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Recall for high blood pressure medication due to contamination

Recall for high blood pressure medication due to contamination


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Antihypertensive drugs: Valsartan recalls again

Since the beginning of July this year, several recall campaigns for high blood pressure medication with valsartan have been launched after it became known that the medication was contaminated. Now blood pressure reducers are called back again.

Recall for medicinal products containing valsartan

At the beginning of July, the Federal Institute for Drugs and Medical Devices (BfArM) started a recall for medicinal products containing valsartan from the Chinese manufacturer "Zhejiang Huahai Pharmaceuticals" because carcinogenic contaminants had been found in the hypotensive preparations. In September it was then confirmed that preparations from the Indian company Hetero Labs were also contaminated. In November it was then reported that valsartan from Mylan Laboratories Limited in Hyderabad, India, may not be used for the manufacture of medicinal products containing valsartan for the EU until further notice. And now blood pressure reducers are being called back.

Contamination with carcinogenic substances

The two pharmaceutical companies Aurobindo and Puren are recalling individual batches of valsartan.

According to the information, the recall is due to traces of contamination with N-nitrosodiethylamine (NDEA) in the active ingredient valsartan.

The two companies had already recalled medication for N-nitrosodimethylamine (NDMA) in the summer.

Both NDEA and the chemically related substance NDMA, which has already been found in other sartans, are classified as potentially carcinogenic.

Four other preparations

According to the Medicines Commission of the German Pharmacists (AMK), the current product recalls are as follows:

  • Valsartan Puren 160 mg, 98 film-coated tablets (can), batch: VJSC18013-B
  • Valsartan Aurobindo 40 mg, 28 film-coated tablets, batch: VJSA18003-B
  • Valsartan Aurobindo 80 mg, 98 film-coated tablets, batches: VJSB17015-A, VJSB17016-A, VJSB18001-A
  • Valsartan Aurobindo 160 mg, 98 film-coated tablets, lot: VJSC17005-C

According to the information, the NDEA value for the mentioned pure batch is 0.106 µg / g and for the Aurobindo batches between 0.116 and 0.298 µg / g and thus above the limit of 0.082 µg / g.

Aurobindo has indicated that it believes that there is no acute risk to the patient.

As with previous contaminants, health experts advise that blood pressure therapy should not be ended by hand.

Rather, patients should discuss their further treatment with a doctor or pharmacist.

For the treatment of various diseases

Sartans (these include candesartan, irbesartan, losartan, olmesartan and valsartan) are so-called angiotensin II receptor antagonists, which are used to treat arterial hypertension (high blood pressure).

These medications are also used for heart failure (heart failure), after a recent heart attack, or for patients who have kidney disease and who also have hypertension and type 2 diabetes mellitus.

The preparations are available alone or in combination with other active ingredients.

In some cases, these remedies are used to lower high blood pressure because taking other medications leads to persistent coughing in patients. (ad)

Author and source information



Video: 3 Companies Recall Blood Pressure Medications Over Cancer Fears. TIME (December 2022).