Valsartan has been recalled by numerous drug manufacturers, many removing multiple lots of the blood pressure medication from the market.

What is Valsartan?

Valsartan is a high blood pressure medication that is part of the drug class known as angiotensin II receptor blockers (ARBs). Losartan, irbesartan, and other “-sartan” drugs are also part of this class of drugs.

Why Has Valsartan Been Recalled?

The U.S. Food and Drug Administration (FDA) has recalled numerous lots of valsartan. Losartan and irbesartan have also been recalled due to concerns that the high blood pressure medications are contaminated with nitrosamine impurities.

Low levels of nitrosamines, which are environmental contaminants, may be found in water and certain foods such as meat, dairy products, and vegetables. This includes N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) which are all classified as probable or potential human carcinogens.

Although these impurities are carcinogens, it is unclear how much the contamination has increased patient risks for cancer.

The source of the contamination reportedly lies in the drug’s active ingredient, API, manufactured by Zhejian Huahai Pharmaceuticals, a lab based in China. This lab reportedly supplies valsartan API to numerous manufacturing companies that make the finished valsartan tablets. Some of these companies then sell their product to repackaging companies. As a result, there have been countless companies involved in the recall since their supply chain is heavily linked.

The FDA is carefully overseeing the massive valsartan recall and has reportedly been testing medications containing valsartan to determine the scope of the contamination.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” FDA Commissioner Scott Gottlieb said in a 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.”

Manufacturers Continue to Receive FDA Warning Letters

An FDA warning letter was recently sent to Mylan concerning possible contamination of valsartan at a plant located in India. The Food and Drug Administration’s warning letter reportedly states that the drugmaker has significantly deviated from best practices in manufacturing at their India based plant. The warning letter was dated Nov. 5, 2019, and it involves valsartan, an active ingredient popular in many high blood pressure medications.

Multiple recalls have been associated with valsartan and many of these medicines are the focus of a global investigation by the FDA because of probable carcinogenic contamination.

The FDA noted that Mylan was responsible for improper identification and handling of raw materials to prevent contamination and inappropriate written procedures, in addition to failure to adequately clean utensils and equipment. Mylan recalled all of their valsartan batches in December 2018 after tests identified that the majority of batches contained a probable carcinogen, nitrosamine (NDMA), above the allowed limit.

The FDA’s global investigation of these issues centers upon pharmaceutical plants located outside of the United States. For companies bringing in medications made out of U.S. borders, the risk of contamination poses serious problems for consumers in the U.S. taking the drugs.

Investigations of foreign plants are meant to be conducted regularly so that improper processes are identified and corrected. When news broke over impurities in valsartan drugs, several plants abroad have been named in investigations. If cancer-causing impurities are introduced in the manufacturing process and end-users are ultimately diagnosed with a related condition, those consumers could hold manufacturers accountable in litigation.

Why Is There a Quality Control Issue?

Beginning in the 1990s, U.S. pharmaceutical companies began using factories overseas to manufacture their medications. The Government Accountability Office reports nearly 40 percent of all final drug products are made outside the U.S., which means the manufacturing is largely outside of America’s control.

About 80 percent of active pharmaceutical ingredients (API) are made outside the U.S. as well because it is less expensive to do so.

The FDA continues to inspect how the drugs became contaminated, but believe the contamination was unintentional and perhaps a result of an unforeseen chemical reaction during the manufacturing process. This contamination is why valsartan has been recalled.

The increased risk of cancer from taking contaminated valsartan was estimated by the FDA, which said if 8,000 patients took the highest dose of valsartan (320 milligrams) from a recalled batch daily for four years, one additional cancer diagnosis would be discovered throughout the lives of the 8,000 patients. In other words, one in three Americans would receive a cancer diagnosis in their lifetime.

It’s important to understand that the recalls are not related to side effects of valsartan, but to a contaminant within certain lots of the medication manufactured mainly in China and India.

Common side effects of valsartan, when taken to treat high blood pressure, may include a headache, dizziness, flu-like symptoms of fever and body aches, fatigue and stomach pain. These side effects are not from contamination, but may be experienced as the drug does its intended job of lowering blood pressure.

What Valsartan Has Been Recalled?

Valsartan has been recalled by numerous manufacturers and their subsidiaries, including:

• A-S Medication Solutions LLC
• Acetris Health LLC
• Actavis Pharma Inc.
• American Health Packaging
• Aurobindo Pharma USA Inc.
• AvKare Inc.
• Bryant Ranch Prepack Inc.
• Camber Pharmaceuticals Inc.
• GSMS Incorporated
• Golden State Medical Supply
• H J Harkins Company Inc. d/b/a Pharma Pac
• Heritage Pharmaceuticals Inc.
• Hetero Labs Inc.
• Legacy Pharmaceutical Packaging LLC
• Macleods Pharmaceutical Ltd.
• Major Pharmaceuticals Inc.
• Mylan Pharmaceuticals Inc.
• Northwind Pharmaceuticals LLC
• NuCare Pharmaceuticals Inc.
• Preferred Pharmaceuticals Inc.
• Prinston Pharmaceutical Inc.
• RemedyRepack Inc.
• Rising Pharmaceuticals Inc.
• Sandoz Inc.
• ScieGen Pharmaceuticals Inc.
• Solco Healthcare LLC
• Teva Pharmaceuticals USA Inc.
• Torrent Pharmaceuticals Ltd.
• Vivimed Labs Ltd.
• Westminster Pharmaceuticals LLC

The FDA has published a full list of the recalled valsartan lots on its website.

Due to the high quantity of valsartan, losartan, and irbesartan tablets recalled over contamination concerns, the public is worried about an ARB shortage. If there were not enough ARBs for patients, other blood pressure medications would need to substitute while the shortage persists. The FDA is reportedly monitoring the situation and developing strategies to prevent shortages.