Truth Behind the Heart Medication Recalls
In July 2018, the FDA began many heart medication recalls. The government agency discovered after inspections of factories in China and India that the medications contained deadly carcinogens. Americans are scared that the medications desperately needed to live a healthy life could have been unknowingly exposing them to cancer for years.
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 the changes in 2012. Therefore, the tainted valsartan could have been on the 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.
Specific Heart Medication Recalls Involved
The main medications involved in this deadly recall are valsartan, losartan, and irbesartan. Doctors commonly prescribe these blood pressure medications since they effectively block the effects of a hormone that narrows blood vessels. These are normally the first drugs doctors recommend to lower a patient’s blood pressure. Around 103 million American adults have high blood pressure and 36% of this number use medication to treat it. It is unclear how many people on these medications could be exposed to the dangers of this recall.
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.
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, in animal studies NDMA and NDEA cause cancer within a year of ingestion in the:
Liver injury can also happen within a month of taking valsartan.
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. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is also no obligation.