Men who buy fake internet drugs for erection problems can face significant risks from potentially hazardous contents and bypassing healthcare systems could leave associated problems like diabetes and high blood pressure undiagnosed. That’s the warning just published online by IJCP, the International Journal of Clinical Practice.

Medical and pharmaceutical experts from the UK, Sweden and USA carried out a detailed review of the growing problem of counterfeit drugs. Estimates suggest that up to 90 per cent of these illegal preparations are now sold on the internet.

The review, which covers more than fifty studies published between 1995 and 2009, provides a valuable overview of the scale of counterfeit internet drugs, with a specific focus on erectile dysfunction (ED) drugs.

These have played a key role in driving the growth of counterfeit drugs, with studies suggesting that as many as 2.3 million ED drugs are sold a month, mostly without prescription, and that 44 per cent of the Viagra offered on the internet is counterfeit.

“The presence of unknown pharmaceutically active ingredients and/or impurities may lead to undesirable and serious adverse events, even death” warns lead author and journal editor Graham Jackson, a London-based cardiologist.

“We discovered that 150 patients had been admitted to hospitals in Singapore after taking counterfeit tadalfil and herbal preparations that claimed to cure ED. Seven were comatose, as the drugs contained a powerful drug used to treat diabetes, and four subsequently died.”

But it’s not just erectile dysfunction drugs that pose a risk, as Dr Jackson points out: “In Argentina, two pregnant women died after being given injections of a counterfeit iron preparation for anaemia and 51 children died in Bangladesh of kidney failure after taking paracetamol syrup contaminated with diethylene glycol, which is widely used as car antifreeze.”

Other examples include fake contraceptive and antimalaria pills, counterfeit antibiotics and a vaccine for life-threatening meningitis that only contained water.

The US-based Center for Medicine in the Public Interest estimates that the global sale of counterfeit drugs will reach $75 billion in 2010, a 92 per cent increase in five years.

Counterfeit seizures in the European Union (EU) quadrupled between 2005 and 2007 and the number of drug fraud investigations carried out by the US Food and Drug Administration rose 800 per cent between 2000 and 2006.

ED drugs are the most commonly counterfeited product seized in the EU due to their high cost and the embarrassment associated with the underlying condition. Some estimates suggest that as many as 2.5 million men in the EU are using counterfeit Viagra.

Analysis of counterfeit ED drugs has shown that some contain active ingredients, while others contain potentially hazardous contaminants.

Pfizer, which manufactures Viagra, analysed 2,383 suspected counterfeit samples forwarded to the company by law enforcement agencies between 2005 and 2009. It found that that a Hungarian sample contained amphetamine, a UK sample contained caffeine and bulk lactose and that printer ink had been used to colour some samples blue. Other samples contained metronidazole, which can have significant adverse effects when combined with alcohol.”

And a study of 370 seized “Viagra” samples carried out by the Dutch National Institute for Public Health found that only 10 were genuine, with a range of other drugs present in the samples.

“As well as the risk posed by unknown ingredients, internet drugs circumvent traditional healthcare and this poses its own risks as underlying health conditions could go undiagnosed if people don’t seek medical advice” says Dr Jackson.

The World Health Organization states that counterfeit medicines are a threat to communities and must be stopped and there is a general consensus that steps need to be taken to tackle the problem.

“However, obstacles to effective action include the lack of a clear worldwide consensus on what constitutes a counterfeit drug and the fact that activities that are illegal in one country may be legal in another” says Dr Jackson.

“In some cases producing counterfeit medicine can be ten times as profitable per kilogram as heroin, yet in the UK someone can face greater legal sanctions if they produce a counterfeit T-shirt.

“What is clear is that we need much greater public awareness of the risks of buying counterfeit drugs, as lives are at risk.

“It is essential that healthcare clinicians get that message across.”

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The article can be accessed free at: http://www3.interscience.wiley.com/cgi-bin/fulltext/123243854/PDFSTART

Notes to editors

Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. Jackson et al. IJCP. Article published online in advance of print. (January 2010). 10.1111/j.1742-1241.2009.02328.x

IJCP, the International Journal of Clinical Practice was established in 1946 and is edited by Dr Graham Jackson. It provides its global audience of clinicians with high-calibre clinical papers, including original data from clinical investigations, evidence-based analysis and discussions on the latest clinical topics. The journal is published by Blackwell Publishing Ltd, part of the international Blackwell Publishing group. http://www.ijcp.org http://www.twitter.com/IJCPeditors

Wiley-Blackwell is the international scientific, technical, medical and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world’s leading societies. Wiley-Blackwell publishes over 1,400 peer-reviewed journals as well as 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols.

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