Pharmaceutical Drugs are Subject to Strict Regulation in Most Countries

This one-hundred-and-eighth volume of the IARC Monographs includes evaluations of the carcinogenic hazard to humans of exposure to 14 herbal products or pharmaceutical drugs. None of these, except hydrochlorothiazide, have been previously evaluated by the Working Group.

Hydrochlorothiazide – a pharmaceutical drug – was considered in 1989 by an IARC Monographs Working Group (IARC, 1990), and was evaluated as not classifiable as to its carcinogenicity to humans (Group 3) based on inadequate evidence for carcinogenicity in humans and in experimental animals.

 

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A summary of the findings of this meeting appears in The Lancet Oncology 

Several pharmaceuticals and other drugs

Among the agents that are known to cause cancer in humans specifically, there are several pharmaceuticals and other drugs. Volume 100A of the IARC Monographs (IARC, 2012) reviewed pharmaceuticals that in previous evaluations had been categorized as carcinogenic to humans (Group 1), primarily on the basis of epidemiological evidence for causation. In respect of specific chemical carcinogens, the number of agents classified as carcinogenic to humans that are therapeutic drugs is second only to the number of agents that have been identified in the context of occupational exposures.

Apart from pharmaceutical drugs that are industrially produced agents identified with a specific therapeutic usage, a major aspect of the use of drugs worldwide involves herbal products. Estimates from WHO indicate that 80% of the world’s population has used herbal products as medicines. Use of the term “herbal medicine” is arbitrary in many contexts. In particular, a wide variety of pharmaceutical drugs, that is, agents recognized as having a particular pharmacological mode of action and associated clinical benefit, are derived from plants or other natural sources. This category of agent is likewise represented in previous IARC Monographs; and one – aristolochic acid – has been classified as a Group 1 agent (IARC, 2012).

 

Preparation of herbal medicines

 

Pharmaceutical drugs are subject to strict regulation in most countries, and their availability is highly restricted. This may not be the case with materials used in the preparation of herbal medicines. The therapeutic benefit of such herbal products may have been recognized in certain communities for centuries. Moreover, herbal products are available in several regulatory paradigms, ranging from foods and dietary supplements to cosmetics and over-the-counter (non-prescription) and prescription drugs. Worldwide, this means that product quality and composition may vary from country to country and within countries, even when different products bear the same name. In addition, the use of particular herbal products may vary markedly between countries and between communities within a country.