On the 13th of September 2019, the United States Food and Drug Administration (FDA) recalled many over-the-counter (OTC) prescriptions because they believed the drugs were contaminated. The source of this contamination is a carcinogenic substance referred to as N-Nitrosodimethylamine (NDMA). NDMA is especially common in ranitidine and is believed to be the cause of cancer in some patients. The chemical is an environmental contaminant found in water and foods like vegetables, dairy products, and grilled meats. Ranitidine, also known as Zantac, is a heartburn medication in histamine-2 blockers sold by a company called Sanofi.
The Environmental Protection Agency classifies NDMA as a carcinogen because it damages the DNA. Studies conducted on animals show that NDMA drugs have the risk of inducing cancerous tumors in the liver, respiratory tract, and kidney. The NDMA found in medications also causes cirrhosis and hyperplastic nodules in monkeys. These findings have, thus, classified the chemical as a possible carcinogen in humans.
Dr. Barry Sears is a leading authority in anti-inflammatory nutrition, president of the non-profit Inflammation Research Foundation, and author of the Zone Diet book series, including his newest release, The Resolution Zone. With regards to its effects on humans, Dr. Barry Sears notes, “NDMA is not the root cause of cancer in humans, instead, it is a possible carcinogen. However, the dose will determine the amount of poison as taken by the patient.”
Like Sears, the FDA has determined that increased and unacceptable levels of NDMA in medications are a cause for concern since it poses a danger to patients’ health.
Medications That Contain NDMA
Ranitidine is an OTC medication that contains NDMA. Ranitidine is made and produced by a company called Sanofi. The generic version of the OTC drug ranitidine is made and sold by a company called Sandoz in the United States. Ranitidine is the primary OTC sold in the market that’s known to have NDMA. This is a common acid-reducing medication prescribed to adults, babies, and the elderly. Many companies practice the art of selling generic versions of prescription products and OTC medication. Ranitidine’s generic version is widely sold in the U.S.
Another medication that contains NDMA is Valsartan. Valsartan is a medicine manufactured in China by the Zhejiang Huahai Pharmaceuticals, which was commonly used in the European Union. After the European Medicines Agency (EMA) discovered NDMA in medicine in 2018, Valsartan was recalled in all European Union countries. The FDA then called for a voluntary recall of other Valsartan products manufactured in China and India, by Mylan Pharmaceuticals, in the same year.
Cancer As An Effect On Ranitidine Patients
Stanford studies speculate that enzymes in the human body react with ranitidine to create the NDMA compound. As mentioned, NDMA causes cancer in several animal species. Nevertheless, determining the exact amount of NDMA that can cause cancer is challenging. It’s accepted that in every 100,000 ranitidine subjects, one person is bound to have cancer. However, 12 are bound to get cancer in the same study group if they were on Valsartan, according to the European Medicines Agency’s assessment. But the results are dependent on the number of years the patient has been on the medication.
The level of exposure to NDMA is another determining factor. Since Ranitidine and Zantac have been in use since 1981, the risk of getting cancer is higher. Ranitidine is the 50th most prescribed medication in the U.S.A. Take into account that NDMA contents in ranitidine are greater than the daily intake limit: 96 nanograms. Also, people who take the medication have an increased level of NDMA in their urine, which indicates that the risk of cancer may be significant.
Effects Of NDMA In The Stomach
The effects of consumed NDMA in the body usually starts in the acidic aqueous solution in the stomach. When the drug is in the gastric fluid, it converts the nitrates ingested from foods into nitrites. Foods rich in nitrate include spinach, beets, lettuce, and celery. Alone, these foods are nutritious, but when consumed with NDMA, the health benefits of these foods don’t outweigh the risks. This is because NDMA in foods on average amounts to one microgram every day and the recommended daily intake is 96 nanograms. Thus, eating these particular foods while taking NDMA might increase the risk of cancer because of the daily overdose intake of NDMA content.
Nevertheless, the sources of NDMA, whether from foods, the environment, or medication, are many. A study done by the Memorial Sloan Kettering Cancer Center showed that ranitidine increased the odds of contracting testicular, breast, kidney, and thyroid cancer. The chemical compounds in NDMA seem to promote underlying hepatic damage conditions. For patients taking ranitidine, valsartan, and related medications, the potential effects of carcinogenic risk seem eminent.
Public Outcry Over NDMA Drugs
The widespread use of ranitidine means that many people, including small children, are facing the risk of harboring cancerous cells in their bodies. Thus, as soon as the information about NDMA became public, people raised concerns regarding their risks of cancer exposure. One significant concern is the fact that ranitidine has been in the market for about 40 years. This means that the levels of NDMA in patients’ bodies might be higher than people expect. Another imploring public concern is knowing whether an individual is affected or not, and whether taking the medications should immediately cease.
Some U.S. citizens have been trying to come up with ways that push Big Pharma and the government to guarantee their safety. Valisure, an online pharmacy and laboratory company, went as far as submitting a petition requiring the recall and safe destruction of all ranitidine medication. Valisure CEO, David Light, was quick to mention that the risk of cancer for a widely used drug was unacceptable.
Big Pharma And Government Response
Many academics are now focusing on the potential sources of NDMA. Pharma companies are now on high alert to test their medication. Additionally, information is being provided to the public concerning the possible health effects of overexposure to NDMA. Some of these effects include nausea, vomiting, dizziness, jaundice, fever, and abdominal cramps. Anyone who uses a medication that contains NDMA while also experiencing any of those symptoms should consult a doctor.
It’s vital to note that close to 40 percent of the United States’ medication is manufactured overseas. Also, 80 percent of the U.S. ingredients used to make the medicine are imported from China and India. Therefore, it’s speculated that the rise in NDMA could result from changes in the manufacturing process over the years. This makes it challenging for the FDA to control the quality of medication used in the nation.
Sanofi, the company that sells Zantac did not halt sales in response to public claims. In a statement, the company declared that the levels of NDMA in the prescription medication Zantac, as reported by the FDA, was not enough to warrant a recall. On the other hand, Sandoz halted the production and distribution of its generic counterpart and later instituted a recall. The FDA is taking steps to ensure that the NDMA sources are eliminated.
NDMA has the potential to cause cancer in humans. Despite the panic and fear brought forth by the NDMA findings, ranitidine users should remember that there are effective and safe alternatives in the market. The FDA, the government, and the pharma industry should also stay vigilant and take steps to determine the source of NDMA and the best ways to combat its risks.
Elton was first a general writer. But after battling a weight management problem, he became passionate about living a healthy lifestyle. Now he works out 5 times a week, lives off keto, and writes about health.