Several drug companies have voluntarily recalled their blood pressure and heart medication containing valsartan. Researchers discovered that the drug could be contaminated with The impurity, N-nitrosodimethylamine or NDMA. NDMA can cause cancer. If you developed cancer from using valsartan, keep your medication. Testing your medication for NDMA can help prove if manufacturers are responsible for your cancer.
Manufactured by Major Pharamascetucials, Teva Pharmaceuticals, and other companies, valsartan is a cardiovascular drug to treat high blood pressure or hypertension. The FDA approved the medication in adults and children aged 6 and up. The drug can also treat adults for heart failure along with reducing the risk of death in those who recently had a heart attack. It is available as a stand-alone medication or as valsartan HCTZ, which combines valsartan with the diuretic hydrochlorothiazide. Common medications containing the valsartan are Diovan, Diovan HCT, Exforge, Exforge HCT or Entresto.
After 22 countries recalled valsartan, the FDA began to take notice. In May 2018, the European Medicines Agency announced that investigators found a potentially dangerous impurity in Valsartan medications sourced from Zhejiang Huahai Pharmaceuticals, a Chinese pharmaceutical manufacturer. They identified the substance as N-nitrosodimethylamine or NDMA. Healthcare authorities have classified NDMA as a possible human carcinogen. Researchers use NDMA to cause cancer in animals during cancer studies. Then, Europe began recalling medications potentially tainted with Valsartan along with urging pharmacies to pull the medication from the shelves.
The announcement also suggests that changes in production at the Chinese manufacturing facility caused the NDMA presence. Also, the facility made the changes in 2012. Therefore, the tainted Valsartan could have been on the marketing for several years before the recent discovery. The FDA doesn’t know exactly how the medication became tainted. However, it postulates a combination of conditions contributed. For example, chemicals, processing conditions, and production steps, possibly led to NDMA. But, the FDA does not know for sure.
The U.S. Valsartan Recall
In July 2018, the FDA has asked three manufacturers of generic valsartan medication to voluntarily recall it from the U.S. market. Also, the agency asked pharmacists to return contaminated medications to the manufacturers. Furthermore, the agency is continuing to investigate the NDMA levels to asses cancer risks in those who already ingested the medication. the agency identified 13 other API manufacturers who supply more than 20 drug companies that make valsartan for the U.S. market. We made plans to determine if their products could also contain NDMA. Over 8,000 people received the highest dose of valsaratan medications, and therefore the largest amount of the chemical.
The FDA named the following manufacturers in the recall
Also, it is dangerous to stop abruptly taking medication involved in the valsartan recall. Contact your healthcare provider for more information.
A Second Carcinogen Found
In September 2018, Now, the FDA announced that three additional lots of valsartan drugs made by Torrent Pharmaceuticals contain a second carcinogen, N-Nitrosodiethylamine, or NDEA. Exposure to NEDA can cause liver damage including necrosis of the liver. It hasn’t been tested in humans, but rats ingesting NDEA had increased fetal mortality rates.
Third Carcinogen Revealed
NMBA (N-Nitroso N-Methyl 4-aminobutyric acid) is a chemical compound that studies have linked to cancer. PubChem showed NMBA exposure caused bladder cancer in rats. The levels FDA investigators discovered are less than the doses in the experiment. However, any dose could potentially cause cancer in humans. This is the second cancer threat. Recalls of losartan, valsartan, and irbesartan started in July 2018. Previously, the only carcinogen identified was NDEA.
Third Heart Medication Recall
The FDA’s newest heart medication recall involves Sandoz’ losartan potassium hydrochlorothiazide. The agency found NDEA in certain lots of the medication. Several pills that contain valsartan, another drug used by heart patients, have been under a recall since July. The drugs were tainted with NDEA or NDMA. Both are carcinogens. The FDA is testing all heart drugs (ARBs) for these impurities.
Furthermore, the losartan recall only involves the 100 milligram/25 milligram tablets. It does not involve the other versions of the drug, sometimes sold under the brand names Hyzaar. The bottle lot number is JB8912. If you have the recalled medication, please keep your medication for testing.
Center for Drug Evaluation and Research estimates over 8,000 people could have ingested the contaminated medication. NDMA and NDEA can cause cancer at very low levels. It is so dangerous that researchers can’t safely test the substance in human studies. However, animal studies show that NDMA and NDEA cause cancer within a year of ingestion.
People who have consumed the carcinogenic medication for at least 180 days experienced these cancers from 2015 onward:
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury because of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect others from needless distress.
We Want to Help Victims
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with medications, and it is the responsibility of manufacturers to provide this information. If you developed cancer after taking a Valsartan medication, you should demand accountability from Sanofi Genzyme.
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You also may be entitled to compensation for their injuries and damages. The types of losses we can help you recover include:
Past and future medical expenses
Loss of an ability to work; and Pain and suffering
If a person dies from complications from a drug, family members may also be able to recover damages for the wrongful death of their loved one, including:
Medical expenses prior to death
Loss of economic support; and
Loss of companionship
Therefore, if a jury finds the conduct of a company to be highly reckless, they may award punitive damages to punish the company and deter similar conduct in the future. If you developed cancer after taking a Valsartan medication, please speak to us to learn more about your rights.