The European Medicines Agency (EMA)'s review of the contamination of sartan-containing anti-hypertensives has released estimates of the associated cancer risk.
The review has concluded that if 100,000 patients took valsartan products with the highest levels of N-nitrosodimethylamine (NDMA) every day for six years, there could be 22 extra cases of cancer over a lifetime. N‑nitrosodiethylamine (NDEA) in these medicines could lead to eight extra cases in 100,000 patients taking the highest dose every day for four years.
The estimates have been extrapolated from animal studies. The six and four years refer to the duration of time NDMA and NDEA are believed to have been present in the products.
In an update on the review, the EMA said that for the vast majority of sartan medicines, impurities were either not found or were present at very low levels.
Manufacturers of sartan-containing anti-hypertensives have been given a deadline of two years to demonstrate that their sartan products have no quantifiable levels of these impurities before they can be used in the European Union. In the meantime, strict temporary limits will apply. The limits are based on the maximum daily intake for each impurity derived from animal studies.