[Drug counterfeiting--the risk to the public health].
Pharmaceutical counterfeiting and purchasing medicines from illegal distribution channels have become more and more common problem in our country. Different medicines, especially erectile dysfunction drugs are involved. The aim of this study was the qualitative analysis of fake Levitra tablets and the estimation of the risk they bear to potential users. Tablets were secured by the police and delivered to Bayer office in 2006.


RESULTS
Trace amount of sildenafil (the active ingredient of Viagra) and not vardenafil (the active ingredient of Levitra) was found in tablets described as "Levitra" (vardenafil). The presence of this substance was discovered by NIR--and Raman spectroscopy. The appearance of tablets and blisters corresponded to the original product. There were no paper boxes and patient information leaflets attached. As prescription medicines erectile dysfunction drugs should be purchased from a pharmacy only. They need to be used under strict medical control.
Tajanko
Elzbieta
E
Dział Medyczny, Bayer Sp. z o.o. elzbieta.tajanko.et@bayer-ag.de
Sein Anand
Jacek
J
Roszkowska-Kranc
Katarzyna
K
Kozłowska-Boszko
Beata
B
Chodorowski
Zygmunt
Z
Korolkiewicz
Roman Paweł
RP
D002243:Carbolines / Q000032:analysis; D004339:Drug Compounding; D004340:Drug Contamination / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000592:standards; D004349:Drug Packaging / Q000592:standards; D007172:Erectile Dysfunction / Q000188:drug therapy*; D005607:Fraud / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D006801:Humans; D007093:Imidazoles / Q000032:analysis; D007880:Legislation, Drug / Q000592:standards; D008297:Male; D010726:Phosphodiesterase Inhibitors / Q000737:chemistry / Q000592:standards* / Q000600:supply & distribution* / Q000627:therapeutic use; D010879:Piperazines / Q000032:analysis; D011044:Poland; D011634:Public Health / Q000706:statistics & numerical data; D011687:Purines / Q000032:analysis; D011786:Quality Control; D018570:Risk Assessment / Q000706:statistics & numerical data; D000068677:Sildenafil Citrate; D013059:Spectrum Analysis, Raman; D013450:Sulfones / Q000032:analysis; D000068581:Tadalafil; D014227:Triazines / Q000032:analysis; D000069058:Vardenafil Dihydrochloride
D002243:Carbolines; D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride; D000068581:Tadalafil; D000068677:Sildenafil Citrate