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The Directorate General of Drugs, Supplies and Medicines (Digemid) of the Ministry of Health (Minsa) ordered the withdrawal of 33 products containing valsartan (active ingredient used for arterial hypertension) in response to warnings of Ministry of Health. The European Medicines Agency (EMA) and the Spanish Agency for Medicines and Health Products (AEMPS), who warned that they had found a possibly carcinogenic impurity.
This measurement was made after detection of N-nitrosodimethylamine (NDMA) in the active ingredient of valsartan manufactured by the Chinese company Zhejing Huahai Pharmaceutical Co. Ltd. This impurity was generated as a result of a modification of the manufacturing process of valsartan in several presentations.
In order to preserve the health of the population, the Digemid communicated and visited the laboratories and pharmacies holding the sanitary registers of the products which contain in their composition valsartan, having identified 104 batches of 33 products, the same as they were immobilized and will be withdrawn from the national market, as indicated in Alert N ° 35-2018 published on its website: http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Alertas/2018/ALERTA_35- 18.pdf
Similarly, Digemid informs healthcare professionals that, in the case of patients undergoing treatment with one of the medications with valsartan, they must replace it with another one that is not not included in this alert.
Also asks health facilities that have these products at risk to immobilize them and to contact their suppliers for the corresponding actions.
Digemid advises patients not to interrupt their treatments and to consult their doctor or pharmacist to inform them if their medication is withdrawn from the market and to replace it with a drug from a batch that is not contaminated by this impurity. the NDMA.
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