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Drug manufacturing

EMA tells drug manufacturers to test for probable carcinogen

The European Medicines Agency (EMA) has told drug manufacturers to test all medicines that contain chemically synthesised active substances to test for the presence of nitrosamines.

The EMA’s human medicines committee said in a press release on 26 September 2019 that it was requesting marketing authorisation holders for human medicines to “test all products at risk … as a matter of precaution”.

If nitrosamines are detected in any of their medicines, manufacturers must inform authorities promptly, the EMA said. A notice has been sent to drug manufacturers providing information on risk evaluation, confirmatory testing, and any changes they may need to request to the marketing authorisation.

Nitrosamines are classified as probable carcinogens, although the EMA said that when they have been found in medicines the risk of developing cancer has been low.

In 2018, nitrosamines and another probable carcinogen, N-nitrosodimethylamine (NDMA), were found in several sartan blood pressure medicines, leading to recalls and an EU review which set strict new manufacturing requirements for these medicines.

Then, in September 2019, the EMA announced that it was beginning a review of ranitidine medicines after tests revealed the presence of NDMA.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20207136

Readers' comments (1)

  • Nitrosamines (or their precursor) are reputedly present in nitrate/nitrite cured meats. Perhaps they'll be made illegal soon.

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