gastrointestinal decontamination is generally not required in these cases(Ingels et al, 2002; Caravati et al, 2007). Activated charcoal should be considered for large or deliberate ingestions.
    B) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    C) GASTRIC LAVAGE/NOT RECOMMENDED
    1) Not recommended as it may induce bleeding in adults with significant coagulopathy and is not necessary in children after unintentional ingestion.
    6.5.3) TREATMENT
    A) MONITORING OF PATIENT
    1) Children with exploratory ingestions of less than a box of bait or less than 1 mg of active ingredient (e.g. less than 20 g or 2/3 oz. net weight of a 0.005% product) rarely develop clinical or laboratory evidence of coagulopathy (Ingels et al, 2002; Caravati et al, 2007). They do not require routine laboratory monitoring.
    2) Monitor INR or PT after large or deliberate ingestions. An INR or PT obtained prior to 48 hours post-ingestion may not be predictive of subsequent coagulopathy. A 48 to 72 hour INR/PT is therefore recommended (Smolinske et al, 1989). If any prolongation is observed, repeat INR or PT every 6 to 12 hours to assess efficacy of therapy.
    3) PATIENT CURRENTLY ON THERAPEUTIC ANTICOAGULATION: Get INR or PT immediately. If patient is anticoagulated for prosthetic valve or other procedure requiring absolute anticoagulation, do not give vitamin K unless anticoagulation is excessive. Only a small intravenous dose (1 to 5 mg) titrated to return INR to THERAPEUTIC (not normal) should be utilized. Substitution of heparin as an anticoagulant may be necessary until INR is therapeutic.
    4) In patients taking therapeutic anticoagulants who are exposed to any dose of long-acting anticoagulant rodenticide (LAAR), obtain a baseline prothrombin time measurement and a repeat measurement 48 to 72 hours after ingestion (Caravati et al, 2007).
    5) Follow hematocrit closely, at least a reading every four hours until it is stable.
    6) All stools and vomitus should be Hematest for occult blood.
    B) PHYTONADIONE
    1) VITAMIN K 1 (phytonadione, AquaMEPHYTON(R), Mephyton(R)): is a specific antidote and should be administered to any patient with a prolonged INR/PT. Menadione (Vitamin K 3, Synkayvite(R)) SHOULD NOT be used.
    a) ORAL VITAMIN K INDICATIONS: Oral phytonadione may be indicated in small ingestions or when the amount is uncertain, but presumed to be small. Administer 15 to 25 mg in adults and 5 to 10 mg in children.
    b) ORAL DOSE: Absorption is inconsistent. Large daily maintenance doses (100 to 125 mg/day) were required for prolonged therapy in severe overdose (75 mg of brodifacoum) (1.5 to 8 months) (Lipton & Klass, 1984). 20 to 100 mg/day was adequate to prevent bleeding in 4 adult cases where less amounts were ingested (2.15 to 10 mg) (Jones et al, 1984; Chong et al, 1986; Hoffman et al, 1988; Ross et al, 1992), and in two young children with chronic Bromadine poisoning (Greeff et al, 1987).
    1) Prolonged coagulopathy in a 23-year-old man, who intentionally ingested 4 boxes of rodenticide containing brodifacoum, required treatment with high-dose oral vitamin K1 therapy (300 to 600 mg/day) for 5 months. Compliance may be questionable in patients who require long-term therapy with large doses of vitamin K1 (Tsutaoka et al, 2003).
    c) INTRAVENOUS INJECTION
    1) INTRAVENOUS VITAMIN K INDICATIONS: Intravenous phytonadione is preferable in SEVERE cases where rapid correction is required.
    2) DOSE: Adults: A minimum of 10 mg intravenously diluted in saline or glucose at a rate not exceeding 5 percent of the total dose per minute. In maximally anticoagulated individuals, repeat doses at six to eight hour intervals may be required. Initial intravenous doses of up to 400 mg have been required (Hoffman et al, 1988; Vogel et al, 1988a; Burucoa et al, 1989a) in actively hemorrhaging patients.
    3) ADVERSE EFFECTS: Rapid intravenous infusion may produce flushing, cyanosis, dizziness, hypotension, and bronchoconstriction.
    d) SUBCUTANEOUS INJECTION: May be used for initial reversal in patients with coagulopathy without life threatening bleeding. Maintenance doses of 50 to 100 mg/day were required in an adult who ingested 10 mg of brodifacoum (Hoffman et al, 1988).
    e) INTRAMUSCULAR INJECTION/CASE REPORT: A 21-year-old woman, 37 weeks pregnant, presented with a 1-week history of gross hematuria following inadvertent ingestion of rat poison containing brodifacoum approximately 4 days prior to symptom onset. At the time of presentation, an obstetric ultrasound indicated a live fetus with intracranial hemorrhage. Laboratory data of the patient revealed coagulopathy with prolonged prothrombin and activated partial thromboplastin times and significantly decreased coagulations factors II, VII, IX, and X. The patient was given an initial vitamin K dose of 10 mg IM twice daily, followed by a maintenance dose of 40 mg IM three times daily, as well as IV prothrombin complex and fresh plasma, resulting in improvement in her coagulation parameters, although the neonate was delivered stillborn, with an autopsy revealing hemorrhage of the brain and lungs, and multi-organ autolysis. With continued vitamin K therapy over a period of several months post-presentation, the patient made a complete recovery (Yan et al, 2013).
    f) MENADIONE/MENADIOL: (Vitamin K 3) requires metabolism by the liver to Vitamin K 1. The ability of the liver to utilize menadione in the face of generalized hemorrhagic disease is doubtful. Menadione was ineffective as maintenance therapy in one human overdose (Murdoch, 1983), and as initial parenteral therapy in an acute overdose (Kruse & Carlson, 1992).
    2) DURATION OF THERAPY
    a) Monitoring of serial blood brodifacoum levels has been suggested to determine the duration of oral vitamin K1 therapy in severe cases of brodifacoum poisoning (Bruno et al, 2000). Using the kinetic modeling proposed by Bruno et al, no brodifacoum-associated coagulopathy was noted when levels were below 4 to 10 ng/mL, and this vitamin K1 therapy could be safely discontinued. However, this clinical observation in a single case has not yet been validated; its clinical utility requires further study.
    C) COAGULATION FACTOR VII
    1) CASE SERIES: Four patients with severe coagulopathy from long acting anticoagulant poisoning (INR greater than 7, factor VII activity 0.04 International units or less, [normal 0.7 to 1.2], clinical bleeding) were treated with recombinant activated factor VII. The doses used ranged from 70 to 90 mcg/kg intravenously and intravenous vitamin K 20 to 40 mg was administered at the same time. Clinical bleeding stopped within 20 minutes and laboratory evidence of coagulopathy (PT, INR, APTT and factor VII clotting activity) normalized within 15 minutes of factor VII administration(Zupancic-Salck et al, 2005). Factor VII administration appears to be rapidly effective in reversing long acting anticoagulant induced bleeding and coagulopathy; however, it is quite expensive.
    D) COAGULATION FACTOR IX
    1) CASE REPORT: A 52-year-old man, who presented with an expanding hematoma of the neck region and bleeding of the oral mucosa after intentional ingestion of brodifacoum, was treated with Bebulin(R) VH Immuno (factor IX complex), 2000 units intravenously, and vitamin K. Initially, his laboratory values showed a PT greater than 100 seconds, an INR greater than 98.5, and an aPTT of 111.3 seconds. Following treatment with Bebulin(R) VH Immuno and vitamin K, the patient's PT was less than 12 seconds, and he was subsequently discharged on oral maintenance therapy with vitamin K (Eng & Ramstack, 2001).
    E) TRANSFUSION
    1) There is not a specific therapeutic maneuver other than restoration of prothrombin level to normal if toxicity occurs. Administer fresh frozen plasma and/or factor concentrates in addition to packed red blood cells and vitamin K in patients with active bleeding.
    F) PHENOBARBITAL
    1) Phenobarbital, 100 to 180 mg/day has been administered to adults in an attempt to induce liver microsomal enzymes and hasten metabolism of brodifacoum, but its efficacy has not been proven and it is not routinely recommended (Jones et al, 1984; Lipton & Klass, 1984; Kruse & Carlson, 1992).
    2) Administration of phenobarbital to an adult poisoned with chlorophacinone resulted in a decrease in the apparent elimination half-life from 22.8 days to 5.9 days (Burucoa et al, 1989a).
    3) CASE REPORT: A 33-year-old man ingested 1875 mg of chlorophacinone and, other than a prothrombin index of more than 96% 8 hours post-ingestion and a decrease in the vitamin K-dependent clotting factors 3 days post-ingestion, there were no other toxic effects noted. The patient was treated with IV Vitamin K1, in doses ranging from 50 to 120 mg/day for 17 days, and phenobarbital in doses of 200 mg/day for the first 8 days and then 100 mg/day until day 16. He was discharged 17 days post-admission. (Lagrange et al, 1999). The authors speculated that the higher dose of phenobarbital (200 mg/day) shortened the terminal elimination half-life of chlorophacinone in this patient (3.27 days in this patient compared with 6.5 to 22.8 days in previous case reports) .
    4) In rats pretreated with phenobarbital, hypoprothrombinemia was only partially antagonized (Bachmann & Sullivan, 1983).
    G) TELEPHONE CONSULTATION
    1) NATIONAL PESTICIDE TELECOMMUNICATIONS NETWORK:
    a) The National Pesticide Information Center (NPIC) is a cooperative effort of Oregon State University and the US EPA. NPIC provides consultation to poison centers and other health care professionals for the management of pesticide poisoning. Calls regarding emergency cases requiring immediate medical response will be transferred to the Oregon Poison Center.
    1) NPIC contact information: phone: 1-800-858-7378. email: npic@ace.orst.edu Hours: 8 AM to 12 PM Pacific time Monday through Friday, excluding holidays.

Range Of Toxicity

Summary

    A) TOXICITY: Inadvertent ingestions of less than one box of bait rarely cause clinical or laboratory coagulopathy. Patients have survived oral doses of other coumarin derivatives in the 100 to 250 mg range. Patients inadvertently exposed to 1 mg or more of active ingredient long-acting anticoagulant rodenticides (LAARs) should be evaluated for coagulopathy 48 to 72 hours after ingestion.
    B) The World Health Organization (WHO) has classified bromadiolone, technical grade, as pesticide class IA (extremely hazardous).

Minimum Lethal Exposure

    A) PESTICIDE CLASSIFICATION
    1) The World Health Organization (WHO) has classified bromadiolone, technical grade, as pesticide class IA (extremely hazardous) (World Health Organization, 2006).

Maximum Tolerated Exposure

    A) SUMMARY
    1) In a prospective study of 545 children younger than 6 years with unintentional ingestion of less than one box of bait, 463 patients received follow up by phone contact (222), 48 to 96 hour INR (62) or both (179). No child had clinically significant coagulopathy (Ingels et al, 2002).
    a) Two patients had an INR of 1.5 or greater without symptoms, 2 had single nose bleeds with normal INRs, one had blood streaked stool and normal INR.
    2) The overall incidence of abnormal prothrombin times was 7.2% in one study of 110 cases (Smolinske et al, 1989) and 0% in another study of 88 cases (Sullivan et al, 1989). In the latter study, 56% of the patients did not have PTs obtained later than 24 hours postingestion, thus some prolonged PTs may not have been detected. Aggressive decontamination may also have prevented toxicity.
    3) Patients have survived oral doses of other coumarin derivatives in the 100 to 250 mg range (Vogel et al, 1988; Burucoa et al, 1989).
    B) LONG-ACTING ANTICOAGULANT RODENTICIDES
    1) Asymptomatic patients inadvertently exposed to 1 mg or more of active ingredient long-acting anticoagulant rodenticides should be evaluated for coagulopathy 48 to 72 hours after ingestion (Caravati et al, 2007).

Serum Plasma Blood Concentrations

    7.5.2) TOXIC CONCENTRATIONS
    A) TOXIC CONCENTRATION LEVELS
    1) A 27-year-old woman developed easy bruising, epistaxis, menorrhagia and a PT of 35.6 with a serum bromadiolone level of 40 nanograms/milliliter (Chow et al, 1992).
    2) Bromadiolone (concentrations of 0.011 to 0.75 mg/L) was detected in 13 of 16 blood samples obtained from a 62-year-old woman with repeated exposure to bromadiolone. The mean plasma/blood ratio was approximately 1.7 +/- 0.6 (Vindenes et al, 2008).

Workplace Standards

    A) ACGIH TLV Values for CAS28772-56-7 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS28772-56-7 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS28772-56-7 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS28772-56-7 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) References: RTECS, 1999 HSDB, 1999
    1) LD50- (ORAL)MOUSE:
    a) 1750 mcg/kg
    2) LD50- (ORAL)RAT:
    a) 490 mcg/kg
    b) 1.125 mg/kg

Physicochemical

Physical Characteristics

    A) White to off-white odorless powder. Technical grade (97% pure) is a yellowish powder (HSDB , 1999).

Molecular Weight

    A) 527.42 (HSDB , 1999)

References

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