Numerous blood pressure medications are now involved in the recall that began in July 2018 on an alleged cancer-causing compound.
A pharmaceutical company has expanded the withdrawal of its blood pressure medications, the latest development in a long list of withdrawals that have been going on for the past 14 months.
Torrent Pharmaceuticals announced to Trusted Source last week that it was extending its recall to 3 additional lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium / Hydrochlorothiazide Tablets, USP.
Company officials said an impurity suspected of being a carcinogen was found in the finished manufactured version of the tablets.
Dozens of blood pressure medications have been recalled since the first products were recalled in July 2018 due to impurities.
All affected products contained valsartan, losartan or irbesartan. These belong to a class of medications known as angiotensin II receptor blockers (BRA), which are used to treat high blood pressure and heart failure.
What impurities are in the medications?
The recalled products contained N-nitrosodimethylamine from a reliable source (NDMA), N-Nitrosodiethylamine (NDEA) or N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the levels considered safe by the FDA.
NDMA and NDEA are “probable human carcinogens” and NMBA is a “potential human carcinogen,” according to the FDA.
In addition, the Valisure online pharmacy filed a petition in June with the FDA, saying it found the chemical dimethylformamide (DMF) in certain valsartan products.
The World Health Organization mentioned DMF as a probable carcinogen last year.
An FDA official told CBS News that the agency will investigate Valisure’s claim.
How did the impurities enter?
According to the U.S. Environmental Protection Agency. UU. (EPA), NDMA is formed during industrial and natural processes.
Previously it was used in the production of liquid fuel for rockets, antioxidants and lubricant additives.