EMS in Viracept--the course of events in 2007 and 2008 from the non-clinical safety point of view.

摘要: Viracept (nelfinavir) is an HIV protease inhibitor supplied by Roche outside the US, Canada and Japan. was first introduced in 1998. Although newer inhibitors have become available for treatment of HIV, it viewed as a useful medicine patients who are intolerant to ritonavir (since does not require boosting), pregnant women, resource-limited settings, since formulation heat-stable refrigeration. The relatively high prevalence some third world countries means that also product choice young women childbearing age, nursing children. On 18 May 2007 F. Hoffmann-La received reports "bad smell" blisterpacked tablets one adverse drug report nausea vomiting from Spain. Subsequently, ethyl methanesulfonate (EMS), established mutagen, carcinogen teratogen identified potential source bad smell. 6 June 2007, globally recalled extent contamination exceeded guidances permissible levels set regulatory authorities more than 1000-fold hence human risk readily assessable. In following, compilation course events non-clinical point view presented. This only partially reflects complexity case interactions between all parties May/June September 2008 necessarily remains partly subjective authors this article. serves introduction into Special Issue Toxicology Letters. data on cause contamination, likely duration intake affected patient population can be found subsequent contributions. Most importantly, we share other parts with scientific community assessment arguments supported conclusion company EMS posed no health patients.