FDA panel barely approves new antibiotic for pneumonia

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Friday, the FDA’s Antimicrobial Drug Advisory Committee split 7 to 6, to approve Solithromycin, a new drug for community-acquired pneumonia. Pneumonia is responsible for 4.5 million ambulatory visits. About half of bacteria causing pneumonia in the US are now resistant to the best current treatment option. The committee agreed that the drug was proven effective, but serious concerns were raised about liver toxicity.  The concerns centered on small sample sizes of clinical trials, troubling liver enzyme levels in patients, and a scandal from a decade ago when a similar drug was approved, but was later linked to deaths from liver failure. The problem is identifying somewhat rare but deadly adverse events in clinical trials which cannot include enough patients to detect the problem directly. In the end, most members felt that as bacterial resistance to antibiotics is rising quickly, we don’t have time to wait for perfect data.