Thu 25 Jun 2026
All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.
All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.
2024-02-21
The FDA announced the removal of two indications from the labeling for the antibiotic Ketek (telithromycin), as well as the addition of a black-box warning.
Following the recommendations issued by an advisory panel in December, the FDA removed indications for acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis from Ketek's label. The drug's sole remaining indication is for the treatment of mild to moderate community-acquired pneumonia.
The drug will now carry a black-box warning against its use in patients with myasthenia gravis, and strengthened warnings about visual disturbances, loss of consciousness, and other adverse events, in addition to the warnings about hepatotoxicity strengthened in June.
Source: Food and Drug Administration
Warning date
Last update date: 26/02/2024 at 12:48 AM Saudi Arabia time
No feedback has been submitted for this page yet.
Comments and Suggestions
For any inquiries or comments about the government services, please fill in the required information.