Drug Notebook

FDA Alerts

Special Alerts:

[Posted 03/16/2007] FDA notified healthcare professionals of new emerging safety concerns about linezolid (Zyvox) from a recent clinical study. This open-label, randomized trial compared linezolid to vancomycin, oxacillin, or dicloxacillin in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. Patients treated with linezolid had a higher chance of death than did patients treated with any comparator antibiotic, and the chance of death was related to the type of organism causing the infection. Patients with Gram positive infections had no difference in mortality according to their antibiotic treatment. In contrast, mortality was higher in patients treated with linezolid who were infected with Gram negative organisms alone, with both Gram positive and Gram negative organisms, or who had no infection when they entered the study.

Linezolid is not approved for the treatment of catheter-related bloodstream infections, catheter-site infections, or for the treatment of infections caused by Gram negative bacteria. If infection with Gram negative bacteria is known or suspected, appropriate therapy should be started immediately. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zyvox and http://www.fda.gov/cder/drug/infopage/linezolid/default.htm.

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linezolid
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(lin EZ oh lid)

What is the most important information I should know about linezolid?

Before taking linezolid, tell your doctor if you have high blood pressure, a seizure disorder, a thyroid or adrenal gland disorder, kidney or liver disease, bone marrow suppression, or a weak immune system.

Take linezolid for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

While you are using linezolid, avoid taking an "SSRI" antidepressant without telling your doctor. This includes Celexa, Lexapro, Prozac, Luvox, Paxil, or Zoloft. Taking an SSRI antidepressant together with linezolid can cause symptoms such as anxiety, high fever, sweating, chills or goosebumps, memory problems, trouble concentrating, loss of coordination, or muscle spasms.

Eating tyramine while you are taking linezolid can raise your blood pressure to dangerous levels. Avoid foods that have a high level of tyramine, such as aged cheeses or meats, pickled or fermented meats, smoked or air-dried meats, sauerkraut, soy sauce, tap beer, red wine, or any meat, cheese, or other protein-based food that has been improperly stored.

You should become very familiar with the list of foods you must avoid while you are taking linezolid.

What is linezolid?

Linezolid is an antibiotic that fights bacteria in the body.

Linezolid is used to treat different types of bacterial infections, such pneumonia, skin infections, and infections that are resistant to other antibiotics.

Linezolid may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking linezolid?

Linezolid may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Do not use this medication if you are allergic to linezolid.

Before taking linezolid, tell your doctor if you are allergic to any drugs, or if you have:

  • high blood pressure;

  • epilepsy or other seizure disorder;

  • a thyroid or adrenal gland disorder;

  • kidney disease;
  • liver disease; or
  • bone marrow suppression or a weak immune system.

If you have any of these conditions, you may not be able to use linezolid, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether linezolid passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The oral suspension (liquid) form of linezolid may contain phenylalanine. Talk to your doctor before using this form of linezolid if you have phenylketonuria (PKU).

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