Translation of a-t 2020; 51: 54-5
 

IN BRIEF

Carcinogen detected in paracetamol

There have been reports from the Netherlands of impurities in the analgesic paracetamol in the form of para-chloroaniline (PCA; 4-chloroaniline) (1,2), which is classed as a genotoxic carcinogen (3). A German laboratory carrying out contract analyses identified PCA in all three of the batches tested which contained active substance produced by the Chinese manufacturer Anqiu Lu'an, the largest paracetamol producer in the world. There was, however, no specific information about the quantities contained. The European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) rate the risks of contamination with the genotoxic carcinogen differently, with the EFSA, which has residue in food in mind, obviously setting stricter standards (1,4). The batches containing the PCA would be sufficient for around 36 million tablets (1). The commercial preparations in which those batches were processed have yet to be identified. It is also necessary to clarify which paracetamol producers use the same manufacturing process as Anqiu Lu'an and whether or which preparations need to be withdrawn because of contamination. It should be clear that PCA absolutely does not belong in medicinal products, -Ed.

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