The antibiotic Ketek was originally approved in 2004 and is manufactured by Sanofi Aventis. From now on, the drug is no long indicated for use in patients with acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis.

However, Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity, which is acquired outside of hospitals or long-term care facilities.

In addition, the FDA requires that the drug maker put on the label a "boxed warning", FDA's strongest form of warning to indicate that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness.

The federal agency also worked with the manufacturer to develop a Patient Medication Guide, which is to be distributed along with each prescription, to inform patients of the risk of the drug and advise them how to use it safely.

"Today's action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research.

Specific drug-related adverse events including visual disturbances and loss of consciousness are to be strengthened on the label. Warnings for hepatic toxicity (rare but severe symptoms of liver disease) were already strengthened in June 2006, according to the FDA.

A joint advisory committee comprised of FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory committees advised that the benefits of the drug outweigh its risk for patients with community acquired pneumonia.

But they said for patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis, the risk is too great to allow the antibiotic for these conditions.   

The committee also recommended a boxed warning as well as Medication Guide for the drug.

On January 20, 2006, the FDA advised the public that the Annals of Internal Medicine had published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin).

These cases had also been reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan.

This is a summary of the most important information about Ketek. For details, talk to your healthcare professional.

What is Ketek used for?

Ketek is an antibiotic used to treat adults 18 years of age and older with certain respiratory (lung and sinus) infections caused by certain germs called bacteria. Ketek kills many of the types of bacteria that can infect the lungs and sinuses, and has been found to treat these infections safely and effectively in clinical trials. Not all respiratory infections are caused by bacteria. For example, common colds are caused by viruses. Ketek, like other antibiotics, does not kill viruses.

Who should not take Ketek?

 You must not take Ketek if you:

      * have ever had a severe allergic reaction to Ketek or to any of the group of antibiotics known as “macrolides” such as erythromycin, azithromycin (Zithromax), clarithromycin (Biaxin) or dirithromycin (Dynabac).     

    * are currently taking cisapride (Propulsid) or pimozide (Orap).       

    * have ever experienced side effects on the liver while taking Ketek or other antibiotics called macrolides (erythromycin, clarithromycin or azithromycin).

There have been reports of side effects on the liver, including severe liver disease. In some cases, liver damage worsened rapidly and happened after just a few doses of Ketek. If you develop signs or symptoms of hepatitis (liver disease), such as tiredness, body aches, loss of appetite, nausea, jaundice (yellow color of the skin and/or eyes), dark urine, light-colored stools, itchy skin, or belly pains, stop your medication and immediately contact your healthcare provider.

If you have myasthenia gravis, you should talk to your healthcare provider about other treatments before taking Ketek. There have been reports of worsening of myasthenia gravis symptoms in patients with myasthenia gravis taking Ketek. If you have myasthenia gravis and experience worsening of your symptoms (such as muscle weakness, difficulty breathing) during treatment with Ketek, you should stop taking Ketek and seek immediate medical attention.

General Precautions with Ketek:

    * Ketek may cause problems with vision, particularly when looking quickly between objects close by and objects far away. These events include blurred vision, difficulty focusing, and objects looking doubled. Some patients have severe problems with vision that may interfere with normal activities.   Most events were mild to moderate; however, severe cases have been reported.   These problems lasted several hours and in some patients come back with the next dose. People taking Ketek should be careful when driving a motor vehicle, operating heavy machinery, or engaging in otherwise hazardous activities.       

    * There have been reports of side effects on the liver. Signs of jaundice include yellow color of the skin and/or eyes.

What should I tell my healthcare provider?

 Tell your healthcare provider if you:

      * have, or if a relative has, a rare heart condition known as congenital prolongation of the QT interval.       

    * are being treated for heart rhythm disturbances with certain medicines known as antiarrhythmics (such as quinidine, procainamide, or dofetilide), or if you have low blood potassium (hypokalemia), or low blood magnesium (hypomagnesemia)       

    * have a disease known as myasthenia gravis.       

    * are pregnant, planning to become pregnant, or are nursing.       

    * have ever experienced jaundice (yellow color of the skin and/or eyes) while taking Ketek.       

    * have any other serious medical conditions, including heart, liver, or kidney disease.  

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.   Especially tell your healthcare provider if you take:

    * cisapride (Propulsid) or pimozide (Orap).       

    * simvastatin, lovastatin, or atorvastatin (used for lowering cholesterol). You should stop treatment with these medications while you are taking Ketek.       

    * medicines that correct heart rhythm called “antiarrhythmics” (such as quinidine, procainamide, or dofetilide).       

    * any of the following medicines: itraconazole, ketoconazole, midazolam, digoxin, ergot alkaloid derivatives, cyclosporine, carbamazepine, hexobarbital, phenytoin, tacrolimus, sirolimus, metoprolol, theophylline, rifampin, or warfarin and other oral anticoagulants (sometimes called blood thinners).       

    * medicines called diuretics (also sometimes called water pills) such as furosemide or hydrochlorothiazide.

 What are some possible side effects of Ketek? (This list is NOT a complete list of side effects reported with Ketek.   Your healthcare provider can discuss with you a more complete list of side effects.)

The most common side effects of Ketek include:

    * nausea       

    * headache       

    * dizziness       

    * vomiting       

    * diarrhea. If diarrhea persists call your healthcare provider.   
 

For more detailed information about Ketek, ask your healthcare provider or pharmacist.

This is historical information only.
The information in this sheet has been updated and is addressed in product labeling including a MedGuide for patients. http://www.fda.gov/cder/foi/label/2007/021144s012medg.pdf