Valisure Finds Unprecedented Levels of NDMA in Ranitidine Tablets
Online pharmacy company Valisure tests batches of drugs before they sell them to consumers. During its testing, Valisure found unprecedented levels of NDMA in Zantac and other ranitidine tablets.
“Every manufacturer and every type of Zantac or ranitidine that we’ve analyzed seems to have the same problem of the drug itself being very unstable and degrading, or even potentially reacting to, the condition in the human stomach to create NDMA.” – David Light, Valisure CEO
Valisure alerted the FDA to the issue in the summer of 2019 and the FDA issued a statement saying it would investigate the Zantac NDMA link to cancer. In April of 2020, the FDA issued a market withdrawal for Zantac, citing the results of its own testing and evaluation.
The Zantac lawyers at Baum Hedlund Aristei & Goldman believe the FDA’s decision to issue a Zantac market withdrawal is a necessary step toward protecting people from a dangerous drug. More can and should be done, however. Our firm has been calling for a Zantac recall since 2019 because there is no level of NDMA that is safe.
World Health Organization NDMA Zantac Investigation
The International Agency for Cancer Research (IARC), a unit of the World Health Organization, is the most recognized cancer research institution in the world. It brings together teams of scientists from multiple countries to investigate the cancer-causing potential of suspect chemicals and substances and publishes papers known as monographs to report the results.
After studying over 200 research papers on NDMA and the NDMA cancer risk, the IARC placed the chemical in the “Group 2A” category, meaning substances that are “probably carcinogenic to humans.” The agency found that NDMA is “carcinogenic in all animal species tested” and noted that the metabolism of NDMA by humans and animals is similar. NDMA was found to cause malignant tumor growth in multiple organs, in multiple species, by multiple routes of exposure (oral, inhalation, subcutaneous (under the skin), injections), with dose-response relationships appearing in several studies.
“N-nitrosodimethylamine should be regarded for practical purposes as if it were carcinogenic to humans.” – International Agency for Cancer Research, Monograph 17, available online here
International Agency Places NDMA in High Risk Group
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which establishes shared regulatory guidelines for nations worldwide, places NDMA among those chemicals with the highest potential for damaging DNA and causing cancer. The council refers to these chemicals as the “cohort of concern” because they could be associated with cancer risk even at very low exposure levels.
Zantac Cancer Attorneys with a Proven Track Record Against Big Pharma
If you or a family member developed cancer associated with NDMA and Zantac, we can help. The attorneys at Baum Hedlund Aristei & Goldman have decades of experience holding major corporations accountable for concealing the true dangers of their products. Across all areas of practice, the firm has achieved more than $4 billion on behalf of our clients.
Contact us or give us a call at (855) 948-5098 for a free Zantac case review.