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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.
TorHoerman Law is currently 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.
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 classified as an angiotensin receptor blocker (ARB). Valsartan works by relaxing blood vessels, allowing blood to flow more easily.
Valsartan is also sometimes prescribed with hydrochlorothiazide (HCTZ) to treat hypertension.
Chinese manufacturer Zhejiang Huahai Pharmaceutical first discovered that the generic valsartan products that 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.
Based on lab testing, NDMA is classified as a probable human carcinogen. NDMA is found naturally and at low levels in water and foods such as meats, dairy, and vegetables.
Extremely small levels of NDMA found in foods are not harmful. However, higher levels of NDMA are associated with an increased risk of a number of serious cancers and liver damage.
NDMA contamination in valsartan is high enough that it has sparked major concern from manufacturers, federal oversite institutions, and consumers. While NDMA has not yet been labeled a known human carcinogen, it is still likely to be dangerous to humans.
Valsartan is difficult to metabolize, often causing stress on the liver. Valsartan has been linked to an increased risk of developing kidney cancer. This is due to the presence of NDMA, which is a probable carcinogen found in valsartan.
Valsartan can cause liver damage. Valsartan also increases the risk of developing liver cancer.
Both Valsartan and Losartan are classified as angiotensin receptor blockers (ARBS). Although they have the same classification, losartan and valsartan are not the same. There are a number of notable differences, including dosage, length of effectiveness, and uses.
In July 2018, the U.S. Food and Drug Administration (FDA) issued a recall of a number of 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 the 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.
22 other countries that had previously recalled valsartan products prior to the FDA valsartan recall.
Were you prescribed one or more of the following products?
And developed any of the following injuries as a result?
If so, you may be eligible to participate in a valsartan lawsuit. You should contact an experienced valsartan injury lawyer right away to discuss the specifics of your case.
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.
If you or a loved one believe that you have suffered an injury as a result of NDMA in valsartan, you may be eligible to participate in a valsartan lawsuit. Contact a valsartan injury lawyer today to determine whether you qualify for a valsartan lawsuit.
You should begin to collect evidence as soon as possible following your injury. Familiarize yourself with the steps of civil litigation, so that you are aware of the process of a valsartan lawsuit. Then, you should hire a personal injury attorney, preferably a valsartan injury lawyer.
It is important that you seek proper medical treatment, follow your doctor’s orders, and mitigate injuries and future problems.
Do not hesitate to contact a valsartan injury lawyer – your state’s statute of limitations limits the amount of time you have to file a valsartan lawsuit, so you should begin the process as soon as possible.
Your valsartan injury lawyer will be able to assess damages for your case to determine the amount of compensation you should demand from the defendant. Liability in a valsartan lawsuit depends on the company and manufacturers where the drugs containing valsartan originated from – your valsartan injury lawyer will be able to determine which parties are liable. In many valsartan lawsuits, plaintiffs will decide to file both compensatory damages and punitive damages against the defendant.
Once you have mitigated injuries, began collecting evidence, assessed damages, determined the liable party, and hired a valsartan injury lawyer, you can file your valsartan lawsuit.
Filing a bad drug lawsuit can be a complex process. An experienced valsartan injury lawyer can help you navigate this complex process and ensure that you recover your full losses in your valsartan lawsuit.
At TorHoerman Law, we offer free no-obligation case consultations with all potential valsartan lawsuit clients. So, call today to discuss your case with a valsartan injury lawyer today.
All TorHoerman Law valsartan injury lawyers work on a contingency fee basis. So, we are just as dedicated as our clients to getting the best possible outcome for all of our valsartan lawsuit plaintiffs.
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.
“Valsartan (Oral Route) Description and Brand Names.” Mayo Clinic, Mayo Foundation for Medical Education and Research, 1 Dec. 2019, www.mayoclinic.org/drugs-supplements/valsartan-oral-route/description/drg-20067355.
“Valsartan Oral : Uses, Side Effects, Interactions, Pictures, Warnings & Dosing.” WebMD, WebMD, www.webmd.com/drugs/2/drug-849/valsartan-oral/details.
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: January 20th, 2020 @ 03:18 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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