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Once again, children are the main victims of fake drugs
  1. Maurizio Bonati
  1. M Bonati

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Within a fortnight in November 2008, 34 Nigerian children, aged 4 months to 3 years, died and more than 50 others were hospitalised with severe kidney damage after taking the drug “My Pikin” (“my child” in local pidgin), a teething mixture containing paracetamol.1 The outbreak was due to the use of diethylene glycol (DEG)2 as a solvent for the paracetamol. DEG was present because of inadvertent or deliberate substitution of propylene glycol, which is much less toxic than DEG and is widely used in the pharmaceutical industry.3 DEG is a colourless and odourless liquid, commonly used in industry, and can be found in commercial products such as resins, antifreeze, inks and glues.4 It is a well-known human toxicant that causes generalised multi-organ failure characterised by acute renal failure (oliguria or anuria) frequently accompanied by severe neurological dysfunction (cranial nerve palsies, acute flaccid extremity weakness and encephalopathy).5 Documented deaths are only the tip of the iceberg, because, in these cases, the extensive kidney tubule necrosis caused by DEG evolves rapidly, leading to anuria and death within a few days. In developing countries where many patients are unable to access healthcare, the size of each outbreak may be much larger.

Evidence of DEG toxicity has been available since 1937 when the first and largest outbreak, which resulted in 105 deaths (34 children and 71 adults), occurred in the USA in users of a sulphanilamide elixir (the first sulfa antimicrobial drug) containing DEG.6 However, since that time, there have been many other DEG mass poisonings, especially affecting children in developing countries. Paediatric syrups contaminated with DEG led to the death of 7 children in South Africa in 1969,7 47 children in Nigeria in 1992,8 51 children in Bangladesh in 1995,9 85 children in Haiti10 and 33 children in India in 1998.11 Unfortunately, this tragedy has once again been repeated, and for the second time in Nigeria.

Acute renal failure is an unusual cause of death among children. Thus, when an outbreak occurs, there are two main possibilities: infection or poisoning. Bacterial cultures and viral tests can confirm an infection, whereas chemical analyses of both biological samples and suspected products are needed to identify the toxic substance. Unfortunately, in developing countries the availability of chemical and biological diagnostic tests is limited. Additionally, the only effective renal management of DEG poisoning is haemodialysis or peritoneal dialysis. Thus, these tragedies affect the health rights of people living in impoverished countries and, in particular, children.

Drug regulatory agencies determine which excipients are acceptable and usually set exposure limits and labelling requirements for the finished products. The calamities related to DEG-adulterated medicines highlight that in developing countries adequate registration, enforcement, or strict implementation of good drug manufacturing practice regulations is scant. The technology to apply international standards of pharmacopoeia are not worldwide available or too costly to use, even if a few initiatives aimed at preventing or limiting such repeating tragedies were attempted by the World Health Organization (WHO).10

Medicines manufactured below established standards of quality are part of the broader phenomenon of counterfeit drugs.12 Counterfeiting medicines is a hugely lucrative business and a global public health challenge. In many countries of the south, 10–30% of the medicines on sale can be counterfeit. It has been estimated that 70% of drugs in Nigeria are either fake or adulterated, and these involve both locally produced and imported drugs. For a country like Nigeria that hopes to become one of the 20 largest economies in the world by 2020,13 efforts are needed both in improving the production, trading, and selling of medicines, and enforcing pharmaceutical legislation. In 2006, WHO created the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT) that comprises all 193 WHO member states and includes international and non-governmental organisations, enforcement agencies, national drug regulatory authorities, customs and police organisations, associations representing pharmaceutical manufacturers and wholesalers, health professionals and patients’ groups.14 However, patients and parents in extremely poor areas are neither informed about the risks of counterfeits nor aware of their rights to have safe medicines.

The availability of licensed formulations of medicines specifically designed for children is far from optimal worldwide,15 16 but the DEG killer-saga17 underlines that children are the major victims and one of the “markers” of existing health inequalities in the world.

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Footnotes

  • Competing interests: None.

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