- The European Medicines Agency will ratchet up its investigation of contaminated drug ingredients beyond valsartan, as regulators at the Food and Drug Administration and in Europe continue to investigative the manufacturing of the heart drug.
- The EMA announced Sept. 21 it will expand its review to cover four more APIs: candesartan, irbesartan, losartan and olmesartan.
- The expansion comes after German authorities discovered very low levels of N-nitrosodiethylamine (NDEA) in one batch of losartan API made by Hetero Labs in India.
The valsartan investigative saga continues, now expanding to include other similar APIs.
In June, the FDA found small yet unacceptable levels of N‑nitrosodimethylamine (NDMA) in valsartan active ingredients. Then came the discovery of an additional impurity,N-nitrosodiethylamine (NDEA), in three lots of Torrent Pharmaceuticals' recalled valsartan products which were made from API sourced from Zhejiang Huahai Pharmaceuticals.
While the reason for the impurities remains unclear, it appears tied to the manufacturing process. The sartan molecules include a tetrazole ring structure, and it may be that the synthesis of this leads to the formation of the two impurities.
The low levels of NDEA found are unlikely to carry any risk, according to the EMA. The European regulatory agency advised patients to not stop taking the drugs without speaking to their doctor. Further tests are underway to see how far the contamination goes and whether the levels are above those considered acceptable.
The extension to other sartans is, according to the EMA, precautionary. However, the finding of an impurity in another of the sartan drugs, losartan, suggests that the problem may have broader links across the supply and manufacturing chain.