Valsartan Recalls Announced By FDA Over Impurities, Cancer Risks

Federal drug regulators have announced a valsartan recall in the United States, joining 22 other nations that are recalling the generic version of the hypertension drug Diovan due to concerns about impurities, which may increase the risk of cancer. 

In a press release on issued on July 13, the FDA indicated that some generic Diovan (valsartan) may contain an impurity known as N-nitrosodimethylamine (NDMA), which is a probable human carcinogen.

To date, recalled products in the U.S. include Valsartan and Valsartan HCTZ tablets distributed by Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals, and Prinston Pharmaceuticals.

The move follows a generic Diovan recall announced by the European Medicines Agency (EMA) on July 5, after batches of the active ingredient, supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA. That recall affected about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada.

The EMA launched a safety review of generic valsartan, and the FDA has now announced that it is conducting its own safety review as well. The FDA review will look at the levels of NDMA in the recalled pills, and the possible effects on patients. The agency is also looking at what can be done to reduce or eliminate the impurity, thought to be a by-product of the manufacturing process, from future batches.

The FDA is also taking action to prevent any drug shortages that may be caused due to the recall, FDA Commissioner Scott Gottlieb said in the press release.

“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market,” Gottlieb said. “As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

The FDA reviewed Diovan and similar medications in 2010, after some data suggested they may increase the risk of cancer. However, in 2011, the FDA reviewers indicated they could find no link between the drugs, known as angiotensin receptor blockers (ARBs) and cancer.

It is unclear whether the 2010 review and cancer concerns are connected in any way to last week’s recall. Valsartan was originally developed and sold by Novartis, and is now off-patent and sold as a generic.

The FDA recommends patients continue taking generic valsartan until they have a replacement product, look at the drug name and company name on the label or contact the pharmacy to see if their medications are on the recall list, follow the recall instructions provided by the manufacturer, and contact their health care professional to discuss alternative treatment.

The agency also asks any patients or healthcare professionals to report any adverse events related to the use of the recalled drugs to the FDA’s MedWatch Adverse Event Reporting program.