PFIZER UPDATES ZYVOX LABELING IN THE EU

Pfizer recently updated physician labeling in the European Union (EU) for antibacterial agent Zyvox to reflect safety restrictions for use in patients with serious catheter-related bloodstream infections, the company said.

The firm will notify physicians of the safety signal and change to EU prescribing information via a "Dear Healthcare Provider" letter in the coming weeks, the company said. Pfizer noted that Zyvox (linezolid) is not indicated for catheter-related bloodstream infections.

Zyvox, part of the oxazolidinone class of antibacterial agents, is used to treat serious bacterial infections, including vancomycin-resistant infections and nosocomial pneumonia, as well as complicated and uncomplicated skin infections, including diabetic foot infections.

Separately, the British Medicines and Healthcare products Regulatory Agency announced March 7 that, at its request, Pfizer suspended advertising for Zyvox claiming the product had greater efficacy than vancomycin. The agency asserted that the ad made "potentially misleading claims," specifically that "Zyvox has superior cure rates compared with products containing the active ingredient vancomycin."