Anvisa gives opinion on medicine in Brazil

Credit: Publicity/Sanofi Medley

The agency stated that the withdrawal came from the pharmaceutical company (Credit: Disclosure/Sanofi Medley)

The National Health Surveillance Agency (Anvisa) published, this Monday (14) a statement on the recall of medicines with the active ingredient losartan.

The agency reported that, so far, the suspensions of sales have taken place voluntarily by the pharmaceutical companies themselves. Anvisa also reported that there is no evidence that the impurities found in the medicines have caused damage to health.

+Laboratory collects drugs with Losartana from pharmacies in Brazil; see list

In September last year, the website of the European health surveillance authority warned that drugs from the sartana family could contain the impurity “azido”, which can cause mutations and change the genetic code of an individual.

“Based on information from the EDQM and, later, from the results of analyzes of this impurity carried out by manufacturers of IFA losartan, and even though they did not receive reports of adverse events that could be related to this finding, two companies that own drugs containing losartan reported to Anvisa, in a preventive way, the voluntary collection of its products”, said the note.

The agency also said that not all losartan drugs are being withdrawn from the market. Anvisa stated that notified the other companies that hold the registration of these drugs to assess the potential existence of this impurity in their products and awaits the submission of additional documentation.

Sanofi Medley announced last week that the following drugs had been recalled:

  • Valtrian® HCT (Losartan Potassium + Hydrochlorothiazide) 50mg + 12.5mg
  • Valtrian® 50mg and 100mg (losartan potassium) tablets

The company also stated that it is not safe for the patient to stop using the drug abruptly and recommends that you seek medical advice before making the change of medication.


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