Questions and Answers on Ketek (telithromycin) February 12, 2007
1. What is Ketek (telithromycin)?
Ketek (telithromycin) is an FDA approved antibiotic drug, which belongs to the ketolide class, marketed in the U.S. by sanofi-aventis under the brand name Ketek. Ketek (telithromycin) was approved in the U.S. in April 2004.
2. What is Ketek (telithromycin) used to treat?
Ketek (telithromycin) is used to treat adults 18 years of age and older with a lung infection called “community acquired pneumonia (of mild to moderate severity)” that is caused by certain bacteria germs.
3. What actions were taken by FDA on February 12, 2007?
FDA approved new labeling with a Medication Guide for patients. The new labeling removes the indications of acute bacterial sinusitis and acute exacerbation of chronic bronchitis; adds a boxed warning and contraindication that state that Ketek is contraindicated (should not be used) in patients with myasthenia gravis; strengthens warnings about visual adverse effects and loss of consciousness; and provides a Medication Guide so that patients can be better informed about the risks associated with use of telithromycin. These changes are in addition to the bolded warning on liver toxicity added to the label in June 2006.
4. Why did FDA take this action?
FDA determined that these updates to the labeling were necessary based on the Agency’s review of all available data for telithromycin. These changes to the label are consistent with the advice given to the agency in a joint meeting of the Anti-Infective Drugs and Drug Safety and Risk Management Advisory Committees in December of 2006. The agency has determined that the balance of benefits and risks supports continued marketing of telithromycin for the treatment of community-acquired pneumonia (of mild to moderate severity).
5. What should patients do regarding this new information?
- Patients should read the new Medication Guide.
- Patients with myasthenia gravis should not take Ketek (telithromycin).
- Patients who have been prescribed telithromycin and are not suffering side effects should continue taking their medicine as prescribed.
- Patients who notice any yellowing of their eyes or skin or have other problems like blurry vision or fainting should contact their healthcare providers.
6. What should healthcare providers do in response to this new information?
Healthcare providers should review the updated labeling. They should note that telithromcyin is only approved for use in the treatment of community-acquired pneumonia, and is contraindicated in patients with myasthenia gravis. Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems. As with all antibiotics, telithromycin should only be used to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Telithromycin is not an effective treatment for viral infections. Therefore, a patient with a viral infection who took telithromycin would have no benefit from that treatment and would have a chance of experiencing harmful side effects from the drug.
7. How does FDA monitor the safety profile of a drug after it is approved?
FDA continually gathers and learns more about a product’s benefits and risks even after it is on the market. Benefits and risks depend on many different factors and can be different in different people. Some of the factors that the FDA, doctors and patients consider, include:
- the severity of the disease being treated, in general and the individual patient’s case
- the outcome of the disease if it is not treated
- the likelihood and degree of benefit from the drug
- other treatment options, if any, and their risks and benefits
- how easy it may be for patients to use the drug according to directions
- the concerns of each individual patient (some patients might find a particular risk or side effect to be not very bothersome while others might suffer greatly from the same side effect)
Thus, assessment and comparison of a product’s benefits and risks is a complicated process that is influenced by a wide range of societal, healthcare, and individualized patient factors.
Once a drug is approved for sale in the United States, CDER tracks the use of marketed drugs for unexpected health risks. After approval, drugs are used by more patients with individual medical variations than can possibly be included in clinical trials, so it is impossible to know everything about the drug before its approval. The FDA continues to track approved drugs for harmful effects through a post-marketing tracking program known as the Adverse Event Reporting System or “AERS”. If new, unanticipated harms are detected after the drug has been approved for sale, CDER takes action to inform the public, change a drug's label, or even remove a product from the market. In addition to evaluating regular reports from manufacturers, the FDA's MedWatch program enables health care professionals and consumers to report suspected problems with their drugs.
8. How will this drug continue to be monitored for adverse events?
FDA and sanofi-aventis will continue to monitor the safety profile of Ketek. FDA is advising physicians to closely monitor patients for signs of liver problems and to tell patients about the chance for visual disturbances and loss of consciousness. Patients with myasthenia gravis should not take Ketek.