Valsartan Testing by FDA Officials May Lead to More Recalls for Blood Pressure Drug

As part of a continuing investigation into how a cancerous impurity got into generic valsartan drugs made overseas, the FDA is conducting additional testing, which may lead to additional blood pressure drug recalls. 

FDA Commissioner Scott Gottlieb and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research issued a statement on August 30, updating the public on preliminary findings of the valsartan investigation, which has already resulted in confirmation that several different forms of the generic hypertension drug contained the impurity N-nitrosodimethylamine (NDMA), which has been linked to a risk of liver cancer, kidney cancer and other digestive tract cancers.

“The FDA currently has a major operation underway to investigate and address this troubling finding,” Gottlieb and Woodcock say in the statement. “This investigation is led by a dedicated task force of experts focused solely on this important work. Their mandate is to oversee the investigation and track new developments and information coming in from valsartan manufacturers.”

The statement recaps the FDA’s actions leading to the recalls, and notes that the agency has now determined how processes could have led to the presence of NDMA in valsartan.

According to the FDA’s valsartan findings, a specific combination of conditions, which include the use of certain chemicals in the right processing conditions and production steps can lead to the formation of NDMA in the active pharmaceutical ingredient. The formation of the impurity occurs if the steps are done in a certain sequence, and the FDA indicates that this is the first time scientists and experts have come to understand how NDMA is formed accidentally.

Now, the FDA can evaluate other drug manufacturing processes that could lead to the formation of NDMA, and valsartan testing will be required in situations where the agency believes NDMA could form. It also allows the agency to determine whether other valsartan manufacturers have processes that could lead to NDMA, which may result in additional recalls.

“The initial recall has expanded to now include five manufacturers and other companies who repackage those products under a different name,” the statement indicates. “More products may need to be recalled.”

The statement notes that more than half of all valsartan products on the market are currently being recalled. However, they note that prescribers are still able to find a similar replacement product within the same class of drugs.

The first valsartan recalls were announced in Europe on July 5, after batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA. That initial recall affected about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada. The same manufacturer made the recalled Torrent Pharmaceutical pills.

The FDA followed with its own recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers.

The agency determined that a number of manufacturers have been distributing the contaminated pills for years. Like the EMA, the FDA also noted NDMA has been linked to cancer risks in animal studies and that the U.S. Environmental Protection Agency (EPA) determined that consuming up to 96 nanograms of NDMA per day is considered reasonably safe for human ingestion.

The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to druginfo@fda.hhs.gov.