Case Evaluation

Ketek: Ketek Overview

What is Ketek?

Ketek (telithromycin) is an antibiotic medication that is used to treat certain respiratory infections caused by bacteria, such as bronchitis and pneumonia. While Ketek kills many types of bacteria that infect the lungs and sinuses, it does not kill viruses, such as those that cause the common cold.

Ketek is manufactured by Sanofi-Aventis and was approved by the U.S. Food and Drug Administration (FDA) in April 2004.

Ketek Special Warnings

There have been reports of severe liver disease associated with Ketek use. In some cases, liver damage occurred or worsened rapidly 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 using Ketek and contact your healthcare professional immediately.

If you have myasthenia gravis, talk to your healthcare professional about other treatments before taking Ketek. If you are taking Ketek and your myasthenia gravis symptoms worsen (such as muscle weakness or difficulty breathing), you should stop taking Ketek and seek immediate medical attention.

General Precautions with Ketek

You must not take Ketek if you:

  • have ever had a severe allergic reaction to (or have experienced liver-related side effects while taking) Ketek or any antibiotics known as "macrolides," such as erythromycin, azithromycin (Zithromax), clarithromycin (Biaxin) or dirithromycin (Dynabac)
  • are currently taking cisapride (Propulsid) or pimozide (Orap)

Ketek may cause vision problems, particularly when looking quickly between objects close by and objects far away. Problems include blurred vision, double vision, and difficulty focusing. Although most reported problems are mild to moderate, some patients experience severe vision problems that may interfere with normal activities. These problems lasted several hours and, in some patients, repeated with subsequent doses.

If you are taking Ketek, be careful when driving a motor vehicle, operating heavy machinery, or engaging in otherwise hazardous activities.

What Should I Tell My Healthcare Professional?

Tell your healthcare professional 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, plan 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

Ketek Food and Drug Interactions

Tell your healthcare provider about all prescription and/or nonprescription medicines you take, including vitamins, and herbal supplements.

Especially, tell your healthcare provider if you take:

  • cisapride (Propulsid) or pimozide (Orap); and 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
    • warfarin and other oral anticoagulants (sometimes called blood thinners)
    • diuretics (also sometimes called water pills) such as furosemide or hydrochlorothiazide

What Are the Side Effects Associated with Ketek?

Ketek may cause side effects. Tell your healthcare professional if any of the following symptoms are severe and/or persistent:

  • diarrhea
  • upset stomach
  • headache
  • dizziness
  • vomiting
  • loose stools
  • changes in ability to taste
  • blurred vision

Some side effects can be serious. If you experience any of these symptoms call your healthcare professional immediately:

  • fainting
  • rapid, irregular, or pounding heartbeat
  • extreme tiredness
  • unusual bleeding or bruising
  • lack of energy
  • loss of appetite
  • pain in the upper right part of the stomach
  • yellowing of the skin or eyes
  • flu-like symptoms
  • hives
  • rash
  • itching
  • difficulty breathing or swallowing
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness

Ketek - Getting Legal Help

While all medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions while using Ketek, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Ketek use.

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