Again, recall for high blood pressure medications because of impurities

Antihypertensive: Renewed Valsartan Recalls

Since the beginning of July of this year, several recalls for high blood pressure medications with valsartan were started after it became known that the drugs were contaminated. Now again blood pressure lowering are recalled.

Recall for valsartanhaltige drugs

At the beginning of July, the German Federal Institute for Drugs and Medical Devices (BfArM) had started a recall for valsartan-containing drugs from the Chinese manufacturer "Zhejiang Huahai Pharmaceuticals" because carcinogenic impurities had been found in the antihypertensive drugs. In September it was confirmed that also preparations of the Indian company Hetero Labs were contaminated. It was then reported in November that valsartan from Mylan Laboratories Limited of Hyderabad, India, may not be used for the production of valsartan-containing medicines in the EU until further notice. And now again blood pressure lowering are recalled.

Following the recall of various antihypertensive drugs in recent months due to contamination, a recall for such drugs has now been started again. (Image: benjaminnolte / fotolia.com)

Contamination with carcinogenic substances

The two pharmaceutical companies Aurobindo and Puren call back individual batches of Valsartan.

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

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

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

Four other preparations

According to the Pharmacists Commission of the German Pharmacists (AMK), the current products are:

• 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, lots: VJSB17015-A, VJSB17016-A, VJSB18001-A
• Valsartan Aurobindo 160 mg, 98 film-coated tablets, Batch: VJSC17005-C

According to the data, the NDEA value for the Puren batch mentioned was 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 pointed out that according to their own assessment, there is no acute patient risk.

As with previous contaminants, health professionals point out that they should never stop using blood pressure alone.

Patients should discuss their further treatment with a doctor or pharmacist.

For the treatment of various diseases

Sartans (including candesartan, irbesartan, losartan, olmesartan and valsartan) are angiotensin II receptor antagonists used to treat arterial hypertension (high blood pressure).

Also in heart failure (heart failure), after a recent heart attack or in patients who have kidney disease and additionally hypertension and type 2 diabetes mellitus, these drugs are used.

The preparations are available alone or in combination with other drugs.

In some cases, these remedies are used to lower high blood pressure because taking other medicines leads to persistent irritable cough in the patients. (Ad)