This year thousands of American consumers are shocked to learn that their heart medication could have caused their cancer as multiple recalls keep occurring. However, what happened at Zhejiang Huahai Pharmaceutical could easily not only happen again, but it is possible to happen in the United States, too.
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.
Valsartan Cancer Recall
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. 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 valsartan medications, and therefore the largest amount of the chemical.
The FDA named the following manufacturers in the recall
- Major Pharmaceuticals valsartan products
- Solco Healthcare valsartan products
- Teva Pharmaceuticals Industries Ltd. valsartan products
- Solco Healthcare valsartan/HCTZ products
- Teva Pharmaceuticals Industries Ltd. valsartan/HCTZ products
Heart Medication Cancer Could Repeat
The FDA released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China. The letter outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control and cross-contamination from one manufacturing process line to another. However, the agency does not know the exact source.
This manufacturer error could not only happen again, but chances are it could happen here, too. In fact, it already has. Drug manufacturer Sanofi Genzyme recalled thousands of Synvisc-One injections after microbial contamination. Another company had to stop manufacturing children’s Tylenol after its manufacturing process deposited metal specks in the pain product. Then, in 2011, Baxter Healthcare discovered endotoxins, a harmful substance released by dead bacteria, was in its kidney dialysis medication. The bacteria contaminated the medication through cracks in the manufacturing tanks.
These are just a small blip of the thousands of manufacturing errors that cause consumers serious harm. Therefore, an NDEA or NDMA contamination here isn’t too far-fetched to imagine.
Many people after taking valsartan are horrified to learn that their medication could have caused their cancer. Therefore, it is important to seek justice. These potentially cancer-causing drugs have been on the market for over 5 years. This is unacceptable. You should hold these manufacturers accountable.
We want to help send a message that this is not acceptable. If a dangerous product harmed you, we will be your advocate. Additionally, 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.