Elevated ethyl methanesulfonate (EMS) in nelfinavir mesylate (Viracept®, Roche): Overview

AIDS Research and Therapy

Volumn 6, Issue , 2009, Pages

  Pozniak, Anton ^a   Müller, Lutz ^b   Salgo, Miklos ^b   Jones, Judith K ^c   Larson, Peter ^d   Tweats, David ^e  

^a CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

^c Degge Group   (United States)

^d Pharmaceuticals Division   (United States)

^e UNIVERSITY OF WALES   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

MESYLIC ACID ETHYL ESTER; NELFINAVIR;

ALKYLATION; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BLOOD CELL COUNT; CARCINOGENICITY; CHROMOSOME DAMAGE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DNA DAMAGE; DNA REPAIR; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; FEMALE; GENE MUTATION; GENOTOXICITY; MALE; MAXIMUM PLASMA CONCENTRATION; MICRONUCLEUS TEST; MOUSE; NONHUMAN; ORGAN SIZE; ORGAN WEIGHT; PRIORITY JOURNAL; RAT; RISK ASSESSMENT; TERATOGENICITY; TRANSGENIC MOUSE;

EID: 69549108321     PISSN: 17426405     EISSN: None     Source Type: Journal    
DOI: 10.1186/1742-6405-6-18     Document Type: Article

References (11)

1. Gerber C Toelle H-G What happened: The chemistry side of the incident with EMS contamination in Viracept tablets Toxicol Lett 2009.
2. Jacinto FV Esteller M MGMT hypermethylation: A prognostic foe, a predictive friend DNA repair 2007, 6:1155-1160. 10.1016/ j.dnarep.2007.03.013 17482895
3. Doak SH Jenkins GJS Johnson GE Quick E Parry EM Parry JM Mechanistic influences for mutation induction curves after exposure to DNA-reactive carcinogens Cancer Res 2007, 67:3904-3911. 10.1158/0008-5472.CAN-06-4061 17440105
4. Pfister T Eichinger-Chapelon A General 4-week toxicity study with EMS in the rat Toxicol Lett 2009.
5. Gocke E Ballantyne M Whitwell J Müller L MNT and MutaMouse studies to define the in vivo dose response relations of the genotoxicity of EMS and ENU Toxicol Lett 2009.
6. Gocke E Müller L In vivo studies in the mouse to define a threshold for the genotoxicty of EMS and ENU Mutation Research 2009. 19376265
7. Gocke E Wall M In vivo genotoxicity of EMS: Statistical assessment of the dose response curves Toxicol Lett 2009.
8. Lave T Birnböck H Götschi A Ramp T Pähler A In vivo and in vitro characterization of ethylmethanesulfonate pharmacokinetics in animals and in human Toxicol Lett 2009. 19443141
9. Lavé T Päehler A Grimm HP Modelling of patient EMS exposure: translating pharmacokinetics of EMS in vitro and in animals into patients Toxicol Lett 2009.
10. Müller L Gocke E Lavé T Pfister T Ethyl methanesulfinate toxicity in Viracept - a comprehensive human risk assessment based on threshold data for genotoxicity Toxicol Lett 2009.
11. European Medicines Agency Press Release July 24, 2008. Studies assessed by the EMEA indicate no increased risk of developing cancer for patients who have taken Viracept contaminated with ethyl mesilate http://www.emea.europa.eu/humandocs/PDFs/EPAR/Viracept/38225608en.pdf