The U.S. Food & Drug Administration (FDA) is testing more heart drugs for a cancer-causing chemical, following a series of generic valsartan recalls that began over the summer.
Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.
According to an FDA statement issued on August 30th, the agency will now be testing all ARBs for the presence of N-nitrosodimethylamine (NDMA).
Other ARB’s include losartan, telmisartan, olmesartan, irbesartan, eprosartan, candesartan and azilsartan.
While none of these medications have been recalled, the process for manufacturing other ARBs is often similar to the process that was used to make the tainted valsartan products. This has led to concerns that other heart and blood pressure medications within the ARB class might also be tainted with NDMA.
“These tests will continue until we identify all products that may contain NDMA in the ARB class, and they are no longer available in the U.S.,” the agency said. “And our robust investigation continues, as do our efforts to mitigate these risks and prevent them from recurring.”
Valsartan recalls have ensnared 5 generic drug makers and multiple distributors. More than 23,000 batches of valsartan and valsartan-containing medications have been recalled in 22 countries.
Most of the recalled drugs contained active ingredient supplied by China-based Zhejiang Huahai Pharmaceuticals. According to the FDA, the NDMA contamination may have occurred after the supplier altered its production methods. That change occurred in 2014, so tainted valsartan may have been on the market for at least the last 4 years.
NDMA was also found in active ingredient manufactured by an Indian company, Hetero Labs and a second Chinese company, Zhejiang Tianyu. So far, however, NDMA levels found in product from those two suppliers have been significantly lower than what was detected in active ingredient obtained from Zhejian Huahai Pharmaceutical.
NDMA is an organic chemical found in rocket fuel. It may also occur as a byproduct of certain production processes. The U.S. Environmental Protection Agency (EPA) has classified NDMA as a probable human carcinogen based on findings from animal experiments. The chemical has also been linked to liver damage.
“FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people,” the agency stated. “This assessment led to FDA’s decision to have these batches recalled.”
Not all valsartan products currently on the market are affected by these recalls. The FDA has posted an updated list of products included in the valsartan recall, as well as a list of products not included in the recall.
Patients should not stop taking their medication even if their valsartan is included in the recall, as doing so could result in serious health consequences. Rather, they should contact their doctor to arrange for an alternative treatment.