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The allergen extract database: assessments

The allergen extract database: assessments. Ronald L. Rabin, MD Chief, Laboratory of Immunobiochemistry Division of Bacterial, Parasitic and Allergenic Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research, USFDA. Background

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The allergen extract database: assessments

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  1. The allergen extract database: assessments Ronald L. Rabin, MD Chief, Laboratory of Immunobiochemistry Division of Bacterial, Parasitic and Allergenic Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research, USFDA

  2. Background Allergenics efficacy reviews Panel 1, 21 CFR 601.25 (1974-1979) Panel 2, 21 CFR 601.26 (1982-1983) Current evaluation process (2003-2011) Safety of allergenic extracts Assessments Next steps Today’s presentations

  3. Panel 1 reviewed 773 extracts Category I: 335 Category II: 1 Category IIIA: 431 Category IIIB: 6 Panel 2 reviewed 752 extracts Category I: 723 Category II: 29 Current review: 1269 extracts Safety review and literature demonstrates that safety concerns are associated with the procedure of immunotherapy rather than any one product or set of products Safety and efficacy of non-standarized allergen extracts

  4. Product Manufacturers of this Product Search Strategy Nomenclature Parent Product Related Product Published Data Reference Document List Original and Reclassification Panel recommendations http://www.fda.gov/BiologicsBloodVaccines/Allergenics/ucm272115.htm Format of database

  5. Format of database: Product Product Name as listed in FDA files Product Category Database entry number

  6. Manufacturers of this Product Antigen Laboratories, Inc. - Liberty, MO (Lic. No. 468, STN No. 102223) Greer Laboratories, Inc. - Lenoir, NC (Lic. No. 308, STN No. 101833) Hollister-Stier Labs, LLC - Spokane, WA (Lic. No. 1272, STN No. 103888) ALK-Abello Inc. - Port Washington, NY (Lic. No. 1256, STN No. 103753) Allermed Laboratories, Inc. - San Diego, CA (Lic. No. 467, STN No. 102211) Nelco Laboratories, Inc. - Deer Park, NY (Lic. No. 459, STN No. 102192) Allergy Laboratories, Inc. - Oklahoma City, OK (Lic. No. 103, STN No. 101376) All manufacturers distribute the extract of this species under the same name; not always the case. Format of database: Manufacturers of this Product

  7. Search Strategy PubMed: "alternaria alternata"; "alternaria tenuis"; "alternaria alternata" allergen; "alternaria tenuis" allergen; "alternaria alternata" immunotherapy Google: alternaria tenuis allergy; alternaria tenuis allergy adverse; alternaria tenuis allergen; alternaria tenuis allergen adverse Note that searches included scientific/medical and lay sources Format of database: Search Strategy

  8. Nomenclature ATCC website: Alternaria alternata (Fries) Keissler, anamorph deposited as Alternaria tenuis Nees, anamorph. Stedmans Book (ATCC Fungus Names, 1993): Alternaria alternata (Fries) Keissler (1912);Synonomy: Alternaria tenuis, Nees 1816; Alternaria tomato (Cooke) Brinkman 1931; Alternaria dioscoreae, Vasant Rao, 1961; Torula alternata Fries 1832. Index Fungorum website: Alternaria alternata (Fr.) Keissl., Beih. bot. Zbl., Abt. 2 29: 434 (1912); Synonymy:Torula alternata Fr., Syst. mycol. (Lundae) 3(2): 500 (1832); Ulocladium consortiale sensu Brook; fide NZfungi (2008); Alternaria tenuis Nees, Syst. Pilze (Würzburg): 72 (1816); Macrosporium asciculatum Cooke & Ellis, Grevillea 6(no. 37): 6 (1877); Alternaria fasciculata (Cooke & Ellis) L.R. Jones & Grout, Bull. Torrey bot. Club 24(5): 257 (1897); Alternaria rugosa McAlpine, Agric. Gaz. N.S.W., Sydney 7:304(1896). Sources: ITIS: Integrated Taxonomic Information System; http://www.itis.gov ATCC: American Type Culture Collection; http://www.atcc.org/ATCCAdvancedCatalogSearch/tabid/112/Default.aspx Database field: Nomenclature

  9. ITIS Database

  10. ITIS search on “ragweed”

  11. ITIS—“short ragweed” 11

  12. ITIS—“short ragweed”

  13. ITIS—“short ragweed” 13

  14. Recommended Scientific Name Alternaria alternata Recommendations based on Nomenclature review Harmonizes nomenclature among products derived from the same species Minimizes prescription errors Format of database: Recommended Names

  15. Parent Product 371 - Molds, Rusts and Smuts, Alternaria tenuis (alternata) Aligns all products (“Parent” with “Related”) derived from the same species into a subset of identical extracts For alternaria alternata, there are no “related products.” Database field: Parent Product

  16. Parent Product 1208 - Pollens - Weeds and Garden Plants, Sage, Mugwort, Western Artemisia ludoviciana Related Products 1146 - Pollens - Weeds and Garden Plants, Mugwort, Darkleaved Artemisia ludoviciana 1147 - Pollens - Weeds and Garden Plants, Mugwort, Western Artemisia ludoviciana 1204 - Pollens - Weeds and Garden Plants, Sage, Mixed Artemisia ludoviciana 1212 - Pollens - Weeds and Garden Plants, Sage, Prairie, Artemisia gnaphaloides 1213 - Pollens - Weeds and Garden Plants, Sage, Western Artemisia gnapholodes 1224 - Pollens - Weeds and Garden Plants, Sagebrush, Prairie Artemisia gnaphalodes 1225 - Pollens - Weeds and Garden Plants, Sagebrush, Prairie Artemisia ludoviciana 1229 - Pollens - Weeds and Garden Plants, Sagebrush, Western Artemisia graphaloides 1230 - Pollens - Weeds and Garden Plants, Sagebrush, White (Prairie) Artemisia ludoviciana This is an example of products that are “Related” to a “Parent” product Database field: Related Product (Mugwort)

  17. Published Data A. alternata (and Cladosporium) sensitivity correlates with asthma severity in Europe. A. alternata was used for diagnosis in several papers, PMID 8842553, 1987459, 10843433, 10200024, 15940136, 15614195, 3993865. Several trials demonstrate that immunotherapy works in rhinitis, PMID 10843433, 12906784, 15745389, 15736717, 3993865, 2406323, 3381709. Note severe reactions reported in PMID 3544937. Publications usually listed by PubMed ID (PMID) for ease of search and download Brief summary of the report(s) Database field:Published Data 17

  18. Format of database: Documents Document: Abbreviated citation PubMed identification number (PMID) First Author Year of publication

  19. Table 1. Use in Diagnosis and Treatment Addressed in Literature (480) Table 2. Foods: Use in Diagnosis Addressed in Literature (134) Table 3. Non-food: Use in Diagnosis Addressed in Literature (73) Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566) Table 5. Potential Safety Issues (16) Internal review determinations(1269 products reviewed)

  20. Product: 762 - Pollens - Trees, Box Elder Acer negundo Manufacturers of this Product Antigen Laboratories, Inc. - Liberty, MO (Lic. No. 468, STN No. 102223) Greer Laboratories, Inc. - Lenoir, NC (Lic. No. 308, STN No. 101833) Hollister-Stier Labs, LLC - Spokane, WA (Lic. No. 1272, STN No. 103888) ALK-Abello Inc. - Port Washington, NY (Lic. No. 1256, STN No. 103753) Allermed Laboratories, Inc. - San Diego, CA (Lic. No. 467, STN No. 102211) Nelco Laboratories, Inc. - Deer Park, NY (Lic. No. 459, STN No. 102192) Allergy Laboratories, Inc. - Oklahoma City, OK (Lic. No. 103, STN No. 101376) Table 1. Use in Diagnosis and Treatment Addressed in Literature

  21. Search Strategy PubMed: Acer negundo allergens; Boxelder allergens Google: box elder allergy; box elder allergy adverse; box elder allergen; box elder allergen adverse; same search results performed for Acer negundo Table 1. Use in Diagnosis and Treatment Addressed in Literature

  22. Nomenclature According to ITIS, the scientific name, Acer negundo, is correct and current. Common names are ashleaf maple, box elder, boxelder maple, California boxelder, . . . The Acer genus is found in the Aceraceae family. PLANTS database states that Acer negundo is in the Aceraceae Family or Maple Family and lists five varieties of A. negundo that have the common name, . . . Table 1. Use in Diagnosis and Treatment Addressed in Literature

  23. Published Data Panel 1 (pg 3157) cites two case studies of skin test diagnosis for maple pollen extracts (Ref. 153 and 154) but did not specify their genus or species. PMID 12221895 describes how patterns of cross-sensitivity to tree pollens were identified. . . The following tree pollens were examined by modified radioallergosorbent test (RAST): oak, birch, beech, poplar (populus deltoides), . . The highest prevalence of hypersensitivity was for (birch, oak, and maple). . . PMID 3944375 reports on the use of polymerized ragweed (PRW), polymerized grasses (IPG) and polymerized trees (IPT) for immunotherapy in ragweed patients. . . All patients had (+ SPT to one or) more of the following 1:10 tree extracts: white oak, elm, or box elder. . . The patient's immunotherapy was administered in 12 weekly visits during the spring and summer of 1983. Of the 16 recruited patients, 10 were prick positive to box elder, 13 to elm, and 14 to oak. . . In terms of Safety, . . there were no systemic reactions in this group of patients. . . Table 1. Use in Diagnosis and Treatment Addressed in Literature

  24. Format of database: Previous Panel Category Determinations

  25. Product: 557 - Plants and Plant Parts, Jute Corchorus sp. PubMed: jute; jute allergy; jute allergen; jute immunotherapy; jute corchorus Google: jute corchorus allergy; jute corchorus allergy adverse; jute corchorus allergen; jute corchorus allergen adverse Recommended Scientific NameCorchorus, (species to be specified) Manufacturers of this Product (Refer to published database) Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment

  26. Search Strategy PubMed: jute; jute allergy; jute allergen; jute immunotherapy; jute corchorus Google: jute corchorus allergy; jute corchorus allergy adverse; jute corchorus allergen; jute corchorus allergen Nomenclature According to the USDA PLANTS database, there are 9 species of Corchorus. According to ITIS, there is one variety and eight species of Corchorus. The Corchorus genus is found in the Tiliaceae family. Parent Product 557 - Plants and Plant Parts, Jute Corchorus sp. Published Data No supportive data were identified. Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment

  27. Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment

  28. Table 1. Use in Diagnosis and Treatment Addressed in Literature (480) Table 2. Foods: Use in Diagnosis Addressed in Literature (134) Table 3. Non-food: Use in Diagnosis Addressed in Literature (73) Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566) Table 5. Potential Safety Issues (16) Internal review determinations(1269 products reviewed)

  29. Internal review compared to Panel 1 and 2 Internal evaluations of Panel 1 products Panel 1 category Diagnosis and treatment addressed in the literature (Percent) Internal evaluations of Panel 2 products Panel 2 category

  30. The current internal panel reviewed 1269 non-standardized allergenic products. Each was placed into one of five categories: Table 1. Use in Diagnosis and Treatment Addressed in Literature (480) Table 2. Foods: Use in Diagnosis Addressed in Literature (134) Table 3. Non-food: Use in Diagnosis Addressed in Literature (73) Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566) Table 5. Potential Safety Issues (16) Summary

  31. Background Allergenics efficacy reviews Panel 1, 21 CFR 601.25 (1974-1979) Panel 2, 21 CFR 601.26 (1982-1983) Current evaluation process (2003-2011) Safety of allergenic extracts Assessments Next steps Today’s presentations

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