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FDA highlights liver safety issues in Cempra drug review
Published November 03, 2016
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. (REUTERS/Jason Reed/File Photo)
Cempra Inc's experimental drug to treat community acquired pneumonia, the kind suffered by presidential candidate Hillary Clinton recently, causes a potentially concerning rise in liver enzymes, according to a preliminary review by the U.S. Food and Drug Administration.
The review, posted on the FDA's website on Wednesday, comes two days ahead of a meeting of outside experts who will discuss the drug, solithromycin, and recommend whether or not it should be approved. The FDA is not obliged to follow its advisory panel's advice but typically does so.
"A significant safety signal for hepatotoxicity was observed in the solithromycin development program," agency reviewers noted. They said "the high rate of infusion site-related reactions" was another safety concern.
https://www.foxnews.com/health/fda-highlights-liver-safety-issues-in-cempra-drug-review