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Contaminated Nelfinavir Does Not Increase Cancer Risk, EMEA Concludes LONDON -- July 24, 2008 -- Following a review of a number of toxicology studies, the European Medicines Agency (EMEA) confirms that there is no increased risk of developing cancer for patients who have taken nelfinavir (Viracept) contaminated with ethyl mesilate. The EMEA's Committee for Medicinal Products for Human Use (CHMP) requested a number of toxicology studies to better assess the potential harm to patients using nelfinavir contaminated with ethyl mesilate. The studies showed that it is possible to calculate a threshold value below which ethyl mesilate does not cause any mutations in the DNA. The CHMP noted that patients or children born to mothers who had taken contaminated nelfinavir were exposed to ethyl mesilate levels well below this threshold and that, therefore, there was no increased risk of developing cancer for these patients compared with those patients who were not exposed to the contaminant. The Committee therefore concluded that there was no need to monitor patients who had been exposed to high levels of contaminated nelfinavir through specific patient registries. SOURCE: The European Medicines Agency E-mail this page to a friend or colleague! To print, use this version