Merck, manufacturer of the popular blood pressure medication Valsartan has recalled over 3500 products due to a potential risk they may contain an impurity. The recall includes both prescription and non-prescription medications that have been manufactured in China since May 2014.
The “valsartan lawsuit update 2021” is a legal case in which the FDA has recalled valsartan. The recall was due to an increased risk of cancer and heart problems.
What is Valsartan and how does it work?
Various generic manufacturers, such as Major Pharmaceuticals, Mylan Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals, Torrent Pharmaceuticals, and others, make and sell Valsartan, a blood pressure medicine.
The Food and Drug Administration (FDA) has authorized Valsartan as a therapy for high blood pressure in adults and children aged six and above. It’s also authorized for treating heart failure and lowering the risk of mortality in those who have suffered a heart attack lately.
Angiotensin II receptor agonists, such as valsartan, are a kind of hypertension medicine. These medications open up blood arteries, enabling blood to flow more freely.
Valsartan is available as a standalone medicine or in a combination with the diuretic hydrochlorothiazide, known as valsartan HCTZ.
This does not imply that the drugs themselves are cancerous. What that means is that the components in these medicines, which are almost always produced in China and India, have been tainted with a carcinogenic chemical.
Since the problem was identified in 2018, recalls of the impacted goods have been issued.
What exactly is NDMA?
NDMA stands for N-Nitrosodimethylamine and belongs to the “nitrosamine” family of compounds.
Because NDMA is present in smoked meats and other foods, almost everyone has been exposed to it in tiny quantities. NDMA is also a result of a number of industrial operations, which seems to be the source of the drug contamination.
In large enough doses, NDMA may induce kidney cancer and other cancers.
How Did Valsartan Become NDMA-Contaminated?
Changes in the production process for sartan medicines were discovered during an FDA examination of a pharmaceutical manufacturing facility in Linhai, China. The goal was to minimize waste and increase efficiency, but the outcome was an unanticipated chemical reaction that resulted in the creation of NDMA.
Another source of contamination has been identified as a plant in Hyderabad, India, where the sartan used in ARB medicines is sourced by three major pharmaceutical firms (Torrent, Mylan, and Teva). The FDA gave the plant a warning in 2017 for failing to supervise the production process and guarantee product quality control.
Recall of Valsartan
A potentially hazardous contaminant in valsartan medicine supplied from Zhejiang Huahai Pharmaceuticals, a Chinese pharmaceutical company, was identified in May 2018, according to the European Medicines Agency.
N-nitrosodimethylamine, or NDMA, is an impurity discovered in valsartan. NDMA is categorized as a “probable human carcinogen” (a chemical that may cause cancer) by many health agencies.
National authorities throughout Europe started recalling medicines containing possibly contaminated valsartan in an attempt to safeguard patients from the danger of valsartan cancer. The United Kingdom’s health authorities followed suit, asking pharmacists to remove valsartan and valsartan HCTZ off their shelves.
The FDA stated in July 2018 that it has requested three makers of generic valsartan medicine to voluntarily withdraw it from the market in the United States. Pharmacists are being urged to remove the recalled drugs from their shelves and return them to the makers.
The presence of NDMA in valsartan medicine was caused by modifications in the way it was manufactured at a manufacturing plant in China, according to the UK’s Medicines and Healthcare Products Regulatory Agency. These modifications were performed in 2012, implying that contaminated valsartan has been on the market for some time.
The FDA is investigating the amounts of NDMA in valsartan medicine, determining the risk of valsartan cancer patients, and determining what measures should be done to minimize or remove NDMA from future batches of valsartan manufactured by Zhejiang Huahai Pharmaceuticals.
Some valsartan medicines have been recalled, but not all. The voluntary valsartan recall affects valsartan and valsartan hydrochlorothiazide (valsartan HCTZ) manufactured or marketed by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries. The FDA has information on the items that have been impacted by the valsartan recall.
Valsartan batches are still being recalled in 2019.
Patients who are using a recalled drug should keep taking it until a substitute is available, according to the FDA, since the diseases that valsartan treats are severe. Patients should talk to their doctors about discontinuing valsartan and switching to an alternate therapy or an other valsartan drug that isn’t affected by the recall.
The “losartan lawsuit payout” is a class-action lawsuit filed against the manufacturer of losartan, Teva Pharmaceuticals. The case was filed because of the drug’s potential to cause serious side effects.
Frequently Asked Questions
Is there a class action suit against Valsartan?
A: Yes, there is a class action suit against Valsartan.
How do I know if my Valsartan has been recalled?
A: If you are unsure whether your Valsartan has been recalled, please contact the manufacturer for more information.
Which Valsartan has been recalled?
A: The Valsartan that has been recalled is manufactured by Merck.
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