Online ED drug purchases pose health risks, Korean study shows

Erectile dysfunction (ED) drugs purchased online may be worse than useless. They could pose significant health risks.

That was the key message from a recent study of ED drugs purchased online and analyzed for their actual content. The data were presented at the 105th Annual Scientific Meeting of the American Urological Association earlier this year.

“A lot of patients order their drugs online these days, even when they have seen a physician and have a prescription,” said Kewon Min, MD, Busan Paik Hospital, Busan, Korea. “They think they can get quality ED drugs at good prices, but our results show that there can be major risks. ”

The risks, he said, include toxic levels of heavy metals, including mercury, lead, cadmium, arsenic, and chrome, as well as nonmetallic toxins, including polychlorinated biphenyls and benzopyrenes. The online samples also contained a wide variety of unapproved erectogenic ingredients such as homosildenafil, hongdenafil, aminotadalifil, xanthoanthrafil, pseudovardenafil, and more.

“What we know is that these counterfeit products are made under dirty, uncontrolled conditions,” Dr. Min said. “Side effects from drug products purchased online, including death, have been documented worldwide.”

That’s no surprise to the Partnership for Safe Medicines (www.safemedicines.org), which maintains an encyclopedia of counterfeit drug incidents. The listings range from recent seizures of counterfeit antibiotics, antimalarials, and ED products in Thailand to counterfeit heparin deaths in the United States, fake insulin pen needles in the United Kingdom, and infant deaths from counterfeit teething syrup in Nigeria. Partnership members include the American Pharmacists Association (APhA), the American Society of Health-System Pharmacists (ASHP), the National Association of Boards of Pharmacy (NABP), and several state pharmacy associations.

“Patients are putting their health at risk when they go outside the normal chain of custody to purchase medications,” Kristina Lunner, APhA vice president, government affairs, told Drug Topics. “Sidestepping the regulatory system by purchasing from an illegitimate drug seller (not to be confused with a legitimate Internet pharmacy) removes two critical elements from the drug distribution system.

“First, it removes prescribers and pharmacists, who by law are required to ensure that the patient is getting the right medication at the right time. Second, it removes the regulations for manufacturers and distributors that work to ensure the integrity of the product. Removing these elements removes any assurance that the patient will get the benefit of the medication and will not be harmed by it.”

Online sales of ED products have soared since the approval of Viagra (sildenafil, Pfizer), Dr. Min said. Anecdotal reports suggested there were safety problems with at least some ED products purchased.

“We couldn‘t find good reports in the literature of what might be in these products,” he said. “So we conducted our own analysis.”

Researchers purchased 19 lots of Viagra and Cialis (tadalafil, Lilly) online and in illicit retail settings. Only one of the 19 samples contained the correct amount of the labeled active ingredient, while 58% contained up to 2.4 times the labeled dose and 37% had no active ingredient at all. A total of 10 unapproved erectogenic materials were identified in the samples, and 26% were contaminated with heavy metals and other toxins.

Dr. Min said the results were not unexpected. The World Health Organization estimates that more than half of drug products sold online are counterfeit, compared to 1% to 4% of prescription drugs sold through licensed pharmacies in developed countries. With the exception of drugs in developed markets such as Japan and Korea, more than 30% of the drug supply in Africa and Asia is counterfeit. Most illicit drugs sold online in the Asia-Pacific region are made in China, Dr. Min said, while online counterfeits destined for Europe and the United States tend to be made in India or the Middle East.

“Anything you buy from the Internet could be counterfeit,” Dr. Min said. “You just can’t know your source when you buy online.”