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 Table of Contents    
Year : 2011  |  Volume : 43  |  Issue : 4  |  Page : 486-487

Authors' reply

1 Department of Pharmacology, Army College of Medical Sciences, Delhi, India
2 Department of Pharmacology, BJ Medical College, Ahmedabad, India

Date of Web Publication22-Jul-2011

Correspondence Address:
Sapna Pradhan
Department of Pharmacology, Army College of Medical Sciences, Delhi
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Source of Support: None, Conflict of Interest: None

PMID: 21845018

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How to cite this article:
Pradhan S, Shah U H, Mathur A, Sharma S. Authors' reply. Indian J Pharmacol 2011;43:486-7

How to cite this URL:
Pradhan S, Shah U H, Mathur A, Sharma S. Authors' reply. Indian J Pharmacol [serial online] 2011 [cited 2023 Jun 2];43:486-7. Available from: https://www.ijp-online.com/text.asp?2011/43/4/486/83132


We would like to thank the authors [1] for the keen interest shown in our paper. [2]

(a) The authors have a query that the route of administration of aspartame and paracetamol has not been mentioned. We wish to submit that both aspartame and paracetamol were administered by the intraperitoneal route. This fact has been mentioned in [Table 1], but missed a mention in the text.

(b) Regarding the issue about the carcinogenic effect of aspartame seen in doses of 20 mg/kg bw, [3] it is submitted that in our study, statistically significant antipyretic and analgesic effects were observed at low doses of 4 and 8 mg/kg bw. An 18-membered scientific panel, consisting of independent regulatory scientists and toxicologists, constituted by the European Food Safety Authority (EFSA), has concluded that the data on total malignant tumors does not provide evidence of a carcinogenic potential of aspartame. [4] These findings have been reiterated by similar studies. [5],[6] In view of the public concerns about the toxicity of aspartame, the Scientific Committee on Food, European Commission Health and Consumer Protection Directorate-General conducted a safety review and concluded from the biochemical, clinical and behavioral research that the acceptable daily intake of 40 mg/kg/day of aspartame is entirely safe-except for in people with phenylketonuria. [7] Intakes over 1 g/day are needed to alter brain neurotransmitters and provoke seizures in monkeys, and randomized controlled trials of high doses in humans have not shown any behavioral or other effects. [8],[9] Acute, subacute and chronic toxicity studies with aspartame, and its decomposition products, conducted in mice, rats, hamsters and dogs, have consistently found no adverse effect of aspartame with doses up to at least 4000 mg/kg bw/day. [5]

When all the research on aspartame, including evaluations in both the pre-marketing and post-marketing periods, is examined as a whole, it appears that aspartame is safe. [8],[9],[10],[11],[12]

However, detailed pharmacological studies for long-term safety evaluation are strongly recommended to evaluate the potential therapeutic use of aspartame.

(c) The observation that aspartame is a non-nutritive time sweetener is factually correct. The term "non" appears to have been missed out during the preparation of the manuscript, and the omission is regretted.

  References Top

1.Tandel KR. Experimental evaluation of antipyretic and analgesic activities of aspartame. Indian J Pharm 2011;43:486.  Back to cited text no. 1
2.Pradhan S, Shah UH, Mathur A, Sharma S. Experimental evaluation of antipyretic and analgesic activity of aspartame. Indian J Pharm 2011;43:89-90.  Back to cited text no. 2
3.Soffritti M, Belpoggi F, Degli Esposti D, Lambertini L, Tibaldi E, Rigano A. First experimental demonstration of the multipotential carcinogenic effects of aspartame administered in the feed to Sprague-Dawley rats. Environ Health Perspect 2006;114:379-85.  Back to cited text no. 3
4.Abegaz EG. Aspartame not linked to cancer. Environ Health Perspect 2007;115:A16-7.  Back to cited text no. 4
5.Magnuson BA, Burdock GA, Doull J, Kroes RM, Marsh GM, Pariza MW, et al. Aspartame: A safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies. Crit Rev Toxicol 2007;37:629-727.  Back to cited text no. 5
6.Weihrauch MR, Diehl V. Artificial sweeteners-Do they bear a carcinogenic risk? Ann Oncol 2004;15:1460-5.   Back to cited text no. 6
7.European Commission. Health and Consumer Protection Directorate-General, Scientific Committee on Food. Opinion of the scientific committee on food: Update on the safety of aspartame. SCF, 10 December 2002.  Back to cited text no. 7
8.Butchko HH, Stargel WW. Aspartame: Scientific evaluation in the postmarketing period. Regul Toxicol Pharmacol 2001;34:221-33.  Back to cited text no. 8
9.Wolraich ML, Lindgren SD, Stumbo PJ, Stegink LD, Appelbaum MI, Kiritsy MC. Effects of diets high in sucrose or aspartame on the behavior and cognitive performance of children. N Engl J Med 1994;330:301-7.  Back to cited text no. 9
10.Butchko HH, Stargel WW, Comer CP, Mayhew DA, Benninger C, Blackburn GL, et al. Aspartame: Review of safety. Regul Toxicol Pharmacol 2002;35:S1-93.  Back to cited text no. 10
11.Lean ME, Hankey CR. Aspartame and its effects on health. BMJ 2004;329:755-6.  Back to cited text no. 11
12.Spiers PA, Sabounjian L, Reiner A, Myers DK, Wurtman J, Schomer DL. Aspartame: Neuropsychologic and neurophysiologic evaluation of acute and chronic effects. Am J Clin Nutr 1998;68:531-7.  Back to cited text no. 12


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