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Regulators and Regulations
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray
The FDA has the Regulatory authority to remedy Drug industry transgressions. A few are listed here: Drug Recall – An action imposed on a manufacturer to remove a product from the market that is defective. In 2019, OTC medicines containing ranitidine were removed because of levels of a possibly cancer-causing ingredient.Corrective Advertising – A company may be required to run Advertising to correct a prior ad which was found by FDA to be false, misleading, or incorrect.Off-Label Promotion – More than 30 such cases had been handled by 2020. They are subject to both criminal and civil actions.Corrective Action – To “improve a company practice”. This was applied in a DTC Promotion for the product, Yaz, incorrectly claimed to treat premenstrual tension.Debarment to prevent individuals from working in Drug development who have been involved in criminal conduct in Drug R&D.
Metabolic activation of zolmitriptan mediated by CYP2D6
Published in Xenobiotica, 2021
Lingling Han, Yudi Jia, Yanjia Zhao, Chen Sun, Min Zhao, Ying Peng, Jiang Zheng
Drug induced liver injury (DILI) is a significant cause of acute liver failure (ALF) and drug recall. The production of electrophilic reactive metabolites resulting from metabolic activation has been considered to be associated with DILI (Walgren et al. 2005; Leung et al. 2012; Hewitt et al. 2013), for example, benzbromarone (Wang et al. 2017), erlotinib (Stepan et al. 2011), nitrofurantoin (Li et al. 2019). It was reported that compounds with more significant hepatic metabolism cause DILI at greater frequency, which suggests that the close relationship between drug metabolism and hepatotoxicity (Lammert et al. 2010). Zolmitriptan is mainly metabolized in the liver, and the present study was designed to investigate the metabolic activation of ZOL mediated by cytochrome P450s in vitro and in vivo.