On Monday, February 12, 2007, the U.S. Food and Drug Administration (FDA) announced changes to the labeling and usage of the antibiotic telithromycin (Ketek) to improve its safety for consumers. The FDA is removing two previously approved uses for the drug (treating sinusitis and bronchitis). The agency is adding its strongest warning, the "black-box warning," stating that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness. The manufacturer of Ketek, Sanofi-Aventis, also must work with the FDA to develop a Patient Medication Guide that informs consumers about the risk of the drug and how to use it safely.FDA announces label changes for telithromycin (Ketek)
From Mary Kugler, R.N., About.com GuideFebruary 15, 2007
On Monday, February 12, 2007, the U.S. Food and Drug Administration (FDA) announced changes to the labeling and usage of the antibiotic telithromycin (Ketek) to improve its safety for consumers. The FDA is removing two previously approved uses for the drug (treating sinusitis and bronchitis). The agency is adding its strongest warning, the "black-box warning," stating that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness. The manufacturer of Ketek, Sanofi-Aventis, also must work with the FDA to develop a Patient Medication Guide that informs consumers about the risk of the drug and how to use it safely.Explore Rare Diseases
This is nice to no since i was prescribed this today 2/15/07 for sinusitis!!!!!