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The Institute of Public Health of Chile (ISP) reported that the occurrence of an impurity, probably carcinogenic, has been detected in some drugs containing the active ingredient Valsartan, which is why it orders the market recall of these drugs.
Patients on treatment with any of these drugs, warned the ISP, should not suspend it abruptly, but should consult their doctor or chemist to evaluate an alternative treatment. Valsartan is a widely used drug for the treatment of high blood pressure
The ISP explained that the detected impurity is identified as N-nitrosodimethylamine or NDMA, and has been attributed to the change in the manufacturing process of the drug manufactured by Zhejing Huahai Pharmaceutical Co The above-mentioned laboratory is the supplier of this raw material to different laboratories that manufacture these drugs in the whole world and in our country, according to the European Medicines Agency (EMA) , which motivates the withdrawal of the drugs concerned. NMDA is a substance produced 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 As it causes cancer in humans, it has been clbadified by the International Agency for Research on Cancer (IARC) as being "probably carcinogenic to humans", it is therefore understood that exposure to NDMA does not necessarily cause a negative effect on
In view of this finding, the PSI has determined Preventive to order the recall of all batches of products containing Valsartan from the manufacturer Zahejing Huahai Pharmaceutical Co., which will be disclosed in detail in
The holders of the sanitary register badigned to this measure are as follows: [19659002] – Chemopharma SA
– Eurofarma Chile SA
– Galenicum Health Chile SpA
– Chile Laboratory SA
– Andrómaco SA Laboratories
– Laboratoires Lafi Ltda
– Laboratoire Recalcine SA
– Invested Pharma of Chile SA
The ISP has recommended that people who are treated with the affected drugs proceed as follows:
• Do not stop your treatment. It is necessary to remember 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 doctor or pharmacist pharmacist, who will have the necessary information to guide you.
• If it is necessary to replace your medications, eliminate the remaining units to prevent them from being consumed by mistake.
Finally, the ISP announced that it would continue to investigate and inform the population on the subject and remind health professionals to report any adverse events observed with the drug. 39, one of the formulations described in the e-mail [email protected].
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