How Does Valsartan Affect the Body?
Batches of Valsartan manufactured in China resulted in errors that resulted in residual solvents which formed NDMA and NDEA (N-Nitrosodimethylamine) in Valsartan pills. NDMA and NDEA are known to be carcinogens to humans (meaning, these chemicals are known to cause cancer in people, under certain circumstances). The failure of the manufacturing process in China included not testing for residual solvents, which allowed these products to be sold to consumers in the United States. This defective manufacturing process lead to “mutagenic impurities created in the manufacturing process,” which ultimately led to individuals taking impure medications that put them at risk of developing cancer.
Why is this so toxic?
NDMA and NDEA exposure may result in two genetic changes in humans that can lead to the development of cancer. In the P53 gene, the NDMA “turns off the switch” to the P53 gene to kill itself, therefore the body is unable to prevent cancer from developing. Essentially, the ingestion of the NDMA at the doses prescribed, may put individuals at a significantly increased risk of developing cancer.
What does the FDA say about Valsartan?
As of May 6th, 2019, the FDA is alerting patients and health care professionals to a voluntary recall of 19 lots of losartan potassium tablets made by Vivimed Life Sciences Pvt Ltd in Alathur, Chennai, India and distributed by Heritage Pharmaceuticals Inc, East Brunswick, New Jersey, due to the detection of the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Vivimed is recalling lots of losartan-containing medication that tested positive for NMBA above 9.82 parts per million.
FDA reminds patients taking recalled angiotensin II receptor blockers (ARBs) to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.
The Attorney’s at McCallister Law Group provide Valsartan Litigation Representation in Chicago Illinois for Victims who are suffering from cancer and were prescribed Valsartan between 2016 and 2018. McCallister Law Group is committed to helping victims of Valsartan medical concerns and are ready to provide you with the support you need. If you need help finding medical assistance for your cancer treatment related to this recalled prescription drug, do not hesitate to contact the McCallister Law Group now.
Additional Information about Valsartin
Valsartan is the largest Class I recall ever where consumers have received direct notice.
The active ingredient is the same across all Valsartan drugs and 95% of the patients taking the drug are taking either a 160mg or a 320mg dose. In the medications that were contaminated, it is believed that the higher the dosage an individual was taking, the greater the ingestion of carcinogen that contaminated the Valsartan.
A patient does not have to have received a recall notice in order to have a viable claim.
There are approximately 3 million users of Valsartan, and a significant number of these individuals may have been taking contaminated medication.
Contamination has been speculative to have occurred since 2012, and in the U.S. domestic market since as early as 2014. The domestic imports from Asia dramatically increased in 2016, after which it is believed that most U.S.-based individuals would have been exposed to the contaminated Valsartan.
The Chinese API manufacturers have worked for years with U.S. manufacturers, and the Chinese sent the ingredients to U.S. manufacturers who have the legal obligation to make sure the drug is pure and is bioequivalent. The drug is not pure or bioequivalent if it is adulterated, or if there is a manufacturing defect resulting in the medication being contaminated with carcinogens.
From a legal standpoint, there is a non-delegable duty of American manufacturers to ensure the safety of the API into the drug for consumption. Each of the defendants in the chain of distribution may have this obligation to ensure the purity of the drug.
Contact McCallister Law Group, LLC for a free, confidential case evaluation using the form provided or by calling (888) 293-4952.