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New Broad-Spectrum Antibiotic Tygacil[x] (tigecycline) Receives Approval for Use in Europe Today MAIDENHEAD, England, May 2/PRNewswire/ -- - Novel Antibiotic Provides New Weapon to European Hospitals in Battle Against Complicated Skin and Intra-Abdominal Infections Tygacil[x] (tigecycline) is the first antibiotic in a new class called glycylcyclines approved in Europe. Tygacil is produced by Wyeth and is indicated for use in complicated infections of the skin and soft tissue and complicated intra-abdominal infections acquired either in the hospital or in the community.[1] Tygacil has in vitro activity against many gram-positive and gram-negative bacteria, including multi-drug resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE).[1] It is estimated that there have been three million hospital-acquired infections per year in the extended EU, resulting in an alarming 50,000 deaths.[2] Inappropriate use of antibiotics has led to an increasing number of resistant pathogens across Europe; many of these organisms such as MRSA, have developed resistance to multiple antibiotics.[3] Hospital patients, as a result of their often weakened immune systems, are particularly vulnerable to these resistant strains, [4] developing infections that can manifest as infected burns, deep abscesses, surgical wound infections, perforations, or complicated appendicitis, among others. When these clinical complications are added to patients' existing medical conditions they can prove fatal or lead to longer stays in hospital, and therefore a greater burden on health care systems.[5] Tygacil is one of a limited number of new broad-spectrum antibiotics available in Europe. It is active against many gram-positive bacteria, such as MRSA, and common gram-negative pathogens, such as Escherichia coli. It can be used as empiric monotherapy (before the bacteria are identified) in the treatment of skin or intra-abdominal infections, especially those that may be caused by a mixture of different bacteria.[6] Professor Mark Wilcox, Clinical Director of Microbiology & Infection Control, Leeds Teaching Hospital, explains, "When a patient develops a serious infection in hospital it takes between 24 and 48 hours to pinpoint the bacteria responsible. It's vital, therefore, in these critical early stages of treatment, to have efficacious broad-spectrum antibiotics available. Tygacil is a useful new alternative broad spectrum antibiotic option." Tygacil was developed by Wyeth to overcome the two key tetracycline resistance mechanisms, efflux pumps and ribosomal protection, and is unaffected by other bacterial mechanisms of resistance such as extended spectrum beta-lactamases (ESBLs), which have limited the number of antibiotic options available. David McIntosh, Medical Director of Wyeth Pharmaceuticals comments, "The availability of Tygacil in Europe will provide physicians with an important new alternative in the treatment of complicated skin and intra-abdominal infections." He continues, "Since FDA approval in June 2005, Tygacil has been used in patient care in many US hospitals, and we are very pleased that patients in Europe will now be able to benefit from this new effective antibiotic." About Tygacil Tygacil will be launched in individual EU countries during 2006 and 2007, beginning with Germany and Austria. The drug is indicated for complicated infections of the skin and soft tissues and complicated intra-abdominal infections.[1] Tygacil received FDA approval in June 2005 and has since received regulatory approval in Brazil, Colombia, Argentina, Mexico, Peru, Ecuador, Kuwait, Qatar, and the Philippines. The most common adverse events reported in clinical trials with Tygacil were transient nausea (20%) and vomiting (14%). These occurred early and were generally mild or moderate in severity.[1] Notes About resistance mechanisms - Efflux pumps cause the antibiotic to be quickly pumped out of the bacteria, reducing the antibiotic's efficacy.[7] - Ribosomal protection blocks antibiotics from interfering with the bacteria's protein synthesis.[8] - This results in the bacteria becoming resistant and causes the antibiotic to become ineffective against the infection. (4/5/06) |