Investigation of medicinal products containing valsartan: First analytical results now available
Bern, 27.08.2018 - Following the valsartan recalls in Switzerland and other countries, the extent of this impurity in medicines and active substances is under investigation. In Switzerland, the first results from Swissmedic's own laboratory are now available: According to these investigations, valsartan preparations approved for sale in Switzerland and currently obtainable on the Swiss market are compliant.
At the start of July, batches of antihypertensive medicines containing the active substance valsartan and contaminated with elevated concentrations of N-nitrosodimethylamine (NDMA) were recalled worldwide as a precautionary measure. These batches have since between withdrawn from sale in Switzerland. Following the recalls, authorities and manufacturers started investigating whether other preparations might also be affected.
To this end, Swissmedic has asked for samples of valsartan-containing medicinal products that are not affected by the recall and that are still on the market in Switzerland. Swissmedic's own laboratory has checked whether these products satisfy the requirements.
Valsartan preparations currently available on the Swiss market are safe
The results of the accredited Swissmedic laboratory (OMCL) for those preparations containing valsartan that are not affected by the recall are now available: No increased levels of NDMA were detected in the tested batches of medicinal products containing valsartan on the Swiss market.
Swissmedic ensures safety through transparency
In the coming weeks, the Swissmedic laboratory will be testing other medicinal products containing sartans. New batches of valsartan preparations intended for the Swiss market will also be analysed. Swissmedic has therefore requested samples from the authorisation holders, and will also ask the companies to keep sending samples from every new batch of valsartan intended for sale in Switzerland until further notice.
As soon as results are available, Swissmedic will publish a list of preparations and batches that were analysed by the laboratory. If the resulting NDMA levels are above the safety limit of 300 ppb, the corresponding batch will be withdrawn from the Swiss market.
The batches that are recalled as a precaution will also be tested to determine the actual content of NDMA in the corresponding preparations (the recall was based on analyses carried out by companies).
The publication of the preparations and batches for which the safety limit is not exceeded, and can thus be administered without any concerns, is designed to create transparency about the current situation.
Address for enquiries
Swissmedic
Media Unit
phone +41 58 462 02 76
media@swissmedic.ch
Publisher
Swiss Agency for Therapeutic Products
http://www.swissmedic.ch/?lang=2
