One of the major changes will be that two of the three previously approved usages of the Ketek will no longer apply. Ketek will no longer be prescribed for acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. These indications (or treatment for these illnesses) will be removed from the drug labels.
According to the FDA, the benefit-risk ratio no longer supports the medical use of prescribing Ketek for these conditions.
Steven Galson, MD, the director for the Center for Drug Evaluation and Research, said, "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 healthcare providers the most up-to-date prescribing information."
These final decisions were based on the results of the mid-December meetings between the experts for drug safety, the drug advisory committee, the FDA, and the manufacturer.
Sanoti-Adventis has further agreed to update the Ketek product labels with an additional "boxed warning," which is the FDA's strongest form of warning. This warning will provide information that states Ketek is contraindicated, that is, it should not be used, in patients who have myasthenia gravis disease.
The manufacturer has also worked with the FDA in updating the patient information sheets to be provided to all patients who receive this prescription medication.
In addition, more definitive label changes will also provide patients with further warnings for the drug.
