The New York Times reports that the Food and Drug Administration (F.D.A.) issued a strong warning Thursday that Ketek, a controversial antibiotic, could in rare circumstances cause serious liver injury, liver failure and even death.
Ketek is manufactured by Sanofi-Aventis, the French drug giant, and it has been approved to treat bronchitis, sinusitis and mild-to-moderate pneumonia.
Thursday’s announcement was the culmination of months of internal debate in the drug agency about how to address Ketek’s risks, according to internal agency memorandums obtained by The New York Times. In addition to liver problems, Ketek can cause blurred vision and loss of consciousness. In patients with myasthenia gravis, a rare neurological disorder, it can cause death.
Fourteen adult patients in the United States have suffered liver failure after taking Ketek. At least four of them have died; 23 others suffered serious liver injury.