Assessment of Heavy Metal Contamination and Associated Health Risks in Drugs Administered to Newborns in Iraq
DOI:
https://doi.org/10.53560/PPASA(62-3)695Keywords:
Heavy Metals, Medical Drugs, Health Risks, New-born, CarcinogenAbstract
In this research, heavy metals such as lead (Pb), cadmium (Cd), and chromium (Cr) were determined in two types of drug samples, namely syrups and injections that were administered to newborns in Iraqi hospitals, during 2024. 30 samples of drugs were collected to investigate heavy metals using a Shimadzu AA-7000 atomic absorption spectrometer (AAS). The current study used the US Environmental Protection Agency model to calculate the carcinogen and non-carcinogen risk criteria for heavy metals in all medical samples. The average values of Pb, Cd, and Cr in syrup drug samples were 1.65 ± 0.47 mg/L, 0.34 ± 0.06 mg/L, and 1.17 ± 0.09mg/L, respectively. For injection drug samples, the corresponding average concentrations were 1.71 ± 0.45 mg/L, 0.45 ± 0.04 mg/L, and 1.26 ± 0.04 mg/L, respectively. All measured values of the concentrations of Pb, Cd, and Cr in syrup drug and injection drug were within international permissible limits; though, some injection samples showed elevated Pb levels. However, the TNCR and TCCR results for all samples were within the globally recommended limits by the US Environmental Protection Agency. Although measured concentrations of Pb, Cd, and Cr were within international permissible limits, carcinogenic and non-carcinogenic risk assessments indicate the need for continued monitoring of neonatal drugs, particularly those with elevated Pb levels.
References
1. A.A. Abojassim and R.R. Munim. Hazards of heavy metal on human health (Chapter 4). In: Research Trends in Multidisciplinary (vol 14). R. Jayakumar (Ed.). AkiNik Publications, New Delhi pp. 195 (2020).
2. V. Saxena. Water quality, air pollution, and climate change: Investigating the environmental impacts of industrialization and urbanization. Water Air Soil Pollution 236(2): 73-80 (2025).
3. V. Kumar, A. Sharma, and A. Cerda (Eds.). Heavy Metals in the Environment: Impact, Assessment, and Remediation. Elsevier, Amsterdam, Netherland (2020).
4. M. Blackwood (Ed.). Mold, mycotoxins, heavy metals, and parasites in chronic illness. Independently Published (2025).
5. E.C. Bair. A narrative review of toxic heavy metal content of infant and toddler foods and evaluation of United States policy. Frontiers in Nutrition 9: 919913 (2022).
6. E. Parente. Inorganic Impurities (Elemental Impurities) Chapter 14. In: Specification of Drug Substances and Products. C.M. Riley, T.W. Rosanske, and G.L. Reid (Eds.). Elsevier pp. 439-459 (2025).
7. D. Lledó, G. Grindlay, R. Serrano, L. Gras, and J.M. Sansano. Imidazolium-based task-specific ionic liquid for selective Ag, Cu, Pd and Pt determination by means of dispersive liquid-liquid microextraction and inductively coupled plasma optical emission spectrometry. Spectrochimica Acta Part B: Atomic Spectroscopy 204: 106672 (2023).
8. C. Giacomello. Children whose parents use drugs: Promising practices and recommendations. Council of Europe, Strasbourg, France (2022). https://rm.coe.int/2021-ppg-27-isbn-children-whose-parents-use-drugs-promising-practices-/1680a602ae
9. P. Nilesh, P. Sandeep, H. Dave. Regulatory Submission Templates for Elemental Impurities, Genotoxic Impurities, and Nitrosamine Impurities of Pharmaceutical Drug Substances. Asian Journal of Pharmaceutical Research and Health Care 16(4): 366-377 (2024).
10. D.J. Lawi, W.S. Abdulwhaab, and A.A. Abojassim. Health risk study of heavy metals from consumption of drugs (solid and liquid) samples derived from medicinal plants in Iraq. Biological Trace Element Research 201(7): 3528-3540 (2023).
11. Y. Yu, J. Xiang, Z. Meng, K.V. Jarnda, Q. Liu, and P. Ding. Residues of veterinary drugs and heavy metal contamination in livestock and poultry meat from Hunan Province, China. Food Additives & Contaminants: Part B 17(4): 360-370 (2024).
12. N.A. Bustami, C.K. Tan, Y.Z. Lee, R. Zaman, Y.B. Ho, and F. Amini. Evaluating Health Risks of Heavy Metals in Chinese Herbal Medicines Used by Pregnant and Postpartum Women in Kuala Lumpur, Malaysia. Malaysia. EnvironmentAsia 1: 15-22 (2025).
13. D.A. Skoog, F.J. Holler, and S.R. Crouch (Eds.). Principles of Instrumental Analysis (7th Edition). Cengage learning, United States (2018).
14. Z.L. He, X.E. Yang, and P.J. Stoffella. Trace elements in agroecosystems and impacts on the environment. Journal of Trace elements in Medicine and Biology 19(2-3): 125-140 (2005).
15. D.B. Hibbert (Ed.). Quality Assurance in The Analytical Chemistry Laboratory (1st Edition). Oxford University Press, New York (2007).
16. USEPA (United States Environmental Protection Agency). Microwave assisted acid digestion of siliceous and organically based matrices. EPA method 3052, (1996). https://19january2017snapshot.epa.gov/sites/production/files/2015-12/documents/3052.pdf
17. B.H. Ali and A.A. Abojassim. Comparative assessment of heavy metals in breast milk and canned milk consumed by Newborns in Al‑Najaf governorate, Iraq. Comparative Clinical Pathology in press (2025). https://doi.org/10.1007/s00580-025-03705-7
18. X. Liu, Q. Song, Y. Tang, W. Li, J. Xu, J. Wu, F. Wang and P.C. Brooke. Human Health Risk Assessment of Heavy Metals in the Soil-Vegetable System: A Multi-Medium Analysis. The Science of the Total Environment 463-464C: 530–540 (2013).
19. K. Sharafi, M. Yunesian, R.N. Nodehi, A.H. Mahvi, and M. Pirsaheb. A systematic literature review for some toxic metals in widely consumed rice types (domestic and imported) in Iran: Human health risk assessment, uncertainty and sensitivity analysis. Ecotoxicology and Environmental Safety 176: 64-75 (2019).
20. Pediatric Associates: Dosage Chart. Online document (2025). https://www.pediatricassociatesnyc.com/dosing-chart
21. A.I. Umar, Y. Sarkingobir, A. Faruk, M. Dikko, and H.W. Adamu. Extent of some heavy metals in cough syrups abused in Sokoto, Nigeria. Chulalongkorn Medical Journal 67(4): 251-256 (2024).
22. B.H. Ali and A.A. Abojassim. Health Risks Assessment from Heavy Metals in Care Products Materials for Newborns in Iraq. International Journal of Environmental Analytical Chemistry in press (2025). https://doi.org/10.1080/03067319.2025.2463992
23. M. de Onis. The WHO Child Growth Standards (Chapter 4.1). In: Pediatric Nutrition in Practice. B. Koletzko, J. Bhatia, Z.A. Bhutta, P. Cooper, M. Makrides, R. Uauy, and W. Wang (Eds.). Karger Publishers pp. 278-294 (2015).
24. U.S. Environmental Protection Agency. Baseline Human Health Risk Assessment for the Standard Mine Site, Gunnison County. Syracuse Research Corporation, Colorado (2008). https://semspub.epa.gov/work/08/1081025.pdf
25. Y. Fakhri, A. Mohseni-Bandpei, G.O. Conti, M. Ferrante, A. Cristaldi, A.K. Jeihooni, M.K. Dehkordi, H. Rasoulzadeh, A. Alinejad, S.M. Mohseni, M. Sarkhosh, H. Keramati, B. Moradi, N. Amanidaz, and Z. Baninameh. Systematic review and health risk assessment of arsenic and lead in the fished shrimps from the Persian Gulf. Food and Chemical Toxicology 113: 278-286. (2018).
26. U.S. Environmental Protection Agency. Baseline Human Health Risk Assessment for the Standard Mine Site Gunnison County, Colorado. Syracuse Research Corporation (2008). https://archive.epa.gov/hsrb/web/pdf/iris-2003-acrolein.pdf
27. U.S. Food and Drug Administration. FDA’s Testing of Cosmetics for Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury, and Nickel Content. U.S. Food and Drug Administration (2022). https://www.fda.gov/cosmetics/potential-contaminants-cosmetics/fdas-testing-cosmetics-arsenic-cadmium-chromium-cobalt-lead-mercury-and-nickel-content
28. United States Environmental Protection Agency. Calculating Upper Confidence Limits for Exposure Point Concentrations at Hazardous Waste Sites. Office of Emergency and Remedial Response, U.S. Environmental Protection Agency, Washington, DC, 20460, (2002). https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100CYCE.TXT
29. R. Kavlock and D. Dix. Computational Toxicology as Implemented by The US EPA: Providing High Throughput Decision Support Tools for Screening and Assessing Chemical Exposure, Hazard and Risk. Journal of Toxicology and Environmental Health Part B 13(2-4): 197-217 (2010).
30. United States Environmental Protection Agency. Guidance Manual for Assessing Human Health Risks from Chemically Contaminated Fish and Shellfish. Office of Water Regulations and Standards (OoWRa), Washington, D.C., United States (1989). https://nepis.epa.gov/Exe/ZyNET.exe/40001CR2.TXT?ZyActionD=ZyDocument&Client=EPA&Index=1986+Thru+1990&Docs=&Query=&Time=&EndTime=&SearchMethod=1&TocRestrict=n&Toc=&TocEntry=&QField=&QFieldYear=&QFieldMonth=&QFieldDay=&IntQFieldOp=0&ExtQFieldOp=0&XmlQuery=&File=D%3A%5Czyfiles%5CIndex%20Data%5C86thru90%5CTxt%5C00000017%5C40001CR2.txt&User=ANONYMOUS&Password=anonymous&SortMethod=h%7C-&MaximumDocuments=1&FuzzyDegree=0&ImageQuality=r75g8/r75g8/x150y150g16/i425&Display=hpfr&DefSeekPage=x&SearchBack=ZyActionL&Back=ZyActionS&BackDesc=Results%20page&MaximumPages=1&ZyEntry=1&SeekPage=x&ZyPURL
31. G.O. Olutona and J. Mulungi. Heavy Metals in Over-the-Counter Pediatric Drugs Locally Produced in Uganda: A Stare at Manganese, Lead, and Cadmium: Heavy metals in OTC pediatric drugs. Iranian Journal of Pharmaceutical Sciences 18(3): 235-243 (2022).
32. J.K. Nduka and O.E. Orisakwe. Heavy metal hazards of pediatric syrup administration in Nigeria: a look at chromium, nickel and manganese. International Journal of Environmental Research and Public Health 6(7): 1972-1979 (2009).
33. S. Şahin and V.A. Türksoy. The evaluation of potential toxic metal levels of various drugs used in children. Journal of Health Science and Medical Research 7(1): 39-46 (2024).
34. M.M. Hossain, S. Nahar, T.R. Choudhury, M. Shahriar, N. Uddin, A.F.M.M. Islam, A. Sarker, and P. Saha. Studies of heavy metal contents and microbial profile in selected pediatric oral liquid preparations available in Bangladesh. Journal of Pharmaceutical Research International 21(4):1-15 (2018).
