OVERVIEW

PRODUCT INFORMATION

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NO	MOLECULAR FORMULA	STRUCTURE
Sarecycline	1035654-66-0	C24-H29-N3-O

ANNOTATED BIBLIOGRAPHY

References updated: 10 April 2019

• Zimmerman HJ. Tetracyclines. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999. p. 599-602.

  (Expert review of tetracycline and liver injury published in 1999; the tetracyclines cause two forms of drug induced liver injury, microvesicular fat and liver failure occurring after 4-10 days with high doses of parenteral tetracyclines and an idiosyncratic liver injury that occurs with the oral agents, doxycycline causing a cholestatic and minocycline a hepatocellular injury which may be associated with autoimmune features).
• Moseley RH. Tetracyclines. Hepatotoxicity of antimicrobials and antifungal agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, p. 468.

  (Expert review of tetracycline induced liver injury; mentions that the hepatotoxicity of intravenous tetracycline is of historic interest only as it is no longer given parenterally; both doxycycline and minocycline have been associated with idiosyncratic liver injury).
• MacDougall C. Protein synthesis inhibitors and miscellaneous antibacterial agents. In, Brunton LL, Hilal-Dandan R, Knollman KC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1049-65.

  (Textbook of pharmacology and therapeutics).
• https://www​.accessdata​.fda.gov/scripts/cder/daf/

  (FDA Drug Approvals website that has product labels [package inserts], letters of approval and full FDA scientific review of the new drug application for safety and efficacy; mentions that pooled safety data indicated that serious adverse events were rare [<1%] and no more common with sarecycline [n=1820] than placebo [n=1113] treatment as were discontinuations for adverse events [1.3% vs 1.3%] and “there were no adverse effects with kidney or liver dysfunction” although 5 subjects discontinued sarecycline therapy because of liver enzyme elevations [one scored as “serious”], all of which were asymptomatic and resolved with stopping).
• Moore A, Green LJ, Bruce S, Sadick N, Tschen E, Werschler P, Cook-Bolden FE, et al. Once-daily oral sarecycline 1.5 mg/kg/day is effective for moderate to severe acne vulgaris: results from two identically designed, phase 3, randomized, double-blind clinical trials. J Drugs Dermatol 2018; 17: 987-96. [PubMed: 30235387]

  (Among 968 patients, ages 9 to 45 years, with facial acne treated with sarecycline or placebo for 12 weeks in 2 randomized controlled trials, inflammatory lesions improved more with sarecycline while adverse events included nausea [5%] and vomiting [2%] and more rarely dizziness and phototoxicity [<1%]; there were “no clinically meaningful differences … in clinical laboratory” measurements in either study).
• Leyden JJ, Sniukiene V, Berk DR, Kaoukhov A. Efficacy and safety of sarecycline, a novel, once-daily, narrow spectrum antibiotic for the treatment of moderate to severe facial acne vulgaris: results of a phase 2, dose-ranging study. J Drugs Dermatol 2018; 17: 333-8. [PubMed: 29537451]

  (Among 285 patients, ages 12 to 45 years, with severe facial acne vulgaris treated with 3 doses of sarecycline or placebo once daily for 12 weeks, inflammatory lesions were improved with higher doses of sarecycline vs placebo while adverse event rates were comparable and there were no serious adverse events; no mention of ALT elevations or hepatotoxicity).
• Deeks ED. Sarecycline: first global approval. Drugs. 2019; 79: 325-9. [PMC free article: PMC6505496] [PubMed: 30659422]

  (Review of the mechanism of action, pharmacology, clinical efficacy and safety of sarecycline from clinical trials on which its FDA approval was based; mentions that adverse events were uncommon but included nausea, vomiting, abdominal pain, sunburn, vulvovaginal candidiasis and mycotic infections; no mention of ALT elevations or hepatotoxicity).