OR WAIT 15 SECS
Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.
The national authorization and supervisory authority for drugs and medical products in Switzerland, Swissmedic, has deemed that medicines currently available on the Swiss market that contain sartans are safe in respect of N-nitrosodimethylamine (NDMA), as revealed in a Nov. 5, 2018 press release.
Swissmedic’s Official Medicines Control Laboratory (OMCL) has been officially testing products containing sartans for potential contamination with NDMA after proprietary medicines were recalled across Europe in July 2018. The contaminated batches had been produced by Chinese manufacturer Zhejiang Huahai Pharmaceutical and was reported to be a result of a change in the synthesis process during the manufacture of the ingredient.
In a precautionary measure, Swissmedic arranged for other sartan-containing products that are authorized and available on the Swiss market to be investigated for potential contamination of NDMA. These products included valsartan, losartan, olmesartan, candesartan, and irbesartan, which all contain a tetrazole ring system that may be contaminated with nitrosamines during the formation process. Other products that contain sartans but do not have the tetrazole ring system were not included in this further investigation as they would not be affected by the nitrosamine issue.
The outcome of the investigatory work was that medical products containing sartans currently available on the Swiss market are considered to satisfactorily meet the safety requirements in terms of NDMA contamination.