Hypertension: Warning recall for hypotensive Candesartan - overdose threatens!

Hypertension: Warning recall for hypotensive Candesartan - overdose threatens!

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Candesartan: Known blood pressure lowering is called back

In the past, antihypertensive drugs have been recalled for contamination. These recall campaigns were usually carcinogenic substances that were discovered in medicines with the active ingredient “valsartan”. In the current recall, the wrong labeling of the ingredients is pointed out. The pharmaceutical company Puren Pharma GmbH & Co. KG has initiated a recall for candesartan, as labeling errors have been found in the widely used antihypertensive medication. This could lead to overdoses and significant health problems for those affected. The manufacturer recommends “returning the affected batches to pharmacies immediately”.

Labeling errors concern the indication of the strength

The pharmaceutical company Puren Pharma GmbH & Co. KG carries out a batch recall for candesartan. "A labeling error was found. The error relates to the indication of the strength on the folding box: 32 mg / 12.5 mg instead of 32 mg / 25 mg, ”says a message from the company. But: "The tablets contained agree with the information on the blisters."

Funds affected by the recall

As the Medicines Commission of the German Pharmacists (AMK) informs, the following preparations are affected by the recall:

Candesartan-comp PUREN 32 mg / 25 mg, 98 tablets
Candesartan-comp PUREN 32 mg / 12.5 mg, 98 tablets

PZN: 11354037 and 11354008

Ch.-B .: JDSB18002-A, JDSB18003-A, JDSB18004-A, JDSB18005-A, JDSB18006-A, JDSB18007-A, JDSB18008-A, JDSB18009-A, JDSB18010-A, JDSB18011-A, JDSB1801 JDSB18012-A, JDSB18013-A, JDSB18014-A, JDSB18015-A

According to the announcement, this information was sent to the branches of the pharmaceutical wholesale trade for forwarding to the public pharmacies and to the regional pharmacy chambers. The hospital pharmacies were informed by the AMK office.

Customers should be informed

According to the announcement, AMK-PHAGRO quick information on another batch of the aforementioned drugs was published on April 25, 2019. The AMK asks to check the inventory.

"Pharmaceuticals and wholesalers must immediately block affected pharmaceuticals from sales," says the message.

"The pharmaceutical company asks pharmacies to inform customers who are known to have received one of the preparations with the batches mentioned."

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The affected goods were first delivered on July 16, 2018.

Medicament to treat high blood pressure

Candesartan is a sartan. These so-called angiotensin II receptor antagonists 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.

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

Contamination with carcinogenic substances

There have been several warnings in recent months about contaminants in such high blood pressure medications.

Some of the preparations had to be recalled because of the carcinogenic substances they contained.

These recalls mainly concerned products manufactured by Indian and Chinese producers.

Blood pressure medication had to be recalled across Europe. Valsartan-containing medicines for high blood pressure were affected. The active ingredient of the Chinese manufacturer "Zhejiang Huahai Pharmaceutical" was contaminated with a carcinogenic substance according to official authorities. (Ad)

Author and source information

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