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Third Blood Pressure Medication, Losartan, Recalled
November 13, 2018 - The FDA announced a third blood pressure medication recall because of possible contamination that can cause cancer. Sandoz Inc. is "voluntarily recalling losartan potassium hydrochlorothiazide tablets because the pills could contain an impurity N-nitrosodiethylamine (NDEA)," which is a "probable human carcinogen, according to the International Agency for Research on Cancer." Losartan affected by the recall is 100 milligram/25 milligram tablets with the lot number JB8912.
Valsartan is an off-patent active ingredient in a number of generic drugs, including drugs used to treat hypertension, heart failure, left ventricular failure, and left ventricular dysfunction following myocardial infarction.
Valsartan is also sometimes prescribed with hydrochlorothiazide (HCTZ) to treat hypertension.
Chinese manufacturer Zhejiang Huahai Pharmaceutical first discovered that the generic valsartan products =the company was producing contained impurities, including N-nitrosodimethylamine (NDMA).
Zhejiang Huahai Pharmaceutical supplied these generic drugs containing NDMA to US-based pharmaceutical companies Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. These companies then processed and distributed the drugs to the US market.
NDMA is an organic chemical compound that has been labeled as a probable human carcinogen, according to the International Agency for Research on Cancer (IARC).
NDMA is found in a variety of products ranging from lubricants and softeners to rocket fuel.
NDMA can be produced through chemical reactions that occur in the manufacturing process.
NDMA is the byproduct of the manufacturing of certain pesticides, fish processing, and the production of rubber tires.
NDMA can also be found naturally, in trace amounts in certain foods. NDMA is released in these foods through chemical reactions during the food preparation process. For example, NDMA can be produced by grilling, browning, and salting of certain meats.
Studies on animals have shown NDMA to be a carcinogen, causing cancerous tumors to form on the liver, kidney, and respiratory tract. Liver cancer, gastric cancer, colorectal cancer, kidney cancer, lung cancer, and nasal cancer have all been associated with NDMA, but it appears to be a universal carcinogen, meaning it has the potential to cause cancer in almost all organs. For these reasons, NDMA has been labeled a probable human carcinogen.
NMDA exposure has also been associated with non-cancerous liver damage, according to the US Department of Health and Human Services.
In July 2018, the U.S. Food and Drug Administration (FDA) issued a recall of a number pharmaceutical drugs containing valsartan used to treat hypertension (high blood pressure) and heart failure due to the increased risk of certain cancers associated with NDMA. Not all drugs containing valsartan were named in the recall.
The following were named in the recall:
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
The FDA issued a press release along with the recall announcement – “The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” the FDA release said.
The FDA is now conducting a full-length investigation into the safety of the recalled products.
The FDA stresses the importance that patients DO NOT stop taking the recalled products altogether – the danger of abruptly discontinuing use of this medication greatly outweighs the risks associated with short-term NDMA exposure – patients should rather contact their healthcare provider right away to discuss alternative medication options.
The FDA followed suit of 22 other countries that had previously recalled valsartan products.
Were you prescribed one or more of the following products?
And developed any of the following injuries as a result?
Currently, TorHoerman Law is accepting and signing cases in the Valsartan Lawsuit. If you believe that you may potentially have a claim against Valsartan or similar drugs, please fill out the chat form.
Claims are being investigated against manufacturers and distributors of hypertension medications containing the active ingredient valsartan, which contains the probable human carcinogen N-nitrosodimethylamine (NDMA). Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. sold hypertension and heart failure medication containing valsartan, putting consumers at risk of developing a number of life-threatening cancers.
Any questions? Don’t hesitate to contact us!
July 18, 2018 - Teva Pharmaceuticals USA confirmed a voluntary recall to all consumers/user level of 29 lots of single & 51 lots of combination Actavis valsartan medicines. This includes any products whose active ingredient is valsartan or valsartan and hydrochlorothiazide.
This voluntary recall was issued after trace amounts of N-nitrosodimethylamine (NDMA) were discovered in valsartan products. It should be noted that this recall also follows a mandated recall by the FDA – the agency issued a full recall of all blood pressure and heart failure medication with the active ingredient valsartan or valsartan and hydrochlorothiazide.
May, Ashley. "FDA Recalls Another Blood Pressure Drug for Possible Cancer Risk." USA Today, Gannett Satellite Information Network, 14 Nov. 2018, www.usatoday.com/story/money/nation-now/2018/11/13/fda-losartan-recall-cancer-risk-tied-blood-pressure-drug/1985858002/
Last Modified: May 20th, 2019 @ 07:54 pm
The FDA has begun the process of recalling a number of high blood pressure and heart failure medications containing the active ingredient valsartan, citing the presence of known carcinogenic agent NDMA.
Currently, TorHoerman Law is accepting and signing cases for the Valsartan lawsuit. If you believe that you may potentially have a claim against Valsartan, please contact our office.
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