Following a rash of blood pressure medication recalls over the last two months, Camber Pharmaceuticals has also recalled 87 lots of Losartan Potassium tablets USP for the detection of a cancer-causing impurity. Distributed nationwide online and by pharmacies and retailers including Walmart and Sam's Club, the drug was found to contain trace amounts of a potential human carcinogen, the New Jersey drug company said in a news release. The active drug ingredient was made at Hetero Labs Restricted in India, one in all two overseas drug factories linked to repeated blood treatment recollects since final July.
USA health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.
The FDA said increased risk of cancer in patients exposed to the new impurity, NMBA, appeared to be the same as those exposed to NDMA, but less than the risk from NDEA. Here's a list of the latest products recalled. That said, any presence of such impurities in drug products is not acceptable. It's the first ARB recall involving the presence of NMBA, which is the third type of nitrosamine impurity detected in the medications, the FDA said. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA.
"We're continuing to share these testing methods with worldwide regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity".
The agency and companies are testing all ARBs for impurities.
"Before they found this particular compound, they didn't even know there could be a chemical reaction that could produce the compound", she said.
The FDA says no one has reported any adverse effects from the drug and patients should speak with their doctor to discuss the recall before they stop taking the drug.
Camber and Macleods are among the half dozen pharmaceutical firms that have recalled hypertension drugs found to contain possible carcinogens since early December.