The U.S. Food & Drug Administration (FDA) has added tablets marketed by another manufacturer to the massive valsartan recall for blood pressure and heart medications that may contain a cancer-causing chemical.
The recall expansion was announced after a generic version of valsartan distributed by Camber Pharmaceuticals was found to contain traces of N-nitrosodimethylamine (NDMA). Unlike previous recalls, the affected tablets were manufactured by Hetero Labs in India.
As a precautionary measure, Camber Pharmaceuticals is voluntarily recalling the following unexpired lots with expiration dates 7/2018 through 6/2020:
The Camber Pharmaceuticals valsartan recall is being conducted at the hospital, retail, and consumer level. However, no adverse events, including cancer, have been linked to these valsartan products.
Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this product. Pharmacies and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) by the World Health Organization’s International Agency for Research on Cancer (IARC).
Valsartan recalls for NDMA contamination began earlier this summer and have ensnared dozens of pharmaceutical companies. However, the active ingredient used in the previously-recalled drugs was made by Zhejian Huahai Pharmaceuticals in China.
The issue is thought to have resulted from a change in Zhejian Huaha’s production methods. Hetero Labs uses a similar process.
Adding to concerns, regulators in Europe announced on August 10th that NDMA had been found in drug ingredients manufactured by a second Chinese company, Zhejiang Tianyu.
So far, NDMA levels found in Zhejiang Tianyu and Hetero Labs valsartan is significantly lower than what was detected in drugs made by Zhejian Huahai Pharmaceutical. That company altered the manufacturing process in 2014, thus its tainted valsartan pills may have been circulating for as long as 4 years.
“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 said in a statement posted on its website. “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, on its website.