Keywords
sildenafil
tadalafil
aristolochic acid
adulteration
aphrodisiacs
Kinshasa
Kisangani
PDE 5
pharmaceutical fraud
How to Cite
Abstract
Introduction
This study aims to identify the presence of undeclared active ingredients in aphrodisiac products sold as teas and coffees in Kinshasa and Kisangani (DRC). Sexual dysfunction is widespread, and many individuals in the Democratic Republic of the Congo rely on aphrodisiac teas and coffees. However, their unregulated nature raises concerns about adulteration with undeclared substances (sildenafil and tadalafil) and potentially harmful compounds (aristolochic acid), posing significant health risks.
Purpose
To detect, by HPLC, the presence of PDE‑5 inhibitors (sildenafil, tadalafil) and toxic compounds (aristolochic acid) in aphrodisiac products marketed without regulation.
Methods
Nine samples, including seven from Kinshasa and two from Kisangani, were analysed by HPLC after sample‑preparation protocols adapted from validated studies.
Results
Sildenafil was detected in 9/9 products and tadalafil in 8/9; traces of aristolochic acid were identified in two products. Quantitative variation suggests deliberate adulteration.
Conclusion
These products contain undeclared and potentially harmful substances, posing a significant health risk such as cardiovascular complications, drug interactions, and possible carcinogenic effects, underscoring the urgent need for stricter regulation.
References
Arlt, V. M., Stiborova, M., & Schmeiser, H. H. (2011). Aristolochic acid as a probable human cancer hazard in herbal remedies: A review. International Journal of Cancer, 128(1), 17–31. https://doi.org/10.1002/ijc.25356
Baume, N., Mahler, N., Kamber, M., Mangin, P., & Saugy, M. (2006). Use of undeclared substances in dietary supplements. British Journal of Clinical Pharmacology, 61(5), 614–618. https://doi.org/10.1111/j.1365-2125.2006.02652.x
Benamar, H., & Amine, A. (2019). Analytical study of aphrodisiac supplements in Morocco [in French]. Revue Marocaine de Toxicologie, 5(2), 77–84.
Chen, Y., Yu, L., Zhang, Q., & Shi, J. (2013). Adulteration of herbal sexual enhancement supplements with synthetic PDE5 inhibitors. JAMA Internal Medicine, 173(10), 829–832. https://doi.org/10.1001/jamainternmed.2013.613
Debelle, F. D., Vanherweghem, J. L., & Nortier, J. L. (2008). Mechanisms of aristolochic acid toxicity and carcinogenicity. Drug Metabolism Reviews, 40(2), 335–375. https://doi.org/10.1080/03602530801916774
De la Torre, R., Segura, J., Ventura, R., & Pozo, O. J. (2020). Illicit use of phosphodiesterase type 5 inhibitors and analogues in dietary supplements. Drug Testing and Analysis, 12(2), 229–241. https://doi.org/10.1002/dta.2726
Eli Lilly and Company. (2020). Cialis® (tadalafil) product information. https://www.cialis.com/
Food and Drug Administration (FDA). (2020). Tainted sexual enhancement products. U.S. Food & Drug Administration. https://www.fda.gov
Grollman, A. P., & Shibutani, S. (2010). Aristolochic acid nephropathy: A global disease. Kidney International, 78(6), 517–523. https://doi.org/10.1038/ki.2010.241
International Agency for Research on Cancer (IARC). (2002). Aristolochic acids. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, 82, 301–366.
Kagoya, H. R., Mwesige, F. A., & Luyiga, H. (2022). Quality of herbal aphrodisiacs in Uganda: A public health concern. African Health Sciences, 22(3), 189–196. https://doi.org/10.4314/ahs.v22i3.20
Kayembe, K. P., Kalonda, M. E., & Kizungu, B. M. (2014). Availability and use of traditional herbal medicines in Kinshasa: A cross-sectional survey. African Journal of Traditional, Complementary and Alternative Medicines, 11(3), 123–130. https://doi.org/10.4314/ajtcam.v11i3.17
Kaufman, D. W., Kelly, J. P., Rosenberg, L., Anderson, T. E., & Mitchell, A. A. (2003). Recent patterns of medication use in the ambulatory adult population of the United States. JAMA, 287(3), 337–344. https://doi.org/10.1001/jama.287.3.337
Mukonzo, J. K., Waako, P., & Nambasa, V. (2021). Herbal medicines in primary healthcare in sub-Saharan Africa: Practices, perceptions, and regulatory challenges. Journal of Ethnopharmacology, 278, 114302. https://doi.org/10.1016/j.jep.2021.114302
Pawar, R. S., & Grundel, E. (2017). Analytical challenges in detecting adulterants in herbal supplements. Clinical Pharmacology & Therapeutics, 101(3), 333–342. https://doi.org/10.1002/cpt.611
Pfizer Inc. (2020). Viagra® (sildenafil) prescribing information. https://www.viagra.com/
United Nations, Department of Economic and Social Affairs, Population Division. (2022). World Urbanization Prospects 2022: The 10 largest urban agglomerations. United Nations. https://population.un.org/wup/
Vaclavik, L., Krynitsky, A. J., & Rader, J. I. (2014). Quantification of active pharmaceutical ingredients in adulterated dietary supplements using HPLC-MS. Journal of Pharmaceutical and Biomedical Analysis, 88, 295–305. https://doi.org/10.1016/j.jpba.2013.09.008
World Health Organization (WHO). (2017). WHO guidelines for the quality control of herbal medicines. WHO Press. https://apps.who.int/iris/handle/10665/44409
World Health Organization (WHO). (2019). Substandard and falsified medical products. WHO Press. https://www.who.int/publications/i/item/9789241513425
World Health Organization Regional Office for Africa (WHO-AFRO). (2020). Regulatory framework for traditional and complementary medicine products in Africa. WHO-AFRO. https://www.afro.who.int
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