Valsartan Cancer Info

What is valsartan?

Valsartan-containing drugs (“VCDs”) are used to treat high blood pressure (hypertension), heart failure, and to improve a patient’s chances of living longer after a heart attack. They belong to a class of medications called angiotensin II receptor blockers (ARBs). In 2018 it was discovered that some generic versions of valsartan manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd., and distributed in the United States by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.; and Solco Healthcare, contained impurities as a result of poor manufacturing processes. Once the contamination was public the companies either recklessly or intentionally minimized and downplayed the known and documented risks of serious side effects.

More than Valsartan

The concern over impurities for this class of medications has now expanded to also include additional generic medications, losartan and irbesartan. The contaminants have only been found in some generic products. Currently there are three main impurities of concern, N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), or N-Nitroso N-Methyl 4-amino butyric acid (NMBA). These contaminated drugs were designed, manufactured, marketed, distributed, packaged, and sold as legitimate, for profit. Some patients who took them as prescribed have developed bladder and other cancers, leukemia, non-Hodgkin’s lymphoma, or multiple myeloma.  

How did the drug get contaminated?

The contaminants developed due to a known chemical process in the manufacturing of the drug, and manufacturers failed to check for these known possible contaminants. Because NDMA, NDEA, or NMBA were not disclosed as ingredients they would be considered misbranded medications. It is unlawful to introduce a misbranded drug into interstate commerce.  

What you should do

• The FDA has advised patients to “continue taking your current medicine until your doctor or pharmacists gives you a replacement or a different treatment option. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. Untreated heart failure increases the risk of hospitalization and death.”

• If you have taken valsartan and been diagnosed with cancer, you may be eligible to pursue compensation.

  • Call Toll Free: 800-331-2782 or 212-687-8181 or complete the form online: Contact us.

 The FDA relies on generic-drug manufacturers to give them accurate data, but not every company has - something the agency calls a "data integrity" problem. Here's what one data integrity industry expert who has done hundred’s of drug-manufacturing audits said:

“It is not unique to any one company. It's something that the entire industry is struggling with.”

George Toscano, a dats integrity expert at consulting firm NSF International

READ MORE

Find out which specific blood pressure medications are affected by the recall

FDA has worked with manufacturers to swiftly remove angiotensin II receptor blocker (ARB) drug products with impurity levels above interim acceptable limits. Those products have been removed from the market and have been posted in this recall lists for ARB products.

Timeline

1996: Novartis debuts Diovan (valsartan), approved as an angiotensin II receptor blockers (ARBs) to treat high blood pressure.

March, 1998: Diovan HCT was approved for second-line treatment of hypertension. Diovan HCT is a combination of Diovan, an angiotensin II receptor blocker (ARB), and HTC a diuretic.

September 2012: Diovan lost its patent, Mylan Phamaceutical develops generic drug for Diovan HCT.

June, 2014: Ranbaxy Laboratories announced that its subsidiary, US-based Ohm Laboratories (Ohm), had received the first approval from the US Food and Drug Administration (FDA) for generic valsartan.

September, 2014: Guidance for the control of mutagenic impurities (ICH M72) in drug manufacturing was introduced. This guideline outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in the final product. The threshold of toxicological concern (TTC) was defined as the value of lifetime cancer risk deemed to be acceptable. However, some structural groups were deemed to be of such high carcinogenic potency that even intakes below the TTC would still be associated with a potential for a significant carcinogenic risk. This group of high potency mutagenic carcinogens was referred to as the “cohort of concern” and included N-nitroso-, such as included NMDA and NDEA.

July, 2018: European Medicines Agency announced it had detected an impurity in valsartan supplied by Zhejianjg Huahai, (N-nitrosodimethylamine; NDMA) that formed as a result of a change in the manufacturing process. The Food and Drug Administration announced a recall of certain batches of valsartan-containing drugs after finding NDMA in the recalled product. The FDA warning letter suggests that the formation of the impurities could have been uncovered and resolved at least two years earlier.

August 2018: Valsartan drug substance from 16 different suppliers to the US market had been implicated.

September, 2018: The European Medicines Agency reported that another impurity, N-Nitrosodiethylamine (NDEA).

October, 2018: FDA posted the results of testing conducted on samples of recalled valsartan tablets. The results showed levels were between 3.1 and 208.3 times the level of NDMA deemed safe for human consumption. The manufactuer failed to conduct proper testing.

Fall, 2018: The FDA noted that manufacturers are responsible for developing and using suitable methods to detect impurities, including when they make changes to their manufacturing processes.

January, 2019: Prinston Pharmaceuticals recalled one lot of irbesartan tablets and seven lots of irbesartan HCTZ tablets because it contained unacceptable levels of the probable carcinogen nitrosodiethylamine (NDEA)

February, 2019: The FDA posts interim iimits for NDMA, NDEA, and N-Methylnitrosobutyric acid (NMBA) in Angiotensin II Receptor Blockers (ARBs).

March 12, 2019: The FDA approved new generic forms of Diovan, the drug that contains valsartan, to mitigate shortages.

September, 2019: Torrent Pharmaceuticals Limited is expanding its recall for losartan that contain NMBA above the acceptable daily intake.

November, 2019: The FDA announced a voluntary recall of losartan containing products from Torrent Pharmaceuticals. In February several additional pharmaceutical companies recalled losartan containing products.