February 12, 2007: FDA Warns on Ketek Use Risks
Ketek, an antibiotic for the treatment of sinusitis and bronchitis, should no longer be used according to the US Food and Drug Administration through its warning given to the medical community, healthcare providers, and patients. The warning was given as part of the FDA announcement of the changes to the labels of Ketek, including its warning about the side effects, and the inclusion of a “black box” warning informing that Ketek should not be used to treat patients who have myasthenia gravis, a condition that results to muscle weakness. FDA approves the use of Ketek for the treatment of pneumonia in patients. Ketek is manufactured by Sanofi-Aventis, and received its first approval from the US FDA in 2004.
June 29,2006: FDA Completes Safety Assessment of Ketek
The US Food and Drug Administration has notified the healthcare providers and patients that it has finished its safety evaluation of Ketek, an antibiotic medicine to treat particular respiratory infections caused by bacteria. Ketek was associated with uncommon cases of severe liver injury and liver failure with four reported death and one liver transplant after the administration of the medicine. Even though FDA claimed that the benefits of Ketek outweighed its risks, additional warnings are needed and gave advice to healthcare providers and patients to watch for the symptoms associated with liver injury.