European Medicines Agency London, 4 December 2006 Product Name: POSACONAZOLE SP Procedure number: EMEA/H/C/611/II/01 authorised SCIENTIFIC DISCUSSION longer no product Medicinal 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail:
[email protected] http://www.emea.europa.eu 1 Introduction Fungal infections are a major cause of morbidity and mortality in immunocompromised patients. Filamentous mould and yeast-like fungi are ubiquitous organisms found worldwide in many different media. The Candida species are the most common cause of fungal infections. However, epidemiologic shifts have begun to occur, most likely due to the prophylactic and empiric use of antifungal agents. Emerging fungal pathogens, such as Aspergillus, Fusarium, and Zygomycetes, are changing the clinical spectrum of fungal diagnoses. Pathogens General risk factors for invasive fungal infections are exposure to pathogens, an impaired immune system, and fungal spores. The presence of a colonised environment, partnered with a disruption in a physiologic barrier, potentiates the risk of an invasive fungal infection in an immunologically impaired host, such as a patient infected with HIV, someone taking chronic systemic steroids, or a transplant recipient. In addition, contaminated implanted devices (e.g., catheters, prostheses), external devices (e.g., contact lenses), and community reservoirs (e.g., hand lotion, pepper shakers) have all been implicated as sources of fungal outbreaks. Candida albicans continues to be the most frequent cause of invasive fungal infections in most patient populations. However, prophylaxis and the widespread use of antifungal agents as empiric therapy for neutropenic fever have led to a shift in the epidemiology of invasive Candida infections.