The antibiotic Ketek, manufactured by Sanofi-Aventis, will receive the government's strongest cautionary label on its package. Side effects such as severe liver failure and serious risk to patients with the neuromuscular disease myasthenia gravis have been linked to the drug.
In December 2006, an FDA advisory committee suggested that Ketek have a "black box" warning. The drug's dangerous side effects are considered to outweigh the benefits in combating common infections.
In adopting the black box label, the FDA and Sanofi-Adventis agree that Ketek may no longer be marketed for milder infections, such as sinusitis or bronchitis. However, the medication will continued to be used in treating pneumonia.