The recent valsartan cancer recall is in full swing, with patients alleging they developed chronic health complications soon after being prescribed the blood pressure medication.

The valsartan cancer recall was recently expanded by the FDA to include medications that contain valsartan and hydrochlorothisazide, after it was found that these medications could have also been contaminated during manufacturing stages.

Initially, the valsartan cancer recall was announced in July 2018 after it was discovered that some medications could have been contaminated with N-nitrosodimethylamine, or NDMA. This contaminant is considered potentially carcinogenic by the Environmental Protection Agency (EPA), and was found initially in samples sourced from Chinese manufacturer Zhejiang Huahai Pharmaceuticals.

Overview of Valsartan and Cancer Recall

Valsartan is the generic variant of Diovan, which is popularly prescribed to help patients control their blood pressure and lower the chances of heart attack. Valsartan works by reducing the construction of blood vessels, which allows for easier medication.

Due to this treatment mechanism, this medication can be prescribed to treat adults and young children, and can even be prescribed to reduce to the risk of death in patients who recently suffered a heart attack.

This medication has helped millions of patients in the United States, but the recent NDMA contamination discovery has suggested that patients may have faced an increased cancer risk for years.

NDMA is an organic chemical often used to make liquid rocket fuel. It can be accidentally released through certain chemical reactions. It is often produced as a byproduct of pesticide and fish processing during the manufacturing process.

The European Medicines Agency announced the contamination finding in May 2018, which spurred the beginning of the valsartan cancer recall in over 20 different countries. Additional valsartan products were recently added to the recall as well, after it was discovered that samples from Hetero Labs Ltd. in India may have also been contaminated.

While the valsartan cancer recall does not affect all medications containing the ingredient, drugs produced by the following packagers may be subject to the recall:

• AvKare
• A-S Medication Solutions LLC
• Bryant Ranch Prepack Inc.
• Camber Pharmaceuticals, Inc.
• H J Harkins Company
• Northwind Pharmaceuticals
• NuCare Pharmaceuticals Inc.
• Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC)
• Proficient Rx LP
• Remedy Repack
• Teva Pharmaceuticals (labeled as Major Pharmaceuticals)
• Teva Pharmaceuticals USA (labeled as Actavis)

To help prevent confusion, the FDA also published a list of valsartan medications not subject to the recall that are safe to use.

Patients Advisory

Patients are currently being advised to check the name of the manufacturer on the prescription bottle, and call their pharmacy for further questions. Pharmacists are currently being asked to clear affected valsartan medications from their stock, and return them to manufacturers.

Concerned patients can also talk with their doctor over the potential NDMA contamination. However, even if patients are taking a medication affected by the valsartan cancer recall, they are not advised to discontinue the medication without consulting their physician.

While Zhejiang Huahai Pharmaceuticals reported the contamination when it was discovered, the drugs were already on the market. The FDA stated that it is currently working with drug manufacturers “to ensure future valsartan active pharmaceutical ingredients are not at risk.”