title: Sildenafil and analogous phosphodiesterase type 5 (PDE-5) inhibitors in herbal food supplements sampled on the Dutch market.
abstract: Herbal food supplements, claiming to enhance sexual potency, may contain deliberately added active pharmacological ingredients (APIs) that can be used for the treatment of erectile dysfunction (ED). The aim of this study was to determine whether herbal food supplements on the Dutch market indeed contain APIs that inhibit phosphodiesterase type 5 (PDE-5) inhibitors, such as sildenafil and analogous PDE-5 inhibitors. Herbal food supplements intended to enhance sexual potency (n = 71), and two soft drinks, were sampled from 2003 up to and including 2012. In 23 herbal supplements, nine different PDE-5 inhibitors were identified; in a few cases (n = 3), more than one inhibitor was indentified. The presence of these APIs was however not stated on the label. The concentrations of PDE-5 inhibitors per dose unit were analysed. Furthermore, the potential pharmacologically active properties of the detected PDE-5 inhibitors were estimated by using data from the scientific and patent literature regarding (1) in vitro PDE-5 activity, (2) reported effective doses of registered drugs with PDE-5 inhibitor activity and (3) similarity to other structural analogues. It was concluded that 18 of the 23 herbal food supplements, when used as recommended, would have significant pharmacological effects due to added APIs. Adequate use of existing regulation and control measures seems necessary to protect consumers against the adverse effects of these products.
authors.affiliation: a Netherlands Food and Consumer Product Safety Authority (NVWA) , Office for Risk Assessment and Research , Utrecht , The Netherlands.
authors.forename: N M
authors.initials: NM
authors.lastname: Reeuwijk
authors.forename: B J
authors.initials: BJ
authors.lastname: Venhuis
authors.forename: D
authors.initials: D
authors.lastname: de Kaste
authors.forename: L A P
authors.initials: LA
authors.lastname: Hoogenboom
authors.forename: I M C M
authors.initials: IM
authors.lastname: Rietjens
authors.forename: M J
authors.initials: MJ
authors.lastname: Martena
mesh_terms: D002253:Carbonated Beverages / Q000009:adverse effects / Q000032:analysis / Q000191:economics; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D019587:Dietary Supplements / Q000009:adverse effects / Q000032:analysis* / Q000191:economics; D007172:Erectile Dysfunction / Q000178:diet therapy / Q000188:drug therapy; D005506:Food Contamination / Q000331:legislation & jurisprudence; D005515:Food Labeling; D019983:Guideline Adherence; D006801:Humans; D020407:Internet; D007880:Legislation, Drug; D007881:Legislation, Food; D008297:Male; D009426:Netherlands; D058573:Performance-Enhancing Substances / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage / Q000032:analysis* / Q000494:pharmacology / Q000627:therapeutic use; D010879:Piperazines / Q000008:administration & dosage / Q000032:analysis* / Q000494:pharmacology / Q000627:therapeutic use; D010946:Plants, Medicinal; D062486:Public Health Surveillance; D011687:Purines / Q000008:administration & dosage / Q000032:analysis / Q000494:pharmacology / Q000627:therapeutic use; D012725:Sexual Behavior / Q000187:drug effects; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000008:administration & dosage / Q000032:analysis* / Q000494:pharmacology / Q000627:therapeutic use; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000032:analysis* / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D058573:Performance-Enhancing Substances; D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; C520604:aildenafil; D000068677:Sildenafil Citrate