FDA ALERT [3/16/2007]: FDA is issuing this alert to advise you of new emerging safety concerns about Zyvox (linezolid) from a recent clinical study. This open-label, randomized trial compared linezolid to vancomycin, oxacillin, or dicloxacillin (comparator antibiotics) in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. In this study, 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. FDA is currently evaluating the new study along with other information about linezolid.

What is Zyvox used for?
Zyvox is an antibiotic used to treat adults with certain bacterial infections. Zyvox does not work for viral infections (for example, the common cold).
General Precautions with Zyvox:
 Phenylketonuric patients should not take Zyvox oral suspension because it contains phenylalanine (a part of aspartame). The other Zyvox formulations do not contain phenylalanine.
 People taking Zyvox should avoid foods and beverages high in tyramine content. Health care professional can provide a list of foods and beverages containing tyramine.
What should I tell my doctor or health care provider?
Individuals should tell their doctor if they:
 have high blood pressure
 are taking any cold or decongestant medicines
 are taking a medication for depression
 are trying to become pregnant, are already pregnant, or are breast-feeding. The effects on the unborn child and nursing infant are unknown.
Because certain other medications can interact with Zyvox, review ALL medications that your are taking with your health care provider, including those that you take without a prescription
What are some possible side effects of Zyvox? (This is NOT a complete list of side effects reported with Zyvox. Your health care provider can discuss with you a more complete list of side effects.)
The side effects of Zyvox are generally mild, but serious side effects including decreased number of platelets, red blood cells, and white blood cells (myelosuppression) have been reported in people receiving Zyvox since it became available.
Other side effects may include:
 Diarrhea
 Headache
 Nausea
For more detailed information about Zyvox, ask your health care provider.

Date created: March 16, 2007