United States of America - The Food and Drug Administration (FDA) has approved tigecycline (Tygacil®), a novel I.V. antibiotic with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA) which provides a treatment alternative for complicated skin and intra-abdominal Infections in adults. Approval of this first-in-class product comes at a time when the need for new antibiotic options to combat serious, resistant infections is increasing. Tigecycline is the first antibiotic approved in a new class called glycylcyclines, developed to overcome key mechanisms of resistance that have affected antibiotic use.

The FDA was provided with data from four pivotal phase III studies examining the safety and efficacy of tigecycline for the treatment of cIAI and cSSSI. The submission also included in vitro data showing activity against both Gram-negative and Gram-positive bacteria, anaerobes, and certain drug-resistant pathogens. The manufacturer now awaits decisions on approval of tigecycline from other regulatory bodies including those in the European Union, Australia, Brazil, Canada, Colombia, Mexico, South Africa, Switzerland, Taiwan, and Venezuela.

Tigecycline is contraindicated in patients with known hypersensitivity and administered with caution in patients with known hypersensitivity to tetracycline class antibiotics. In clinical trials, the most common treatment-emergent adverse events were nausea (29.5 percent) and vomiting (19.7 percent).

Tigecycline may cause fetal harm when administered to a pregnant woman. Safety and effectiveness in patients below age 18 and lactating women have not been established. Use of tigecycline during tooth development may cause permanent discoloration of the teeth. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life threatening. Monotherapy should be used with caution in patients with clinically apparent intestinal perforation.

Reference: Communication from Wyeth 15 June 2005 at http://www.wyeth.com