Wednesday, April 22, 2020 - A small corner of the pharmaceutical market has been turned on end with the discovery that potentially unsafe levels of N-nitrosodimethylamine, or NDMA, have been found in some of the most widely prescribed prescription and over-the-counter medications in the country. NDMA has been classified as a probable carcinogen because, although ethical testing cannot be done in humans, it has been shown to cause cancer in animals.
The discovery of high levels of NDMA in ranitidine, the active ingredient in Zantac, has led to a massive recall of the drug. Drugs containing valsartan, used to treat high blood pressure and heart failure, and nizatidine, used to treat peptic ulcers and other stomach acid-related conditions, have faced limited recalls after FDA testing verified some high levels of the probable carcinogen.
A fourth medication, metformin, an oral diabetes medication, was found by some independent laboratory tests to contain high levels of the drug, but FDA testing did not concur. It has not been recalled.
Other drugs may also be culprits, as researchers and watchdog groups continue to find the dangerous chemical in drugs previously thought to be safe.
What is NDMA?
NDMA is a chemical compound found in low levels in many of the foods we eat, including roasted meats, barbecue, cheese, and beer. It is the result of a chemical reaction that occurs in the cooking process, and in most cases, the amount of NDMA found in these foods is not harmful.
The problem comes in when NDMA is found in higher levels in medications that are taken every day, sometimes multiple times a day. This frequent exposure to high levels of NDMA are believed by many experts to cause stomach and other gastrointestinal cancers.
To complicate matters, researchers are still unsure of the effects heat and time have on drugs that contain NDMA. Some studies, including the FDA's latest study of Zantac, show that NDMA is produced as the drug decomposes. Other studies suggest that heat produced by the body during the digestion process creates a process in which potentially high levels of NDMA are released.
Since studies conducted by the FDA have not used body temperature heat in the past, this possibility is still being explored. Valisure, an independent online pharmaceutical company whose laboratory testing first identified high levels of NDMA in ranitidine, issued a citizen's petition to the FDA stating, "Combined with other data from Valisure and the scientific works of Stanford University and others, the evidence presented shows this instability and the resulting NDMA occurs in the conditions representative of those in the human body and builds a compelling case for ranitidine being a likely human carcinogen." Those conditions, as outlined in the petition, include body-level temperatures not tested in FDA labs.
Tens of millions of people take medications that have been found in laboratories outside of the FDA to contain levels of NDMA higher than the government-recommended daily allowance. As research begins to become more conclusive, it is becoming increasingly evident that these drugs are likely linked to gastrointestinal cancers.
The personal injury attorneys at OnderLaw are holding corporations accountable for putting profits over people, and we work hard to ensure that the drugs our families and neighbors rely on are safe.
If you or someone you love has taken ranitidine (Zantac), valsartan, or nizatidine regularly and has been subsequently diagnosed with stomach or other gastrointestinal cancers, contact the experienced personal injury and wrongful death attorneys at OnderLaw at 1-800-RxWatch. We don't get paid unless you win your case, and we will fight for you.
OnderLaw, LLC in St. Louis has developed a solid reputation of excellence as a personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation, including Pradaxa, Lexapro and Yasmin/Yaz, Actos, Risperdal and others. The Onder Law Firm has won verdicts of more than $300 million in talcum powder ovarian cancer lawsuits and represent more Glyphosate victims than any other firm in the country.