FDA Criticized Over Slow Valsartan Cancer Review

Published on October 11, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) is taking too long to evaluate the safety of Valsartan and other generic heart and blood pressure drugs that may contain a cancer-causing chemical, according to a prominent consumer advocacy group.

“Americans expect their blood pressure medication to treat their conditions, not cause cancer,” Adam Garber of U.S. PIRG, said in a statement issued on October 10^th. “The FDA has an obligation to meet its own self-imposed safety timeline to ensure that the millions of patients who need these drugs aren’t exposed to carcinogens.

FDA Announced First Valsartan Recall Over a Year Ago

Valsartan was the first of multiple generic heart failure and blood pressure drugs recalled beginning last summer, after N-Nitrosodimethylamine (NDMA) was detected in active ingredient supplied by manufacturers in India and China. Classified as a probable human carcinogen by the Environmental Protection Agency, animal studies suggest NDMA is associated with an increased risk of liver, kidney, pancreatic, and gastrointestinal cancers.

In the ensuing months, several other carcinogenic nitrosamines were detected in valsartan, losartan, and irbesartan ingredients sourced from overseas suppliers.

More than a year later, the valsartan recalls continue. However, not all sartan products are affected. Patients who use generic versions should patients should check the FDA’s regularly updated lists of recalled  valsartan, losartan and irbesartan products to determine if their medication has been recalled.

Those with a recalled drug should contact their doctor or pharmacist for a replacement. However, they should continue using the medication until the replacement drug is in hand, as stopping treatment entirely could result in potentially life-threatening heart and blood pressure events.

FDA Has only Reviewed 26% of Generic Sartan Medications on the Market

In March, the FDA temporarily increased the allowable limits of nitrosamines in valsartan, irbesartan, and losartan  while it conducted a 6-month review to evaluate their toxicity. But during that time, the agency has only managed to review 26% of the generic sartan medications currently on the market. According to PIRG, the FDA has so far detected nitrosamines at levels that exceed the temporary limits in 61% of the  drugs its’ examined.

Nevertheless, the FDA is allowing generic drug makers to continue distributing valsartan, irbesartan, and losartan products in the United States, apparently hoping that spot inspections will identify tainted drugs before they end up in pharmacies.

As PIRG noted, high blood pressure is a chronic condition that requires constant treatment. Many patients use sartan medications for years or even decades, increasing the chance that nitrosamine contamination could lead to cancer.

PIRG called on the FDA to take the following immediate actions:

• Provide resources and tools to increase production from companies whose drugs have not contained the carcinogen.
• Set a clear public timeline for assessing all manufacturers to ensure their drugs are nitrosamine free. Regularly update doctors and the public on which manufacturers have been approved.
• Help pharmacists and doctors suggest alternative, uncontaminated medication or ensure safe supply for patients.