Update on FARAD food animal drug withholding recommendations

Haskell, Scott R. R.; Gehring, Ronette; Payne, Michael A.; Craigmill, Arthur L.; Webb, Alistair I.; Baynes, Ronald E.; Riviere, Jim E.

doi:10.2460/javma.2003.223.1277

Cited by 24 publications

(11 citation statements)

References 5 publications

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“…Several papers have described tetracycline-class depletion from milk, but only 4 have reported results with similar levels of sensitivity to ours (Anderson et al, 1995;Dinsmore et al, 1996;Martin-Jimenez et al, 1997;Haskell et al, 2003). Of those, Anderson et al (1995) used clinically normal postpartum cows; Dinsmore et al (1996) used cows with retained placentas and monitored the severity of disease based on rectal temperature.…”

Section: Figurementioning

confidence: 71%

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A study to examine the relationship between metritis severity and depletion of oxytetracycline in plasma and milk after intrauterine infusion

Gorden

Ydstie

Kleinhenz

et al. 2016

Journal of Dairy Science

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Metritis is a frequent problem in postpartum dairy cows. Intrauterine therapy with the antimicrobial oxytetracycline (OTC) is often used, although this therapy has not been shown to be superior to systemic therapy. The objectives of this study were to (1) determine the plasma and milk concentrations of OTC following intrauterine infusion in postpartum dairy cows with varying degrees of metritis severity; (2) determine the depletion time of OTC in an attempt to provide veterinarians withdrawal guidelines, should they use this therapy; and (3) correlate metritis severity scores with OTC concentrations in plasma and milk. Our hypothesis was that cows with more severe metritis would have higher OTC concentrations in milk following intrauterine therapy. Thirty-two cows were selected to participate in the study after farm personnel had determined that they had metritis based on evaluation of vaginal discharge between 4 and 14 DIM, in accordance with the farm's treatment protocols. Metritis scores (1-4) were assigned based on a published scheme: 1 represented yellow-to-orange thick discharge or translucent mucus with no fetid smell; 2 represented blood-tinged vaginal mucus, slightly watery, with little or no fetid smell; 3 represented red to red/brown watery discharge with moderate fetid smell; and 4 represented red to red/brown watery discharge containing pieces of placenta and an intense fetid smell. Trial cows received a single treatment of 4g of OTC (approximately 6.7mg/kg) via intrauterine infusion. Blood samples were collected over 96h, and milk samples were collected before intrauterine therapy and 3 times a day for 4 d following infusion. Following treatment, OTC rapidly diffused to plasma and subsequently to milk. Maximum OTC concentrations in plasma and milk occurred within the first 24h following intrauterine infusion, and 25 of the 32 cows had detectable OTC concentrations in milk at 4 d after intrauterine infusion. Cows with clinical metritis (metritis severity scores of 3 or 4) at the initiation of treatment were significantly and positively correlated with higher milk OTC concentrations at the second [time (T)9 h; r=0.43], fourth (T25 h; r=0.42), and fifth milking following treatment (T33 h; r=0.38) compared with cows with normal vaginal discharge. We also observed a positive correlation between initial metritis score and milk maximum concentration (r=0.36) and milk area under the concentration curve (r=0.36). Given that intrauterine administration of OTC is an extra-label therapy, dairy producers should consult with their veterinarian to ensure that milk is being tested at or below the established tolerance for OTC. This will ensure that violative drug residues do not enter the human food supply.

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Section: Figurementioning

confidence: 71%

“…In a Food Animal Residue Avoidance Databank (FARAD) Digest article, Haskell et al (2003) recommended a milk withdrawal time of 72 h following intrauterine infusion of up to 2 g of OTC. Additionally, FARAD's online Withdrawal Interval Recommendations indicate that milk should be withheld for 196 h after intrauterine infusion of 4 to 6 g of OTC.…”

Section: Figurementioning

confidence: 99%

A study to examine the relationship between metritis severity and depletion of oxytetracycline in plasma and milk after intrauterine infusion

Gorden

Ydstie

Kleinhenz

et al. 2016

Journal of Dairy Science

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“…[28][29][30][31][32][33] One online resource, the Food Animal Residue Avoidance Databank, 30 provides residue information for food animals, primarily terrestrial species. [34][35] Compared with what is available for mammals, there is a general lack of the literature describing drug depletion or pharmacokinetic studies in fish. There are also a few fish species, such as channel catfish and salmonids, which dominate the literature.…”

Section: E289mentioning

confidence: 99%

Fish drug analysis—Phish-pharm: A searchable database of pharmacokinetics data in fish

Reimschuessel

Stewart

Squibb

et al. 2005

AAPS J

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Information about drug residues and pharmacokinetic parameters in aquatic species is relatively sparse. In addition, it is difficult to rapidly compare data between studies due to differences in experimental conditions, such as water temperatures and salinity. To facilitate the study of aquatic species drug metabolism, we constructed a Fish Drug/Chemical Analysis Phish-Pharm (FDA-PP) database. This database consists of more than 400 articles that include data from 90 species (64 genera) of fish. Data fields include genus, species, water temperatures, the average animal weight, sample types analyzed, drug (or chemical) name, dosage, route of administration, metabolites identified, method of analysis, protein binding, clearance, volume of distribution in a central compartment (Vc) or volume of distribution at steady-state (Vd), and drug half-lives (t ½ ). Additional fields list the citation, authors, title, and Internet links. The document will be periodically updated, and users are invited to submit additional data. Updates will be announced in future issues of The AAPS Journal. This database will be a valuable resource to investigators of drug metabolism in aquatic species as well as government and private organizations involved in the drug approval process for aquatic species.KEYWORDS: aquatic, fish, drug, pharmacokinetics, residues, database, Web. INTRODUCTIONThere are currently very few drugs approved by the US Food and Drug Administration (FDA) for use in fish. [1][2][3][4] Although there are several reasons for this shortage, the primary factor is a lack of pharmaceutical sponsors willing to invest in the research needed to generate the data to support a drug approval. Such data include demonstration of drug efficacy and safety in the target species, human food safety, and environmental impact assessments. 5 The overall cost of obtaining the experimental data required for a New Animal Drug Application (NADA) can be in excess of $40 million. [6][7][8] Efforts to increase the availability of therapeutic agents for fish and for other minor species include work being done by the National Research Support Project No. 7 6 and the Proposals to Increase the Availability of Approved Animal Drugs forMinor Species and Minor Uses. 9 One strategy being explored for aquaculture drug products is to group species according to those species of fish likely to present with similar safety profiles, effectiveness characteristics, or withdrawal times. [10][11][12][13][14][15][16] Several approaches have been suggested for this "crop grouping," and the proposed basis for grouping species has included taxonomic class, salinity tolerance, or water temperature.The underlying theory for a taxonomic grouping is that organisms closely related phylogenetically might be expected to have similar drug metabolism and elimination. This is definitely the case in fish lacking certain renal elements such as glomeruli and distal tubules. 17 Drugs that are normally filtered by the glomerulus are retained much longer in these fish species....

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“…Azaperone, a neuroleptic in the butyrophenone class of tranquilizers, is metabolized by the liver and rapidly eliminated (Booth 1982;Crowell-Davis and Murray 2006). Azaperone was not detected in pigs even when euthanized at 6 h postinjection (PI; Mestorino et al 2013) and the Food Animal Residue Avoidance Databank recommends 8 d PI for a withdrawal time (Haskell et al 2003). Tissue residues for components of a similar immobilization combination (butorphanol, azaperone, and medetomidine) and the antagonists atipamezole and naltrexone were not detected 11 or 21 d PI in white-tailed deer (O. virginianus;Cook et al 2016).…”

mentioning

confidence: 99%

“…Immobilization with NalMed-A is antagonized with a combination of naltrexone, an opioid antagonist, and atipamezole, a highly selective alpha-2 antagonist, with or without the addition of tolazoline (Wolfe et al 2014). Tolazoline is an alphaadrenergic antagonist and is approved for use in cattle in New Zealand with a recommended withdrawal of 8 d (Haskell et al 2003).…”

mentioning

confidence: 99%

Tissue Residue Levels after Immobilization of Rocky Mountain Elk (Cervus elaphus nelsoni) using a Combination of Nalbuphine, Medetomidine, and Azaperone Antagonized with Naltrexone, Atipamezole, and Tolazoline

Wolfe

Nol

McCollum

et al. 2018

Journal of Wildlife Diseases

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Previous studies demonstrated that nalbuphine, medetomidine, and azaperone (NalMed-A) can effectively immobilize adult elk ( Cervus elaphus nelsoni), and be antagonized using naltrexone and atipamezole, with or without tolazoline. To assess duration of tissue residues for this immobilization package, we immobilized 14 captive adult elk with NalMed-A, then euthanized animals and collected tissues 0, 3, 6, 14, 21, or 28 d later. Except for two animals euthanized immediately, all elk were recovered using naltrexone, atipamezole, and tolazoline. Tissue residues (≥0.01 parts per million) for the tranquilizers nalbuphine, medetomidine, and azaperone were detected in liver and muscle tissue samples from elk euthanized within 40 min postinjection (PI) and one animal that died 12-24 h PI, but not in tissues from any of the animals euthanized at 3, 6, 14, 21, or 28 d PI. Tissue residues for the antagonists naltrexone, atipamezole, and tolazoline were detected in liver and muscle of the animal that died 12-24 h PI. Only naltrexone was detected in liver from the two elk euthanized at day 3, and no antagonist residues were detected thereafter.

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Update on FARAD food animal drug withholding recommendations

Cited by 24 publications

References 5 publications

A study to examine the relationship between metritis severity and depletion of oxytetracycline in plasma and milk after intrauterine infusion

A study to examine the relationship between metritis severity and depletion of oxytetracycline in plasma and milk after intrauterine infusion

Fish drug analysis—Phish-pharm: A searchable database of pharmacokinetics data in fish

Tissue Residue Levels after Immobilization of Rocky Mountain Elk (Cervus elaphus nelsoni) using a Combination of Nalbuphine, Medetomidine, and Azaperone Antagonized with Naltrexone, Atipamezole, and Tolazoline

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