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Blood pressure lowering products must be withdrawn from the market
Heumann Pharma GmbH & Co.Generica KG is once again recalling medical devices to lower blood pressure because they have been contaminated with harmful ingredients. According to the Federal Institute for Drugs and Medical Devices (BfArM), the contamination is a carcinogenic substance.
So-called antihypertensives are now being withdrawn from the market because they contain substances which, according to the Federal Institute for Drugs and Medical Devices (BfArM), can be carcinogenic. According to the manufacturer's information on its website, there is knowledge that there is an increased level of contamination with N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in various batches with the active ingredient losartan. In some batches, simultaneous contamination of N-nitrosodiethylamine (NDEA) and NMBA is said to have occurred. A corresponding recall for the affected products was published on March 7, 2019 in the Pharmaceutical newspaper, the German pharmacist newspaper and corresponding media.
These products are affected
As a precaution, the products are withdrawn from the market in order to avoid negative health effects for users. The following batches are specifically affected by the recall. All batches of Losartan comp. Heumann 100 mg / 12.5 mg film-coated tablets, 28, 56 and 98 film-coated tablets and all batches starting with the letters B and C from Losartan comp. Heumann 100 mg / 25 mg film-coated tablets, 28, 56 and 98 film-coated tablets.
Medications should not be discontinued without consultation
Customers who use the above-mentioned products to lower their blood pressure should not simply stop taking the medication without consulting a doctor, the manufacturer warns. The resulting health risk is many times higher than the possible risk from the existing contamination.
According to the manufacturer, there is no acute patient risk. A doctor should therefore be consulted for further therapy, the manufacturer adds on its website. (as)