{"id":1178,"date":"2014-12-19T07:37:45","date_gmt":"2014-12-19T12:37:45","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1178"},"modified":"2014-12-19T12:56:49","modified_gmt":"2014-12-19T17:56:49","slug":"nominating-thiamphenicol-for-idsas-10-x-20-campaign","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/12\/19\/1178\/nominating-thiamphenicol-for-idsas-10-x-20-campaign\/","title":{"rendered":"Nominating Thiamphenicol for IDSA\u2019s 10 x \u201920 Campaign"},"content":{"rendered":"

If you were developing a new antibiotic with a novel MoA, one that covers most GPC, most GNR, most anaerobes and atypicals, including many MDR pathogens like MRSA, enterococci (both E. faecalis and E. faecium), and one that has also activity against\u00a0rickettsiae and bioterrorism agents, you would consider it a sure blockbuster. \u00a0If it\u00a0eventually were shown that this drug can cause aplastic anemia (in 1 of 30,000 cases) it would still be considered a useful antibiotic but relegated to back-up status.<\/p>\n

\"Aplastic<\/a>
Bone marrow in aplastic anemia<\/figcaption><\/figure>\n

This is indeed how chloramphenicol is used abroad. \u00a0Not so in the US where a litigious environment enforces blind adherence to guidelines and labeling orthodoxy. \u00a0A patient dying from a MDR infection or\u00a0ending up on dialysis\u00a0post-colistin therapy is\u00a0easier to defend than a case of aplastic anemia\u00a0due to chloramphenicol requiring BMT.<\/p>\n

Wait, what about serious anaphylactic reactions to\u00a0penicillins?\u00a0 Admittedly rare, they can end deadly [1]<\/a>. \u00a0Between 1 in 2000 to 1 in 10,000 patients exposed to penicillin will have a true Type 1 anaphylactic reaction from which 10% will die.<\/p>\n

Why is dying from anaphylactic shock an acceptable outcome but BMT for\u00a0aplastic anemia is not?\u00a0 Why are we using the beta-lactam class of antibiotics without much concern but treat\u00a0chloramphenicol like a leper?.<\/p>\n

I am not trying to make the case for broader use of chloramphenicol (although one could certainly argue in favor of its revival).\u00a0 \u00a0Instead, I\u2019d like to make a pitch for reintroducing thiamphenicol into clinical practice.\u00a0 Thiamphenicol is almost as active as chloramphenicol, has a similarly broad antibacterial spectrum, and is certainly a lot safer than chloramphenicol.<\/p>\n

The reactive nitroso group released from chloramphenicol is most likely the mutagenic trigger for aplastic anemia.\u00a0 Whether correct or not, pharmaceutical chemists have heeded the warning and come up with thiamphenicol and florfenicol, two very similar drugs which no longer have a NO2 side chain on the molecule [2]<\/a> [3]<\/a> [4]<\/a> [5]<\/a>. Importantly, neither has been associated with aplastic anemia despite significant use in Europe and Asia.\u00a0 So, why are we not introducing thiamphenicol into our antibiotic armamentarium?<\/p>\n

You may think that there is no commercial interest because chloramphenicol and thiamphenicol are cheap old drugs without patent protection.\u00a0 I would say: So what!\u00a0 If after all these years generic amoxicillin can still generate hundreds of million dollars of revenue each year for generics companies like Sandoz, a business case can be made for thiamphenicol too.<\/p>\n

Let\u2019s nominate thiamphenicol for QIDP status and FDA fast-tracking.\u00a0 It has a lot more going for it than most\u00a0drugs currently in Phases 2 and 3 development.\u00a0 Move over, ‘new’ quinolones, aminoglycosides, oxazolidinones and\u00a0tetracyclines – there is an old but better player around.<\/p>\n

\u00a0Abbreviations:<\/strong><\/p>\n

BMT \u00a0 \u00a0 \u00a0 \u00a0 \u00a0bone marrow transplantation
\nQIDP \u00a0 \u00a0 \u00a0 \u00a0qualified Infectious Diseases product
\nMoA \u00a0 \u00a0 \u00a0 \u00a0 \u00a0mechanism of action
\nGPC \u00a0 \u00a0 \u00a0 \u00a0 Gram-positive cocci
\nGNR \u00a0 \u00a0 \u00a0 \u00a0 Gram-negative rods
\nMDR \u00a0 \u00a0 \u00a0 \u00a0 multi-drug resistant
\nMRSA \u00a0 \u00a0 \u00a0 methicillin-resistant S. aureus<\/p>\n

References:\u00a0<\/strong><\/p>\n

[1]<\/a> R. Lin.\u00a0 A perspective on penicillin allergy.\u00a0 Arch Int Med 1992; 152: 930
\n[2]<\/a> Mandell, Chapter 26: M. Moffa: Tetracyclines, Glycylcyclines, and Chloramphenicol.\u00a0 Mandell\u2019s PPID, 8th<\/sup> ed. 2014
\n[3]<\/a>\u00a0ttp:\/\/www.merckmanuals.com\/vet\/pharmacology\/antibacterial_agents\/chloramphenicol_and_congeners.html
\n[4]<\/a> R. Root, ed. Tetracyclines and Chloramphenicol.\u00a0 P. 301 in: Clinical Infectious Diseases \u2013 A Practical Approach, Oxford Univerity Press, 1999
\n[5]<\/a> M. Wilcox.\u00a0 Chapter 16: Chloramphenicol and Thiamphenicol.\u00a0\u00a0 In: R. Finch (ed).\u00a0 Antibiotic and Chemotherapy. \u00a0Elsevier 2010<\/p>\n","protected":false},"excerpt":{"rendered":"

If you were developing a new antibiotic with a novel MoA, one that covers most GPC, most GNR, most anaerobes and atypicals, including many MDR pathogens like MRSA, enterococci (both E. faecalis and E. faecium), and one that has also activity against\u00a0rickettsiae and bioterrorism agents, you would consider it a Continue reading Nominating Thiamphenicol for IDSA\u2019s 10 x \u201920 Campaign<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1181,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[19,18],"tags":[547,176,725,721,719,722,720,264,718,724,224,27,254,723,726,263,716],"class_list":["post-1178","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qidp_antibiotic","category-the_viewpoint","tag-10-by-20","tag-aminoglycoside","tag-amoxicillin","tag-anaphylaxis","tag-aplastic-anemia","tag-beta-lactam","tag-bmt","tag-chloramphenicol","tag-fda-fast-track","tag-florfenicol","tag-fluoroquinolone","tag-idsa","tag-oxazolidinone","tag-penicillin-allergy","tag-sandoz","tag-tetracycline","tag-thiamphenicol"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/12\/Thiamphenicol-slider-copy.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-j0","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":6294,"url":"https:\/\/allphasepharma.com\/dir\/2026\/03\/14\/6294\/where-are-the-chloramphenicol-derivatives\/","url_meta":{"origin":1178,"position":0},"title":"Where 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