FDA Identifies Repackaged Valsartan Pills That May Contain Cancer-Causing Impurities

Amid mounting concerns about the link between generic valsartan and cancer, federal drug safety officials are expanding a recall for the widely used hypertension drug, after discovering that additional companies may have repackaged valsartan contaminated with cancer-causing impurities.

In a valsartan recall update issued on July 27, the FDA indicates that additional products from three repackagers were being added to the list of potentially impacted medications.

With many consumers concerned about whether their blood pressure drug may contain a cancer-causing ingredient, the agency has also created a list of valsartan products that are not being recalled.

The initial generic Diovan (valsartan) recall was 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, which has been linked to a risk of liver cancer, kidney cancer and other types of cancer. That recall affected about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada.

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

This latest update adds three repackagers of Teva Pharmaceuticals and Prinston Pharrmaceuticals to the total list of recalled valsartan products, including:

• A-S Medication Solutions LLC
• AvKARE
• RemedyRepack

In addition, the following companies are either in the process of recalling valsartan products, or are expected to recall them:

• Bryant Ranch Prepack Inc.
• H.J. Harkins Company, Inc.
• Lake Erie Medical, doing business as Quality Care Products LLC
• NuCare Pharmaceuticals
• Proficient Rx

The FDA notes that it is possible that not all valsartan products by these companies will be impacted by the recalls.

In addition to the updated recall lists, the FDA also released more information about the potential risks of NDMA.

The agency has determined that the Chinese manufacturer has been distributing the contaminated pills for four years. The agency also noted that animal studies have indicated 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 amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels,” the update indicates. “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. This assessment led to FDA’s decision to have these batches recalled.”

The FDA reviewed valsartan 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.

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.

A number of consumers who have been diagnosed with liver cancer, kidney cancer, lung cancer or suffered an acute liver injury in recent years are now reviewing whether they may be eligible for compensation through a valsartan lawsuit against the manufacturers of the generic drug, with lawyers providing free consultations and case evaluations for individuals nationwide.