Telithromycin, which goes by the brand name of Ketek, is an antibiotic used to treat mild to moderate respiratory infections in the lungs and sinuses. Ketek was developed by French pharmaceutical company Hoechst Marion Roussel in 1998 and approved for use in the United States in April of 2004. The proper dose of Ketek tablets is 2 tablets of 400 mg taken orally once every 24 hours, for 7-10 days.
Ketek Linked to Liver Failure and Other Serious Side Effects
Side effects of Ketek include diarrhea, nausea, abdominal pain, headache, disturbances in taste, and vomiting. Less common side-effects include palpitations, blurred vision, dry mouth, anxiety, and rashes. In women, yeast infections and increased platelet count were common. Another serious side effect caused by Ketek is liver damage, liver disease or liver failure. The FDA's Office of Epidemiology and Surveillance identified 261 cases of acute liver failure, resulting in 25 deaths, and an additional 80 cases of serious liver injury in patients taking Ketek. Symptoms of liver problems include dark urine, itchy skin, and jaundice.
FDA Issues Warning
On January 20, 2006, the FDA released a Public Health Advisory about Ketek, stating that serious liver problems occur with use of Ketek. On February 12, 2007, the FDA issued a black box warning to Ketek, so that doctors will know the drug should not be prescribed to patients who have myasthenia gravis, which is a disease that affects the muscles. The FDA also stated that Ketek is only to be prescribed for community-acquired pneumonia, and that Ketek should no longer be prescribed for acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis, as suggested by an advisory panel due to the serious side effects associated with Ketek.
According to The Wall Street Journal, an Alabama doctor submitted false clinical information to the drug's Phase III study and was convicted of mail fraud after being charged with falsifying clinical data in the drug's comparative study. Aventis failed to disclose the study's known integrity problems when it submitted the drug's clinical trial results to the FDA. In light of the misconduct surrounding Ketek's approval, a Congressional investigation was implemented to discover the FDA's process behind approving the drug.