Ketek (telithromycin)

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.

Why Prescribed

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.

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FDA Approved Uses

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.

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Side Effects

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.

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Warnings and Alerts

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.

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Drug Contraindications

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).

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FAQ's

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 a “Changes Being Effected” (CBE) supplement?

A 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.

If I have been taking a drug that was not prescribed by a physician, do I still have a legal recourse for injuries suffered from these 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 drugs and medical devices?

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 been injured as the result of taking Ketek?

If you or a loved one has suffered health problems from using Ketek, you may be entitled to file a personal injury or wrongful death lawsuit against those responsible for the accident.

Damages sought against negligent persons and manufacturers for producing and selling products with safety defects include general and compensatory damages for:

• Past and future physical pain and suffering, mental anguish and physical impairment
• Past and future medical, incidental and hospital expenses
• Past and future loss of earnings and earning capacity, and
• Wrongful death when the injured person was killed.

For more information about your specific legal claim, consult with a drug litigation attorney who is experienced in trying defective drug cases.

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