February 12, 2007: FDA Warns on Ketek Use Risks
The antibiotic Ketek should no longer be used for the treatment of sinusitis and bronchitis, the U.S. Food and Drug Administration (FDA) is warning patients and health care providers. The new warnings came as part of an FDA announcement of changes to Ketek's label, including stonger warnings regarding the drug's side effects, and the addition of a "black box" warning stating that Ketek should not be used to treat patients who have myasthenia gravis, a condition that causes muscle weakness. The FDA continues to approve the use of Ketek in treatment of patients with pneumonia. Ketek is manufactured by Sanofi Aventis, and was originally approved by the FDA in 2004. Read the FDA Press Release
June 29, 2006: FDACompletes Safety Assessment of Ketek
The U.S. Food and Drug Administration (FDA) notifiedhealthcare professionals and patients that it has completed its safetyassessment of Ketek, an antibiotic medicine used to treat certain respiratory infectionscaused by bacteria. Ketek has been associated with rare cases of serious liveryinjury and liver failure, including four reported deaths and one livertransplant after the administration of the drug. Although the FDA concludedthat Ketek's benefits outweigh its risks, it has determined that additionalwarnings are required, and advises both patients and healthcare professionals towatch for signs and symptoms associated with liver injury. Click here to readmore from the FDA.
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