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.
