HWN Suggests

Zantac unlikely to turn into cancer-causing chemical in the body, but concerns remain about how drugs age on the shelf

When consumers get a prescription drug from the pharmacy, they assume that it’s been tested and is safe to use. But what if a drug changes in harmful ways as it sits on the shelf or in the body?

One dangerous result has been the creation of N-nitrosodimethylamine (NDMA), a probable carcinogen, in certain drugs. NDMA is found in chlorinated water, food and drugs in trace amounts. To minimize exposure, the U.S. Food and Drug Administration has set an acceptable level of NDMA in each pill at less than 96 nanograms.

But over the past few years, the FDA has found excessive amounts of NDMA in several drugs for hypertension, diabetes and heartburn. As a result, the agency has…

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Articles of Interest

Toxicological Profile for N-Nitrosodimethylamine (NDMA)

N-Nitrosodimethylamine (NDMA) is a volatile nitrosamine that occurs widely in the environment due to its ready formation from commonly found precursors. NDMA is the most well-studied of several volatile N-nitrosamines that exhibit similar toxic properties (including several others that are found in tobacco smoke). For most people, the largest source of exposure to NDMA is through endogenous production (within the body) from precursors (presence of nitrite in foods including drinking water) that occur naturally in the body or in the diet. In addition, some people may have had exposures to NDMA through the use of contaminated medications.

Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

An FDA quality-control nightmare reveals how impurities end up in America’s blood pressure pills.

Information about Nitrosamine Impurities in Medications

There are multiple reasons why nitrosamines can be present in drugs. FDA found the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. As foods and drugs are processed in the body, nitrosamines can also be formed. FDA continues to test and research possible sources for drugs found to contain nitrosamines.

Ranitidine’s N-nitrosodimethylamine Problem May be Tip of the Iceberg

The US Food and Drug Administration (FDA) has set an acceptable level of NDMA in each finished drug product (tablet or capsule) at no more than 96 ng (0.096 μg). Although this is less than the 190 ng of daily exposure to NDMA that the WHO finds acceptable, this is in addition to NDMA ingested from food, tap water, and other NDMA-containing drugs and dietary supplements. To date, the FDA has found excessive amounts of NDMA in several lots of angiotensin receptor blockers (ie, valsartan, losartan, and irbesartan), metformin extended release products, and ranitidine tablet and syrup products.

Understanding and Preventing (N-Nitrosodimethylamine) NDMA Contamination of Medications

N-nitrosodimethylamine (NDMA) is a hepatotoxic agent and carcinogen contaminant in commonly used medications such as valsartan, losartan, irbesartan, and ranitidine. NDMA can be produced during manufacture, introduced from contaminated ingredients procured elsewhere, or introduced from contaminated solvents and catalysts.

Zantac Has Low Levels of a Cancer-Causing Chemical, the F.D.A. Says

The chemical, NDMA, is the same one found in the blood pressure drug valsartan, which led to widespread recalls last year.

Resources

ToxFAQs

Your body makes low levels of NDMA from chemicals that are found naturally in foods. You may have more exposure if you eat certain foods (such as cured meats, fish, and cheese), drink water containing NDMA, or drink malted beverages (such as beer and whiskey).