Investigating the Detection of Undeclared Cyproheptadine in Weight Gain Herbal Supplements, Creajensing
International Journal of Medical Toxicology and Forensic Medicine,
Vol. 14 No. 02 (2024),
24 April 2024
https://doi.org/10.32598/ijmtfm.v14i02.43922
Abstract
Background: Nowadays many people depend on herbal medicine for their healthcare needs; however, handmade herbal drugs are not screened for efficacy and safety. Undeclared active pharmaceutical ingredients have been detected in herbal medicine, even if there are claims to be natural. This study determines the undeclared active pharmaceutical ingredients in a weight gain herbal supplement collected from an Iranian online herbal shop.
Methods: One packet of herbal supplement (containing 45 tablets), advised as a weight gain product, was gathered from an online herbal shop in Iran. The sample was analyzed to detect undeclared active pharmaceutical ingredients using gas chromatography/mass spectrometry instrument, based on Iranian forensic standard operating procedures 920118-2655.
Results: The cyproheptadine was detected in this herbal supplement at a concentration higher than the therapeutic dose.
Conclusion: Although synthetic drugs cannot be produced except by permission of the licensing authorities, there is no regulation for herbal supplement production in Iran. Therefore, herbal supplements’ serious quality and safety concerns must be assured for patients’ health.
- Weight gain supplement
- Serotonin antagonist
- Histamine antagonist
- Adulteration
- Cyproheptadine
How to Cite
References
Kumar G, Jalaluddin M, Rout P, Mohanty R, Dileep CL. Emerging trends of herbal care in dentistry. Journal of Clinical and Diagnostic Research. 2013; 7(8):1827-9. [DOI:10.7860/JCDR/2013/6339.3282] [PMID] [PMCID]
Skalli S, Jordan SA. Herbal and traditional medicines, now and future. In: Edwards IR, Lindquist M, editors. Pharmacovigilance. Berlin: Springer; 2017. [DOI:10.1007/978-3-319-40400-4_14]
Jung J, Hermanns-Clausen M, Weinmann W. Anorectic sibutramine detected in a Chinese herbal drug for weight loss. Forensic Science International. 2006; 161(2-3):221-2. [DOI:10.1016/j.forsciint.2006.02.052] [PMID]
Posadzki P, Watson L, Ernst E. Contamination and adulteration of herbal medicinal products (HMPs): An overview of systematic reviews. European Journal of Clinical Pharmacology. 2013; 69(3):295-307. [DOI:10.1007/s00228-012-1353-z] [PMID]
Routledge PA. The European Herbal Medicines Directive: Could it have saved the lives of Romeo and Juliet? Drug Safety. 2008; 31(5):416-8. [DOI:10.2165/00002018-200831050-00006] [PMID]
Brown AC. An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series. Food and Chemical Toxicology. 2017; 107(Pt A):449-71. [DOI:10.1016/j.fct.2016.11.001] [PMID]
Foroughi MH, Akhgari M, Jokar F, Mousavi Z. Identification of undeclared active pharmaceutical ingredients in counterfeit herbal medicines used as opioid substitution therapy. Australian Journal of Forensic Sciences. 2017; 49(6):720-9. [DOI:10.1080/00450618.2016.1273387]
Höllein L, Kaale E, Mwalwisi YH, Schulze MH, Holzgrabe U. Routine quality control of medicines in developing countries: Analytical challenges, regulatory infrastructures and the prevalence of counterfeit medicines in Tanzania. TrAC Trends in Analytical Chemistry, 2016; 76:60-70. [DOI:10.1016/j.trac.2015.11.009]
Mackey TK, Liang BA, York P, Kubic T. Counterfeit drug penetration into global legitimate medicine supply chains: A global assessment. The American Journal of Tropical Medicine and Hygiene. 2015; 92(6 Suppl):59-67. [DOI:10.4269/ajtmh.14-0389] [PMID] [PMCID]
Lee JY, Kim HC, Kim C, Park K, Ahn SV, Kang DR, et al. Underweight and mortality. Public Health Nutrition. 2016; 19(10):1751-6. [DOI:10.1017/S136898001500302X] [PMID] [PMCID]
Park J, Han S, Jang HD, Shin G, Han K, Hong JY. Underweight as a risk factor for vertebral fractures in the South Korean population. The Spine Journal. 2023; 23(6):877-84. [DOI:10.1016/j.spinee.2023.02.015] [PMID]
Mak KK, Tan SH. Underweight problems in Asian children and adolescents. European Journal of Pediatrics. 2012; 171(5):779-85. [DOI:10.1007/s00431-012-1685-9] [PMID]
Pourabdian S, Golshiri P, Janghorbani M. Overweight, underweight, and obesity among male long-distance professional drivers in Iran. Journal of Occupational Health. 2020; 62(1):e12114. [DOI:10.1002/1348-9585.12114] [PMID] [PMCID]
Mohseni M, Ahmadi S, Asadi H, Mohammadian ED, Asgarlou Z, Ghazanfari F, et al. A systematic review and meta-analysis of the prevalence of malnutrition among 6-14-year-old children in Iran. International Journal of Preventive Medicine. 2022; 13:138. [DOI:10.4103/ijpvm.IJPVM_564_20] [PMID] [PMCID]
Jalali-Farahani S, Chin YS, Amiri P, Mohd Taib MN. Body mass index (BMI)-for-age and health-related quality of life (HRQOL) among high school students in Tehran. Child: Care, Health and Development. 2014; 40(5):731-9. [DOI:10.1111/cch.12103] [PMID]
Fitzpatrick KK, Lock J. Anorexia nervosa. BMJ Clinical Evidence. 2011; 2011:1011. [PMID] [PMCID]
Halmi KA, Eckert E, LaDu TJ, Cohen J. Anorexia nervosa. Treatment efficacy of cyproheptadine and amitriptyline. Archives of General Psychiatry. 1986; 43(2):177-81. [DOI:10.1001/archpsyc.1986.01800020087011] [PMID]
Fakhri S, Mohammadi B, Jalili R, Hajialyani M, Bahrami G. Screening and confirmation of different synthetic adulterants in slimming products. Asian Journal of Pharmaceutical and Clinical Research. 2018. 11(2):260-4. [DOI:10.22159/ajpcr.2018.v11i2.22516]
Dastjerdi AG, Akhgari M, Kamali A, Mousavi Z. Principal component analysis of synthetic adulterants in herbal supplements advertised as weight loss drugs. Complementary Therapies in Clinical Practice. 2018; 31:236-41. [DOI:10.1016/j.ctcp.2018.03.007] [PMID]
Görög S. Identification in drug quality control and drug research. TrAC Trends in Analytical Chemistry. 2015; 69:114-22. [DOI:10.1016/j.trac.2014.11.020]
Zhang J, Wider B, Shang H, Li X, Ernst E. Quality of herbal medicines: Challenges and solutions. Complementary Therapies in Medicine. 2012; 20(1-2):100-6. [DOI:10.1016/j.ctim.2011.09.004] [PMID]
World Health Organization (WHO). Guidelines for the appropriate use of herbal medicines. Geneva: World Health Organization; 1998. [Link]
Margine I, Martinez-Gil L, Chou YY, Krammer F. Residual baculovirus in insect cell-derived influenza virus-like particle preparations enhances immunogenicity. Plos One. 2012; 7(12):e51559. [DOI:10.1371/journal.pone.0051559] [PMID] [PMCID]
World Health Organization (WHO). WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems [Internet]. 2004 [Updated 2004 June 5]. Available from: [Link]
Calapai G. European legislation on herbal medicines: A look into the future. Drug Safety. 2008; 31(5):428-31. [DOI:10.2165/00002018-200831050-00009] [PMID]
Mortazavi SMJ, Moharrami A, Shafiei H, Ebrahimzadeh MH, Karimi M. Unapproved weight gain supplement as a cause of avascular necrosis: A cautionary report. The Archives of Bone and Joint Surgery. 2019; 7(6):561-5. [PMID] [PMCID]
Saberi N, Akhgari M, Bahmanabadi L, Bazmi E, Mousavi Z. Determination of synthetic pharmaceutical adulterants in herbal weight gain supplements sold in herb shops, Tehran, Iran. Daru. 2018; 26(2):117-27. [DOI:10.1007/s40199-018-0216-2] [PMID] [PMCID]
Bogusz MJ, al Tufail M, Hassan H. How natural are 'natural herbal remedies'? A Saudi perspective. Adverse Drug Reactions and Toxicological Reviews. 2002; 21(4):219-29. [DOI:10.1007/BF03256198] [PMID]
Coghlan ML, Maker G, Crighton E, Haile J, Murray DC, White NE, et al. Combined DNA, toxicological and heavy metal analyses provides an auditing toolkit to improve pharmacovigilance of traditional Chinese medicine (TCM). Scientific Reports. 2015; 5:17475. [DOI:10.1038/srep17475] [PMID] [PMCID]
Leslie WS, Hankey CR, Lean ME. Weight gain as an adverse effect of some commonly prescribed drugs: A systematic review. QJM. 2007; 100(7):395-404. [DOI:10.1093/qjmed/hcm044] [PMID]
Harrison ME, Norris ML, Robinson A, Spettigue W, Morrissey M, Isserlin L. Use of cyproheptadine to stimulate appetite and body weight gain: A systematic review. Appetite. 2019; 137:62-72. [DOI:10.1016/j.appet.2019.02.012] [PMID]
Couluris M, Mayer JL, Freyer DR, Sandler E, Xu P, Krischer JP. The effect of cyproheptadine hydrochloride (periactin) and megestrol acetate (megace) on weight in children with cancer/treatment-related cachexia. Journal of Pediatric Hematology/Oncology. 2008; 30(11):791-7. [DOI:10.1097/MPH.0b013e3181864a5e] [PMID] [PMCID]
Sant'Anna AM, Hammes PS, Porporino M, Martel C, Zygmuntowicz C, Ramsay M. Use of cyproheptadine in young children with feeding difficulties and poor growth in a pediatric feeding program. Journal of Pediatric Gastroenterology and Nutrition. 2014; 59(5):674-8. [DOI:10.1097/MPG.0000000000000467] [PMID]
American Society of Health-System Pharmacists. AHFS drug information. Bethesda: American Society of Health-System Pharmacists; 2000. [Link]
Moffat AC, Osselton MD, Widdop B, Watts J. Clarke’s analysis of drugs and poisons. London: Pharmaceutical Press; 2011. [Link]
Graudins A, Stearman A, Chan B. Treatment of the serotonin syndrome with cyproheptadine. The Journal of Emergency Medicine. 1998; 16(4):615-9. [DOI:10.1016/S0736-4679(98)00057-2] [PMID]
Vikram Kumar V, Rama Devi K. Acute cyproheptadine poisoning. Indian Journal of Pediatrics. 1989; 56(4):521-3. [DOI:10.1007/BF02722431] [PMID]
Levine B, Green-Johnson D, Hogan S, Smialek JE. A cyproheptadine fatality. Journal of Analytical Toxicology. 1998; 22(1):72-4. [DOI:10.1093/jat/22.1.72] [PMID]
- Abstract Viewed: 359 times
- pdf Downloaded: 208 times