The Food and Drug Administration on Monday announced labeling changes for the antibiotic Ketek, stripping it of two previously approved indications and adding a black-box warning, the agency’s strongest. The agency removed from the label the drug’s approval for use in the treatment of acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis.
“The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications,” the agency said in a news release.
With Monday’s announcement, Ketek remains approved for just one indication: the treatment of mild to moderate cases of pneumonia acquired outside hospitals or long-term care facilities.
The boxed warning says the drug should not be used in patients with myasthenia gravis, which causes muscle weakness.
“Today’s action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give health-care providers the most up-to-date prescribing information,” said Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research.
References on the label to visual disturbances and loss of consciousness associated with the drug use are also beefed up.
Warnings about toxicity to the liver were made stronger last June.
Ketek was originally approved in 2004 and is manufactured by Paris-based Sanofi Aventis.
The announcement comes a day before the House Subcommittee on Oversight and Investigations is to hold a hearing about the FDA’s drug-review policies.
Witnesses are to include Sen. Chuck Grassley, R-Iowa, an agency critic, and former FDA employees who have criticized the agency’s drug review policies.
Grassley has accused the FDA of withholding evidence about the drug from an advisory committee charged with reviewing it.
Critics have said the agency’s reviewers have been discouraged from raising questions about the agency’s review process, a charge the agency has denied.