المؤلفون: Mitkus RJ; Office of Biostatistics and Epidemiology, USFDA Center for Biologics Evaluation and Research, Rockville, MD, USA., King DB, Walderhaug MO, Forshee RA

المصدر: Risk analysis : an official publication of the Society for Risk Analysis [Risk Anal] 2014 Apr; Vol. 34 (4), pp. 735-50. Date of Electronic Publication: 2013 Oct 10.

نوع المنشور: Comparative Study; Journal Article; Validation Study

بيانات الدورية: Publisher: Blackwell Publishers Country of Publication: United States NLM ID: 8109978 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1539-6924 (Electronic) Linking ISSN: 02724332 NLM ISO Abbreviation: Risk Anal Subsets: MEDLINE

مواضيع طبية MeSH: Influenza Vaccines/*administration & dosage , Mercury/*pharmacokinetics , Thimerosal/*administration & dosage, Area Under Curve ; Body Burden ; Humans ; Infant ; Influenza Vaccines/chemistry ; Thimerosal/analysis ; Uncertainty ; United States

مستخلص: The use of thimerosal preservative in childhood vaccines has been largely eliminated over the past decade in the United States because vaccines have been reformulated in single-dose vials that do not require preservative. An exception is the inactivated influenza vaccines, which are formulated in both multidose vials requiring preservative and preservative-free single-dose vials. As part of an ongoing evaluation by USFDA of the safety of biologics throughout their lifecycle, the infant body burden of mercury following scheduled exposures to thimerosal preservative in inactivated influenza vaccines in the United States was estimated and compared to the infant body burden of mercury following daily exposures to dietary methylmercury at the reference dose established by the USEPA. Body burdens were estimated using kinetic parameters derived from experiments conducted in infant monkeys that were exposed episodically to thimerosal or MeHg at identical doses. We found that the body burden of mercury (AUC) in infants (including low birth weight) over the first 4.5 years of life following yearly exposures to thimerosal was two orders of magnitude lower than that estimated for exposures to the lowest regulatory threshold for MeHg over the same time period. In addition, peak body burdens of mercury following episodic exposures to thimerosal in this worst-case analysis did not exceed the corresponding safe body burden of mercury from methylmercury at any time, even for low-birth-weight infants. Our pharmacokinetic analysis supports the acknowledged safety of thimerosal when used as a preservative at current levels in certain multidose infant vaccines in the United States.
(Published 2013. This article is a U.S. Government work and is in the public domain in the USA.)

المؤلفون: Forshee RA; Center for Food, Nutrition, and Agriculture Policy, University of Maryland-College Park, MD 20742, USA. rforshee@umd.edu, Storey ML, Ginevan ME

المصدر: Risk analysis : an official publication of the Society for Risk Analysis [Risk Anal] 2005 Oct; Vol. 25 (5), pp. 1121-35.

نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Blackwell Publishers Country of Publication: United States NLM ID: 8109978 Publication Model: Print Cited Medium: Print ISSN: 0272-4332 (Print) Linking ISSN: 02724332 NLM ISO Abbreviation: Risk Anal Subsets: MEDLINE

مواضيع طبية MeSH: Food Dispensers, Automatic* , Risk Assessment*, Carbonated Beverages/*adverse effects , Obesity/*etiology, Adolescent ; Body Mass Index ; Databases, Factual ; Humans ; Models, Statistical ; Obesity/epidemiology ; Obesity/prevention & control ; Risk Factors ; Schools ; Students ; United States/epidemiology

مستخلص: Risk analysis is a widely used tool to understand problems in food safety policy, but it is seldom applied to nutrition policy. We propose that risk analysis be applied more often to inform debates on nutrition policy, and we conduct a risk assessment of the relationship of regular carbonated soft drink (RCSD) consumption in schools and body mass index (BMI) as a case study. Data for RCSD consumption in schools were drawn from three data sets: the Continuing Survey of Food Intake by Individuals 1994-1996, 1998 (CSFII), the National Health and Nutrition Examination Survey 1999-2000 (NHANES), and the National Family Opinion (NFO) WorldGroup Share of Intake Panel (SIP) study. We used the largest relationship between RCSD and BMI that was published by prospective observational studies to characterize the maximum plausible relationship in our study. Consumption of RCSD in schools was low in all three data sets, ranging from 15 g/day in NFO-SIP to 60 g/day in NHANES. There was no relationship between RCSD consumption from all sources and BMI in either the CSFII or the NHANES data. The risk assessment showed no impact on BMI by removing RCSD consumption in school. These findings suggest that focusing adolescent overweight prevention programs on RCSD in schools will not have a significant impact on BMI.