Ketek (telithromycin) is a prescription antibiotic drug made by Aventis Pharmaceuticals indicated for the treatment of pneumonia, throat and sinus infections and chronic bronchitis, as well as serious or multi-drug resistant infections. Ketek is in a class of drugs called ketolide antibiotics, and is the first FDA-approved antibiotic of that class.
Ketek is prescribed for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia of mild to moderate severity– including pneumonia caused by resistant strep infections.
Ketek was approved in 2004 by the FDA to treat adults 18 years of age and older with certain respiratory (lung and sinus) infections caused by various bacteria.
Side effects associated with the use of Ketek include nausea, headache, dizziness, vomiting, and diarrhea. Ketek may cause problems with vision, particularly when looking quickly between objects close by and objects far away. Some patients have severe problems with vision that may interfere with normal activities. Ketek has also been associated with adverse side effects such as liver damage, liver cell damage, liver failure, and hepatitis.
In May 2006, the FDA recommended that a black box warning be added to the Ketek label, stating that “severe, life-threatening, and in some cases fatal” liver toxicity has been reported in patients taking the drug. The recommendation came after FDA safety reviewers found that Ketek has been linked to 12 cases of liver failure, including four deaths, in the U.S. In some cases, liver damage worsened rapidly and happened after just a few doses of Ketek.
While this FDA advisory panel did not recommend a Ketek recall, according to a December 13, 2006 report by CBS News, there is a new Congressional probe underway to determine whether Ketek should remain on the market.
Ketek is contraindicated in patients who have ever had a severe allergic reaction to any of the group of antibiotics known as macrolides such as erythromycin, azithromycin (Zithromax), clarithromycin (Biaxin) or dirithromycin (Dynabac), and/or are currently taking cisapride (Propulsid) or pimozide (Orap).
What actions were taken by the FDA after Ketek was linked to severe liver complications?
The FDA approved a labeling supplement submitted by Aventis Pharmaceuticals as a “Changes Being Effected” (CBE) supplement, which highlights the ‘Warnings’ section of the labeling to raise attention to the risk of liver toxicity associated with Ketek.
What is Supplement Changes Effected (CBE)?
Supplement Changes Effected CBE is a means available under FDA regulations to allow a company and the FDA to promptly address an important safety issue. This process allows a company and the FDA to expedite the review, approval process, and distribution for revised prescribing information when safety issues arise. A labeling supplement can be submitted to the FDA as a CBE for the following reasons:
- To add or strengthen a contraindication, warning, precaution, or adverse reaction
- To add or strengthen a statement about drug abuse, dependence, psychological effect, or over-dosage
- To add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product
- To delete false, misleading, or unsupported indications for use or claims for effectiveness, or
- Any labeling change normally requiring a supplement submission and approval prior to distribution of the drug product that FDA specifically requests be submitted under this provision.
Have you or someone you loved suffered from taking Non Prescribed Drugs?
In a case where no physician prescribed the drug which caused you injury, but instead you purchased it on your own, you may still have a claim against the drug manufacturer.
Does my doctor need to inform me of all options when it comes to prescription medicines?
You have the right to be told about all alternative courses of treatment, even if your health insurance may not cover them or you may not be able to afford them.
Can I file a lawsuit if I have suffered damages from taking Ketek?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Ketek, you should contact your doctor immediately. You may also wish to contact an experienced Ketek lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.