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Monsour Law Firm
404 N Green St
Longview, Texas 75601
PO Box 4209
Longview, TX 75606
903-758-5757
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Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention if you think you have used too much of this medicine. Ketek is not expected to cause overdose symptoms.
Ketek can cause blurred vision, double vision, or trouble focusing. Be careful if you drive or do anything that requires you to be awake and alert.
Telithromycin is an FDA approved antibiotic drug, which belongs to the ketolide class, marketed in the U.S. by Aventis under the brand name Ketek. Telithromycin was approved in the U.S. in April 2004.
Ketek (telithromycin) is indicated for the treatment of very serious bacterial infections, such as community-acquired pneumonia (including multi-drug resistant Streptococcus pneumoniae), acute bacterial sinusitis, and acute exacerbation of chronic bronchitis.
These reports are significant due to the serious nature of the adverse events. All three patients had jaundice and abnormal liver function. One patient recovered, one required a transplant, and one died. All three patients had previously been healthy.
Yes. The FDA’s MedWatch program received reports of the three serious adverse events following administration of telithromycin that were published in the Annals of Internal Medicine.
The FDA has also received other reports of liver-related adverse events in patients taking telithromycin. Some of these reports were difficult to interpret because they involved patients already taking other medicines or patients with other medical conditions that might cause liver problems. In pre-marketing clinical studies, including a large safety trial, the occurrence of liver problems was infrequent and usually reversible.
The Office of Drug Safety looked at adverse events, including hepatic adverse events, in a consult in June 2005 and concluded that there was no new information that changes its assessment of the hepatic risks.
Based on the pre-marketing clinical data it appeared that the risk of liver injury with telithromycin was similar to that of other marketed antibiotics.
Prior to approval, the FDA looked extensively at the potential for hepatic toxicity in patients treated with Ketek. The data examined included a 25,000 patient controlled study, as well as information in nearly 4 million postmarketing prescriptions outside the United States. Ketek was the subject of two advisory committee meetings with input from a national expert on drug-induced liver disease. The committee concluded that the risk for hepatotoxicity from Ketek was similar to Augmentin and erythromycin which are other approved antibiotics.
Patients who have been prescribed telithromycin and are not suffering side effects such as jaundice should continue taking their medicine as prescribed.
Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare providers.
Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems. Telithromycin should be stopped in patients who develop signs or symptoms of liver problems. As with all antibiotics, telithromycin should only be used for infections by a susceptible microorganism; telithromycin is not effective on viral infections, so a patient with a viral infection who took telithromycin would be taking a risk without any benefit.
Telithromycin is marketed and used extensively in many other countries, including Japan and countries in Europe. The FDA is working with regulatory authorities in these other countries to obtain further information on reports of liver problems associated with the use of telithromycin. While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.