The FDA has expanded a widespread recall of common blood pressure and heart failure medications including losartan. The agency has identified a new impurity and potential losartan carcinogen. The impurity, N-Nitroso-N-methyl-4-aminobutyric acid or NMBA could cause cancer in humans as well as animals.
About NMBA
NMBA (N-Nitroso N-Methyl 4-amino butyric acid) is different than NDEA (N-nitrosodiethylamine) or NDMA, which have been the cause of previous Losartan, Valsartan and Irbesartan recalls. Experts consider NMBA to be a potential cancer-causing ingredient in humans. Now, the FDA has found it inside these medicines’ active ingredient after India-based Hetero Labs Limited manufactured the medication. Those with excess NMBA in their systems are more prone to bladder cancer.
New Losartan Carcinogen
While continuing to test all ARBs for nitrosamine impurities, the FDA found a new impurity, NMBA. Therefore, Camber Pharmaceuticals Inc. recalled 87 lots of losartan tablets in the United States. The recalled tablets, made by Hetero Labs Ltd. in India and distributed by Camber Pharmaceuticals. Thus far, there haven’t been any adverse reports. However, the agency expects this to change.
The recall is the latest in an ongoing investigation into a class of drugs known as angiotensin receptor blockers or ARBs, which contain either valsartan, losartan or irbesartan and are used in patients with high blood pressure and other conditions. Starting in July, the FDA recalled separate lots of ARB blood pressure and heart failure medications due to containing similar impurities that are potential or suspected human carcinogens: N-nitrosodimethylamine or NDMA and N-nitrosodiethylamine or NDEA.
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 2016 onward:
- Liver
- Kidney
- Colorectal
- Stomach
- Bladder
- Pancreatic
Liver injury can also happen within a month of taking valsartan.
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. 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.