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Counterfeit Phosphodiesterase Type 5 Inhibitors Pose Significant Safety Risks

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Counterfeit Phosphodiesterase Type 5 Inhibitors Pose Significant Safety Risks REVIEW ARTICLE Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks G. Jackson,1 S. Arver,2 I. Banks,3 V. J. Stecher4 Linked Comment: Jackson. Int J Clin Pract 2010; 64: 413. 1 SUMMARY Cardiac Department, St. Review Criteria Thomas Hospital, London, UK Counterfeit drugs are inherently dangerous and a growing problem; counterfeiters 2 We performed an exhaustive search for articles Andrology Centre, Karolinska are becoming increasingly sophisticated. Growth of the counterfeit medication concerning counterfeit medication using multiple University Hospital, Stockholm, Sweden market is attributable in part to phosphodiesterase type 5 inhibitor (PDE5i) medi- sources, including PubMed, government and 3Men’s Health, Leeds cations for erectile dysfunction (ED). Millions of counterfeit PDE5is are seized yearly organisational websites and legal journals. We Metropolitan University, Leeds, and account for the bulk of all counterfeit pharmaceutical product seizures. It has focused the search on phosphodiesterase type 5 UK been estimated that up to 2.5 million men in Europe are exposed to illicit sildena- inhibitor (PDE5i) medications to provide a 4Global Sexual Health, Pfizer fil, suggesting that there may be as many illegal as legal users of sildenafil. Analy- description of the scope of the problem and the Inc, New York, NY, USA sis of the contents of counterfeit PDE5is shows inconsistent doses of active safety risks associated with counterfeit PDE5i medication. Correspondence to: pharmaceutical ingredients (from 0% to > 200% of labelled dose), contaminants Graham Jackson, MD, London (including talcum powder, commercial paint and printer ink) and alternative ingre- Message for the Clinic Bridge Hospital, 27 Tooley St., dients that are potentially hazardous. In one analysis, only 10.1% of samples were Counterfeit drugs are inherently dangerous and are Suite 301 Emblem House, within 10% of the labelled tablet strength. Estimates place the proportion of coun- a growing problem; industry growth is attributable London SE1 2PR, UK in part to PDE5i medication for erectile dysfunction Tel.: + 44 (207) 407 5887 terfeit medications sold over the Internet from 44% to 90%. Of men who pur- Fax: + 44 (207) 357 7408 (ED). Men often use the Internet to obtain PDE5i chase prescription-only medication for ED without a prescription, 67% do so using Email: [email protected] medication, a practice associated with direct risks the Internet. Counterfeit PDE5is pose direct and indirect risks to health, including (e.g. receiving counterfeit medication) and indirect circumvention of the healthcare system. More than 30% of men reported no Disclosures risks (e.g. circumvention of the healthcare system). Graham Jackson is a consultant healthcare interaction when purchasing ED medications. Because > 65% actually Physicians who treat ED should inform patients of for Lilly and Pfizer, and a had ED, these men missed an opportunity for evaluation of comorbidities (e.g. dia- the dangers of ordering PDE5is via the Internet. meeting participant for Lilly, betes and hypertension). Globally, increased obstacles for counterfeiters are neces- Pfizer, and Bayer. sary to combat pharmaceutical counterfeiting, including fines and penalties. The Stefan Arver has served as a consultant to Pfizer, Eli Lilly, worldwide nature of the counterfeit problem requires proper coordination between Bayer, and has lectured in countries to ensure adequate enforcement. Locally, physicians who treat ED need meetings sponsored by these to inform patients of the dangers of ordering PDE5is via the Internet. corporations. He has received research grants from Bayer. Ian Banks is president of the of counterfeit artesunate, an antimalarial drug, has European Men’s Health Forum; Introduction a consultant ⁄ advisor and been increasing in Southeast Asia. Without the meeting participant ⁄ lecturer for A recent report in the New England Journal of Medi- required active ingredients, patients have died, and Pfizer, Jansen Cilage, GlaxoSmithKline and Celgene. cine chronicled an outbreak of hypoglycaemia in the cause of death was often mistakenly attributed to He is a visiting professor on patients using counterfeit sexual enhancement drugs drug resistance (3). In Bangladesh, at least 51 European Men’s Health at (1). Glyburide, a powerful drug used for the treat- children died in an outbreak of diethylene glycol Leeds Metropolitan University in England, a member of the ment of diabetes, was found to be a contaminant in poisoning of paracetamol syrup, with many more British Medical Association counterfeit tadalafil and herbal preparations for the victims suspected (4). Diethylene glycol contami- Council and the president of treatment of erectile dysfunction (ED) (1). Of the nation of paracetamol syrup was responsible for an Men’s Health Forum England & Wales. 150 non-diabetic patients admitted to hospitals in estimated 192,000 deaths in 2002 (5). Vera Stecher is employed with Singapore, seven patients were comatose as a result Although death is the most extreme consequence Pfizer Inc. of severe neuroglycopenia; four patients subsequently of counterfeit medication, other dangers of counter- died (1). feits are more widespread. Counterfeit drugs may Unpublished research (including This case is just one of many that report the dan- contain excessive or ineffective levels of active ingre- prescription and survey data gers inherent in counterfeit drugs. Other examples dients, contaminants, or inactive or dangerous ingre- and active pharmaceutical ingredient analysis) was include two women in Argentina who died after dients. For example, tap water has been found as the sponsored by Pfizer Inc. being given injections of a counterfeit iron prepara- only ingredient in counterfeit neomycin eye drops Editorial support was provided tion to treat anaemia; another woman survived but and meningococcal vaccine, counterfeit ampicillin by Tiffany Brake, PhD, and Janet Matsuura, PhD, at had a 26-week premature baby (2). The prevalence consisting of turmeric and counterfeit contraceptive ª 2010 Blackwell Publishing Ltd Int J Clin Pract, March 2010, 64, 4, 497–504 doi: 10.1111/j.1742-1241.2009.02328.x 497 498 Counterfeit PDE5i Complete Healthcare pills made of wheat have been reported, and counter- inhibitors [PDE5is, including tadalafil (CialisÒ; Eli Communications, Inc., and was feit antibiotics and snake antivenom (in addition to Lilly and Company, Indianapolis, IN, USA) and var- funded by Pfizer Inc. antimalarials) have been found to lack active ingredi- denafil (LevitraÒ; Bayer HealthCare, Wayne, NJ, Re-use of this article is ents (6). USA)] are the drugs most likely to be counterfeited. permitted in accordance with According to EU counterfeit seizures, PDE5is were the Creative Commons Deed, Attribution 2.5, which does not What is a counterfeit drug and how big is the the most commonly counterfeited class of product in permit commercial exploitation. problem? Europe (15); they are a prime target for counterfeit- The definition of counterfeit drugs varies between ing because of their high cost and the embarrassment countries, but the World Health Organization associated with the underlying condition (14). (WHO) defines counterfeit medicines as those that During the 5 years spanning from 2004 to 2008, ‘are deliberately and fraudulently mislabelled with 35.8 million counterfeit sildenafil tablets were seized respect to identity or source: their quality is unpre- in Europe. In 2004, law officers seized 10.6 million dictable as they may contain the wrong amount of counterfeit sildenafil tablets, which was seven times active ingredients, wrong ingredients or no active the number of all other counterfeited Pfizer products ingredients…[they are] manufactured in clandestine combined (16). In 2006, 2.5 million counterfeit silde- laboratories with no possibility of control (2).’ nafil tablets were seized in the European Union and The prevalence of counterfeit drugs appears to be accounted for 96% of the counterfeit Pfizer products increasing; however, the scale of an illicit industry is seized (16). In 2007, 3.4 million counterfeit sildenafil difficult to determine. Counterfeit seizures in the tablets were seized (16). European Union increased 384% between 2005 and Two different analyses estimated the market size 2006 (7), with a further 51% increase in 2007 (8). for illicit sildenafil (16). From these analyses, it was Customs officials noted that counterfeits were estimated that 0.6–2.5 million men in Europe could becoming more difficult to distinguish from their be exposed to illicit sildenafil. For comparison, IMS genuine counterparts (9). Health (Norwalk, CT) estimates the number of users In the United States, the number of investigations of legal sildenafil in the European Union to be by the Food and Drug Administration (FDA) into 2.5 million in 2006. drug fraud in 2003 was almost four times that in 2000 (10). Additionally, the FDA also noted What is in counterfeit phosphodiesterase type increased complexity and organisation of the coun- 5 inhibitors? terfeit medication industry (10). The FDA has seen At least some active ingredient was present in the an 800% increase in the number of new counterfeit counterfeit Viagra that was seized by the Medical cases between 2000 and 2006 (11). The Center for Control Agency of the United Kingdom (40–100% of Medicine in the Public Interest estimates that the the labelled dosage) (17). A portion (n = 2383) of the global sales of counterfeit drugs will reach $75 billion pharmaceutical agents seized
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