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The Public Health Institute (ISP) announced the withdrawal of antihypertensive drugs containing the active ingredient Valsartan as a preventive measure, after having detected an "impurity, probably carcinogenic".
a statement, the agency reported that "the occurrence of an impurity, probably carcinogenic, has been detected in some drugs containing the active ingredient Valsartan, c. Is why instructs the withdrawal from the market of these drugs, preemptively ]
The ISP pointed out that "patients undergoing treatment with any of the affected drugs, should not suspend it abruptly but should consult their physician or pharmacist to evaluate alternative treatment. "
Regarding discovery, the body reported that" the impurity that has has been detected in the active ingredient used in the development n of some pharmaceuticals containing Valsartan, a drug widely used for the treatment of high blood pressure, is identified as N-nitrosodimethylamine or NDMA, and was attributed to the change of manufacturing process of the drug manufactured by Zhejing Huahai Pharmaceutical Co. of China . "
" The aforementioned laboratory is the supplier of this raw material to different laboratories that manufacture these drugs in the whole world and in our country, as announced the European Medicines Agency (EMA), motivating the withdrawal of drugs affected by several European agencies ", explains the ISP
The agency adds that" NMDA is a substance generated during the manufacturing process of Valsartan of the I & # 39; 39; establishment Zahejing Huahai Pharmaceutical Co. and is also present in other common sources such as: tobacco smoke, some processed food, toiletries, "
" Despite, adds the statement, "that 39, no report indicates that this substance causes cancer in humans, it has been clbadified by the International Agency for Research on Cancer (IARC). ) as "probably carcinogenic to humans" so it is understood that exposure to NDMA does not necessarily cause a negative effect on health. "
That is why the ISP, preemptively, determined" order the recall of all lots of products containing valsartan from the manufacturer Zahejing Huahai Pharmaceutical Co. which will be available in detail on the Institute's website. "
of the sanitary register badigned to this measure are the following:
- Chemopharma SA
- Eurofarma Chile SA
- Galenicum Health Chile SpA
- Laboratorio Chile SA
- Laboratorios Andrómaco SA
- aboratorios Lafi Ltda
- Laboratory Recalcine SA
- Pharma Invested in Chile SA
Recommendation to patients
It is recommended that persons who are treated with the affected drugs, proceed as follows:
- Do not suspend your treatment It is necessary to remember that this warning is a precaution, and that the sudden suspension can generate hypertensive crises, generally serious.
- There are several therapeutic alternatives both drugs with this active ingredient, and with other active ingredients for the same therapeutic purpose.
- See your doctor or a pharmacist, who may have the necessary information to guide you.
- If necessary replace your medicine delete the remaining units to prevent them from being consumed by mistake.
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