The FDA released another alert about their investigation into the carcinogens recently uncovered in valsartan, Losartan and irbesartan medications. In typical FDA fashion, the commissioner said that the agency is still investigating but described the impact as small. This is very dismissive to the thousands of people who may have cancer due to their slip up in the first place.

Uncovering the Carcinogen

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 changes in 2012. Therefore, the tainted valsartan could have been on marketing for several years before the recent discovery. FDA inspectors found equipment had fraying gaskets, rusted screws and missing pieces and discovered workers repeatedly failed to investigate testing anomalies in drug batches.

Still, factory operations continued until testing in June revealed unacceptable levels of NDMA. The FDA announced a recall in July, and testing found NDEA in valsartan batches. It wasn’t just issues in China. At a Hetero Labs plant in Jadcherla, India, workers shred documents before inspectors arrived in 2016. The FDA warned the drugmaker that it failed to investigate discrepancies in drug batches and didn’t regularly clean equipment to prevent contamination. Now, multiple medications are contaminated, and the FDA is dismissive.

FDA Dismal Announcement

The FDA said in the announcement that the agency was concerned with the impurities in the heart medication. Therefore, the agency employed a team of chemists, toxicologists, physicians, pharmacists, communication specialists, investigators and analytical laboratory staff from across the FDA and in collaboration with global regulators. This team developed testing methods specifically designed to detect and quantify the NDMA and NDEA in all ARB medicines. These three specific tests are (GC/MS) headspace method, the combined headspace method, and the combined direct injection method. These testing methods can be used for evaluating both drug substances (API) and finished drug products.

However, even with the information provided about trying to identify the carcinogens, the FDA was dismissive of the injuries. In fact, the agency said the impact should be small. Small? One consumer developing cancer due to ingesting this medication should not be dismissed. There are thousands of pills filled with carcinogens on the shelf for years without notice. But, the FDA is not concerned. That is a serious issue. An issue that American consumers should demand accountability for.

Seek Justice

Many people after taking recalled heart medications are horrified to learn that their blood pressure meds could have caused their liver cancer. Thus, it is important to seek justice. These potentially cancer-causing drugs have been on the market for over 5 years. This is unacceptable. Therefore, 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. You could receive compensation for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is also no obligation.