Valsartan is a commonly prescribed generic drug to treat high blood pressure. The US Food and Drug Administration (FDA) began recalling hundreds of products containing Valsartan in July 2018 due to contamination with carcinogens (chemicals that cause cancer). Authorities believe the contamination started in 2012, when drug company Zhejiang Huahai Pharmaceutical Co. (ZHP) of China changed the way it manufactures Valsartan. The FDA later recalled a similar high blood pressure drug, Irbesartan, because it was also contaminated with a carcinogen. The contaminated drugs are generics made in China and India, and sold worldwide. Some patients are filing lawsuits. In this article, our personal injury lawyers will address:
- 1. What is Valsartan?
- 2. What high blood pressure drugs have been recalled?
- 3. What is the timeline of Valsartan recalls?
1. What is Valsartan?
Valsartan is the generic version of the drug Diovan. It is used to treat high blood pressure and heart failure. Doctors may also prescribe it to people who have had a heart attack, or who have type II diabetes. Valsartan is an angiotensin II receptor blocker (ARB), which means that it widens blood vessels.
Some Valsartan was contaminated with chemicals that can cause cancer and other illnesses. These chemicals are N-nitrosodimethylamine (NDMA), and in some cases also N-nitrosodiethylamine (NDEA). NDMA and NDEA are known to cause cancer in animals, and expected to cause cancer in humans. Most generic drugs are made in China and India, which is where the Valsartan contaminated with cancer-causing chemicals was made.
2. What high blood pressure drugs have been recalled?
The FDA has recalled some lots of these blood pressure drugs:
because they are contaminated with chemicals that can cause cancer. The chemicals are called NDMA and NDEA. These chemicals are known carcinogens in animals, and are expected to be carcinogens in humans too.
German authorities found NDEA in some batches of a related drug:
Click to see if your prescription is on the recall lists:
The FDA has not recalled all batches of Valsartan or Irbesartan, and has not recalled Losartan. The contamination is in some batches that were manufactured in China and India, and that are in some cases labeled under the names of their US suppliers. Valsartan and Irbesartan are generics, and the brand name versions (Diovan and Avapro) have not been recalled. Here is the list of Valsartan products that the FDA has not recalled.
3. What is the timeline of Valsartan recalls?
It appears that since 2012, Chinese drug maker ZHP has been selling Valsartan contaminated with carcinogens. It wasn't until 2018 that the contamination was discovered and announced by authorities in the US and Europe, ultimately leading to worldwide recalls of contaminated Valsartan. Here is a timeline of the recalls:
- July 5, 2018: European countries begin recalling contaminated Valsartan as the European Medicines Agency (EMA), which is like the FDA in Europe, announced a review of Valsartan manufactured by ZHP in China and distributed throughout Europe, because some batches of the drug were found to contain carcinogen NDMA.
- July 13, 2018: The FDA recalled drugs containing contaminated Valsartan. The FDA noted that “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.”
- August 2, 2018: The FDA published updated lists of hundreds of specific US products included in the Valsartan recall.
- August 9, 2018: The FDA cited drugmaker Hetero Labs Limited of India, marketing under the Camber Pharmaceuticals label, as an additional source of the contamination. The FDA noted that Hetero uses a similar manufacturing process to ZHP which manufactured other batches of contaminated Valsartan.
- September 13, 2018: The FDA announced that retesting revealed a second carcinogen, N-Nitrosodiethylamine (NDEA), in the recalled products made by ZHP and marketed in the US under the Torrent Pharmaceuticals (India) brand.
- September 21, 2018: The European Medicines Agency announced it will review four other drugs related to Valsartan: Candesartan, Irbesartan, Losartan, and Olmesartan. The EMA announced this review because German authorities discovered carcinogen NDEA in a batch of Losartan made by Hetero Labs in India.
- September 28, 2018: The FDA banned drug maker ZHP of China from importing any more Valsartan or other drugs into the US. The FDA stated that the ban is to protect patients and that the company needs to figure out how to make sure its manufacturing process is safe. Also, the FDA added that the ban follows its inspection of ZHP facilities on several dates beginning on July 23, 2018, through August 3, 2018, where it found many violations including inconsistent manufacturing process, lack of written procedures, inadequate cleaning, and equipment repair problems.
- October 26, 2018: The FDA announced a recall of some batches of related drug Irbesartan, generic of the brand-name drug Avapro, also used to treat high blood pressure, due to detection of NDEA. These batches were manufactured by Aurobindo Pharma Limited, which is based in India and which supplied the batches to ScieGen Pharmaceuticals. This is the first non-Valsartan drug that the FDA has found to contain NDEA. Here is the list of recalled Irbesartan products. The FDA cited Aurobindo for quality and contamination issues in another context earlier in 2018.
Call us for help...
If you or a loved one is seeking to file a lawsuit for injuries stemming from Valsartan or Irbesartan, please contact us at Shouse Law.