The world's largest producer of the active pharmaceutical ingredient in paracetamol has sold batches contaminated with a cancer-causing substance, Dutch newspaper NRC and the documentary programme Zembla found.
Anqiu Lu’an Pharmaceutical, the Chinese company in question, “has supplied the raw material used in much of the paracetamol sold in chemists, supermarkets and pharmacies throughout the Netherlands,” according to NRC.
“The odds are high that they were also sold in our country,” Belgian toxicologist Jan Tytgat of the University of Leuven (KU Leuven) told Het Laatste Nieuws. “One has to trace those contaminated painkillers and take them off the market.”
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Samples from three batches of the active ingredient were sent to a laboratory in Germany, which found that they were all contaminated with 4-chloroaniline, or PCA. The substance is formed when producing paracetamol and is a genotoxic carcinogen, according to the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA). This means it can damage genetic information and thus cause cancer.
Someone taking over six tablets would exceed the EMA’s guidelines for tolerable daily intake, while EFSA considers that taking more than one contaminated tablet per day “may already lead to an unacceptable risk of cancer,” NRC said.
“Above this margin, there is a substantiated risk that PCA is carcinogenic,” said Tytgat, referring to the EFSA norm. “PCA does not belong in a painkiller that is used by so many people,” he added.
Tytgat was of the opinion that batches of the active ingredient from factories using the same production methods should also be tested, as was Emeritus Professor of Toxicology at Utrecht University, Martin van den Berg.
As a result of the discovery, Federal MP Kathleen Depoorter has called on Health Minister Maggie De Block to investigate the presence of possible carcinogenic paracetamol in Belgium.
“Paracetamol is a medicine that almost everyone takes, we cannot afford to take a single risk,” Depoorter said. The Federal Agency for Medicines and Health Products believes that nine medicines in Belgium could be concerned, according to Het Belang van Limburg.
Jason Spinks
The Brussels Times
