[ad_1]
The Institute of the Public Health of Chile (ISP) reported that it detected the occurrence of an impurity, probably carcinogenic, in certain drugs which contain the active ingredient Valsartan for which he orders the recall of these drugs in a preventive manner.
The patients in treatment with any of these drugs warn the ISP, for no reason, they should suspend him abruptly, but should consult their physician or Pharmaceutical pharmacist to evaluate alternative treatment. Valsartan is a widely used drug for the treatment of hypertension
The ISP explained that the detected impurity is identified as N-nitrosodimethylamine or NDMA and was attributed to the change in the manufacturing process of the drug manufactured by Zhejing Huahai Pharmaceutical Co. of China
The abortion mentioned is the supplier of this raw material to different laboratories that manufacture these drugs worldwide and in our country, according to European Medicines Agency (EMA)) motivating the withdrawal of the affected drugs by several agencies of this continent.
NMDA is a substance generated during the manufacturing process of Valsartan by Zahejing Huahai Pharmaceutical Co. and is also present in other common sources such as tobacco smoke, certain processed foods, toiletries, among others.
Although there is no report indicating that this substance causes cancer in humans, it was clbadified by the International Agency for Research Cancer Research ( IARC) as "probably carcinogenic to humans" It is therefore understood that exposure to NDM A does not necessarily cause a negative effect on health.
In view of this finding, PSI has decided as a precautionary measure to order the recall of all lots of products containing Valsartan from the manufacturer Zahejing Huahai Pharmaceutical Co., which will be disclosed in detail on the site [19659008] of the Institute
The holders of the sanitary register badigned to this measure are the following:
► Chemopharma SA
► Eurofarma Chile SA
► Galenicum Health Chile SpA
► Laboratory SA from Chile
► Laboratorios Andrómaco SA
► Laboratorios Lafi Ltda
► Laboratorio Recalcine SA
► Pharma Investi de Chile SA
The persons recommended by the ISP who are treated with the affected drugs, proceed as follows:
► Do not suspend your treatment . It should be remembered that this warning is preventive, and that the sudden suspension can generate hypertensive crises, generally serious.
► There are multiple treatment alternatives, both drugs with this active ingredient and with other active ingredients for treatment. same therapeutic purpose. Consult your pharmacist or pharmacist who will have the necessary information to guide you.
► If it is necessary to replace your drugs, eliminate the remaining units to prevent them from being consumed by: error
Finally, the ISP has announced that he will continue to investigate and inform the public on the matter and remind health professionals to report any adverse events observed with any of the formulations described in the email cenimef @ ispch.cl [19659017].
[ad_2]
Source link
