The Food and Drug Administration (FDA) recently announced its decision to restrict the use of the antibiotic Ketek (Telithromycin) based on reports of severe adverse effects associated with this drug.

Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. 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. However, not all respiratory infections are caused by bacteria. For example, common colds are caused by viruses. Ketek, like other antibiotics, does not kill viruses. 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.

Additionally, the FDA requires that the drug maker put on the label a "black box warning", FDA's strongest form of warning to indicate that Ketek should not be used in patients with myasthenia gravis, a disease that causes muscle weakness.

The FDA 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 risks associated with the use of Ketek 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.

The FDA requests that specific drug-related adverse events including visual disturbances and loss of consciousness are to be strengthened on the label warning. According to the FDA, warnings for hepatic toxicity (rare but severe symptoms of liver disease) were already strengthened in June 2006.

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 of a recently published article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin).

A patient should not use Ketek if he/she has ever previously 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).  Patients are also advised against using Ketek if currently taking cisapride (Propulsid) or pimozide (Orap).

Ketek has many reported side effects on the liver, including severe liver disease. In fact, in some cases, liver damage worsened rapidly and occurred after only 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.

It has been noted that there are several general warnings associates with the use of 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.

Before using Ketek, it is important to tell your healthcare provide if you have, or if a relative has, a rare heart condition known as congenital prolongation of the QT interval.  You should also tell your doctor is you 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).  Advise your doctor is you have 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.

Don’t forget to tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Some drugs should be stopped completely while using Ketek.  Those drugs include: cisapride (Propulsid) or pimozide (Orap), simvastatin, lovastatin, or atorvastatin (used for lowering cholesterol), medicines that correct heart rhythm called “antiarrhythmics” (such as quinidine, procainamide, or dofetilide), itraconazole, ketoconazole, midazolam, digoxin, 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 should not be taken while taking Ketek.

If you or a loved one has been injured by the use of Ketek, seek professional legal help from a Jim S. Adler and Associates personal injury attorney.  Fill out our form today for a free case review.