Volume 3
Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.
- United States. Congress. Senate. Committee on Government Operations
- Date:
- 1963
Licence: Public Domain Mark
Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.
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![ance studies using the drug in dogs. It was noted that similar allergic mani- festations had been observed in dogs by previous workers following administra- tion of Tween 20, but it was ‘‘demonstrated that the allergic response to Tween administration occurs only in the canine species.” (This limitation was based upon data from a series of four hospitalized patients!) The manufacturer’s report concluded that ‘‘* * * results obtained in both animal and clinical studies indicate that a formulation containing 2 percent (and 4 percent) Tween 80 would be suitable for clinical use’’. Supplemental reports of clinical investigators forwarded by the manufacturer on January 6, 1959, included a total series of 104 patients who had received the drug. One investigator within this total group noted side reactions in 2 of 20 patients. These reactions consisted of “dyspnea, severe backache” in one patient and ‘shortness of breath, visual disturbance” in the other. ALBERT F. Esco, M.D. = (C20 Pay = BUDGET BUREAU NO. $7-R004.4 2 REPORT OF ADVERSE REACTION TO DRUG APPROVAL EXPIRES 12-31-63 2 cee i. Case Ne. ‘12. Neme or isitials 4. Sex Color Age | $. Oceupatioa Ss 9 7-62-2 S.S. Bewhas &. Admission Date | 7. Disckarge Date § July 62 7 2 — “a3 ae tenor: — : ee oer: LRG EEE 9. Particular. ingrediest(e) ia drug prepazatica respoasible 20. Deug reaction 2 for reactios (ase generic ce official name) |! Anaphylactoid Reaction = : : | (Air Hunger, back pain, cyanosis cy we = Pha act generalized petechial reaction) 4 10. Trade name of drug preperation KONAK ION | 21. Laberesecy fiediage relating co reaction, if pestiaent _ 11. Quantitative Composition (generic or official name of { each ingrediase) is drag prepasation - 2-methyl-3 phytyl 1, & naph- thoquinone | 22.'\Treatme me of reaction 12. Dosage form j IV 15 mg | 0.3 ce aq epinephrene 8Q 13. Manufecturer’s same and address Roche Laboratories Nutely, N.J. | 23. Outcome: Seill wader 14. Mir. Lot 15. Ie semainiag portioa of ] observariea.____._- ve quelae —__iajury. Code No.012-071 713 deug available? Yes Nature 16. Condition for which suspected drug was administered Low prothrombin time ; Date of death______Autopsy. | 24. If reaction occurred peice to hospitalination, was drug taken uader: Direction of physicias? [_] selfmsdiestice? (_) No follow-up 17. Ocher pertinent medical coaditions Systemic Lymphoma (petryjo Jo SusaT3Q) (8)3g2:par3u] ajqusucdsay 25. Factors ceatriburiag to reaction, e.g., drug aduleerated, mislabeled, etc. (see Guide) Drug administered over 1 minute ie in excess of 5 mg/min. 18. Dosage schedule: a. Amount, rowe aad frequency of ladividuai dose 15 mg IV GNOTAVNOLAHd 2UN 2P¥3y pos b. Toral sumber of doses ce. Teral amount given ORT] S1Y) PAuqw 33138 JON oq -£1u0 asn vad 24 (4% NIRVIIA) 1 15mg | 26. History of peovious expoeuce to ouspected apent(s) d. Date of fiese dose e. Date of easet of reaction 23 July 62 23 July 62 rimese f. Interval berweea last dose and oaset of reaction 30 - 60 seconds 27, Evaluatioa of case. Include mechanism of ceaction (e.g., overdosage, allergy, \etc.) (eee Guide) 19. Coacuerent drug therapy (including desage schedule) Phenobarbital 30 mg qid (0) | Probable idiosyncracy](https://iiif.wellcomecollection.org/image/b32183148_0003_0349.jp2/full/800%2C/0/default.jpg)
