Dirty drugs again

What is going on?

Daily newspaper NRC and TV show zembla Chinese batches have had the raw material for paracetamol examined in a German laboratory. The batches tested were found to be contaminated with the carcinogenic substance PCA. The raw material accounted for a total of 36 million tablets, which were produced this spring. The raw material came from the Chinese factory Anqui Lu’an, the largest producer of paracetamol raw material in the world.

Is my paracetamol contaminated?

It is not known exactly where the paracetamol was sold. Unfortunately, you cannot check your medicine cabinet to see if your paracetamol is ‘clean’. It is suspected that producer Apotex buys from this Chinese factory. Apotex makes paracetamol tablets for private labels of Albert Heijn, Etos, Jumbo, Trekpleister, DA and Kruidvat. The Medicines Evaluation Board is aware of the situation, but does not release this information. Here have MPs objected to. The lecture write in a comment that she is going to check whether the paracetamol has entered the Dutch market.

How dangerous is this pollution?

The pollutant PCA, in full 4-chloroaniline, was created when the raw material for the paracetamol was made. This substance is carcinogenic and possibly also harmful to DNA, according to NRC. So a dangerous substance, but whether a substance is really toxic to your body also depends on the amount and duration that you are exposed to it. For this type of substances, maximum limits have therefore been agreed at European level.

It turns out that this contaminated paracetamol does meet the maximum standard for medicines of the European Medicines Authority EMA, but not the maximum standard for food (of the EFSA). You eat much more from food than from pills, hence this difference in standard. So it is allowed, but it makes toxicologists frown, according to the tour of NRC and Zembla. ‘PCA does not belong in a painkiller that so many people take’, says Leuven toxicologist Jan Tytgat, for example. He believes that this contaminated paracetamol should be removed from the market.

Will the batches be withdrawn from the market?

Getting all paracetamol directly off the market is still a bridge too far. The risks of the contaminated paracetamol are small and the alternative means (NSAIDs such as ibuprofen and naproxen) have more side effects. But research is being conducted at the request of Minister Tamara van Ark. The College: ‘This limit is based on a negligible risk: one extra person developing cancer for every 100,000 people who take 6 tablets of 500 mg paracetamol daily for life. With short-term use, the risk is many times lower.’

Can I opt for cleaner medicines?

Unfortunately, as a consumer you do not know where the raw materials from your medicines come from. It’s nowhere on the box and it’s nowhere to be found. We do know that most raw materials nowadays come from China and India. Countries where raw materials are often offered very cheaply, which may be the cause of the contamination in medicines. Because it is not the first time that medicines on the Dutch market have been contaminated. Previously, high blood pressure drugs such as valsartan were contaminated. Stomach protectors such as ranitidine were also contaminated. In this video chairman Ton de Boer answered questions about the contaminated stomach acid inhibitors.

UPDATE: The pharmacists want to know if there is contaminated paracetamol on the shelves. They are going to investigate the paracetamol themselves, according to NRC. Chairman of the KNMP pharmacists’ organization Aris Prins: ‘We have a huge population of paracetamol users worldwide. If further research can lead to better standards for cheaper production methods, we will certainly support it.’