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# Reviewers Raise Liver Safety in Cempra Drug
- URL: https://www.fdaweb.com/reviewers-raise-liver-safety-in-cempra-drug/
- Published: 2016-11-02T12:00:00.000Z
- Updated: 2026-09-14T21:44:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137236

FDA medical reviewers are expressing concern about hepatotoxicity in Cempra’s solithromycin, which goes before the agency’s Antimicrobial Drugs Advisory Committee 11/4 seeking support for an indication to treat community acquired bacterial pneumonia (CABP). A [briefing paper](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM527690.pdf?ref=fdaweb.com) released in advance of the meeting says the rates of transaminase elevations were higher in solithromycin-treated patients than those treated with moxifloxacin and were related to solithromycin exposure. A high rate of infusion site-related reactions associated with solithromycin (31.3%) as compared to moxifloxacin (5.2%) is cited as another concern.

The paper says that rates of deaths and serious adverse events observed in the solithromycin and moxifloxacin arms of the trial were similar.

Solithromycin is described as a semi-synthetic antibacterial drug of the macrolide class/ketolide subclass developed by Cempra Pharmaceuticals for treating CABP caused by *Streptococcus pneumoniae*, *Haemophilus influenza*, *Moraxella catarrhalis*, methicillin-susceptible *Staphulococcus aureus*, *Legionella pneumophila*, and *Mycoplasma pneumoniae*.

The advisory committee is asked to discuss whether Cempra provided substantial evidence of the drug’s efficacy for the proposed indication, whether the risk of hepatotoxicity has been adequately characterized, and whether solithromycin’s risks outweigh the potential benefits in treating CABP.