Regulatory toxicology and pharmacology : RTP
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Regul. Toxicol. Pharmacol. · Jul 2015
Hepatotoxicity induced by acute and chronic paracetamol overdose in adults. Where do we stand?
Paracetamol (Acetaminophen) poisoning data can reveal the potential deficiencies of paracetamol poisoning management guidelines. We conducted a retrospective cohort study of patients >18years who were attended in the emergency department (ED) of a Spanish tertiary hospital, from 2005 to 2010 for suspected paracetamol overdose and who had measurable paracetamol concentrations. 208 patients suspected of paracetamol poisoning were identified. The annual incidence in the ED increased from 2.0 (95%-CI: 0.2-7.2) cases per 10,000 patients in 2005 to 3.4 (95%-CI: 1.1-8.8) in 2010. ⋯ We conclude that the incidence of suspected cases of paracetamol poisoning at our hospital is increasing. The majority of toxicity cases, including ALF, associated with the ingestion of paracetamol were due to chronic poisoning. This finding constitutes an important warning regarding paracetamol chronic poisoning, and clinicians should have a higher index of clinical suspicion for this entity.
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Regul. Toxicol. Pharmacol. · Jun 2015
A longitudinal study of smokers' exposure to cigarette smoke and the effects of spontaneous product switching.
A challenge in investigating the effect of public health policies on cigarette consumption and exposure arises from variation in a smoker's exposure from cigarette to cigarette and the considerable differences between smokers. In addition, limited data are available on the effects of spontaneous product switching on a smoker's cigarette consumption and exposure to smoke constituents. Over 1000 adult smokers of the same commercial 10mg International Organization for Standardization (ISO) tar yield cigarette were recruited into the non-residential, longitudinal study across 10 cities in Germany. ⋯ Mouth level exposure decreased for smokers (n=111) who switched to cigarettes of 7mg ISO tar yield or lower. In addition, downward trends in mouth level exposure estimates were observed for smokers who did not switch cigarettes. Data from this study illustrate some of the challenges in measuring smokers' long-term exposure to smoke constituents in their everyday environment.
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Regul. Toxicol. Pharmacol. · Jun 2015
Safety evaluation of the human-identical milk monosaccharide, l-fucose.
l-Fucose is a natural monosaccharide present in mammals where it is found predominantly as an O-glycosidically linked component of glycoproteins, glycolipids, and oligosaccharides. It is also present in its free form in human breast milk (human milk monosaccharide). l-Fucose plays important roles in the development of the immune and nervous systems and is involved in cognitive function and memory formation. ⋯ During the subchronic phase, no compound-related adverse effects were observed in first generation rats at dietary levels of up to 1% (highest level tested), corresponding to doses of 516 and 665 mg/kg bw/day in males and females, respectively. l-Fucose was non-genotoxic in a series of in vitro genotoxicity/mutagenicity tests. These results support the safe use of l-fucose in infant formula and as a food ingredient at levels equivalent to those present in human breast milk.
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Regul. Toxicol. Pharmacol. · Apr 2015
Prescribing patterns of the four most commonly used sedatives in endoscopic examination in Korea: propofol, midazolam, diazepam, and lorazepam.
As the sedative use increases due to the effectiveness and relatively safe profile, the abuse potential is also increasing. This study was conducted to examine the usage of four sedative agents in endoscopic examination and to compare the propofol use with the other three sedatives. Using National Health Insurance claims data from 2008 to 2012, we identified the number of cases of conscious sedation during endoscopy using one or more of the following agents: propofol, midazolam, diazepam, and lorazepam. ⋯ While the majority of patients received an annual endoscopy, we identified several suspected abuse cases of patients receiving endoscopies repetitively as many as 114 times in five years. The rise of sedative use in endoscopic examinations and several patient cases of repeated sedative administration suggest a potential risk for abuse. Medical service providers should be cautious when using sedatives and carefully review each patient's medical history prior to the procedure.
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Regul. Toxicol. Pharmacol. · Apr 2015
Randomized Controlled Trial Multicenter Study Comparative StudyA study to investigate changes in the levels of biomarkers of exposure to selected cigarette smoke constituents in Japanese adult male smokers who switched to a non-combustion inhaler type of tobacco product.
In a clinical study, changes in 14 biomarkers of exposures (BOEs) from 10 tobacco smoke constituents and mutagens detected by the urine mutagenicity test were investigated using a non-combustion inhaler type of tobacco product (NCIT) by switching from a conventional cigarette. This study was conducted in 80 Japanese healthy adult males with a 4-week residential, controlled, open-label, parallel group design. After randomization, 40 smokers used NCIT with approximately 750 aspirations, other 20 smokers smoked approximately 20 pieces of an assigned 1-mg ISO tar conventional cigarette (CC1) every day. ⋯ On day 29, the levels of these BOEs were almost the same as those in the NS group, except BOEs of nicotine and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK). This suggested that the exposure to 8 constituents and mutagens in the NCIT group was similar to that in the NS group, while the exposure to nicotine was higher. Although the precise exposure level to NNK was not estimated because of the long half-life of its BOE, it would be substantially lower in the NCIT group than in the CC1 group.