Drug Industry Looking For Ways To Prevent Future NDMA Contamination: Report

Over the past two years, a number of pharmaceutical products have been found to contain the cancer-causing chemical N-nitrosodimethylamine (NDMA), leading to massive recalls for Zantac, valsartan, metformin and other popular medications. As a result manufacturers and health experts have expressed concerns that the cancer-causing chemical byproduct may be a widespread contaminant throughout the U.S. drug supply.

NDMA is considered a carcinogen, and is mostly known as a byproduct of making rocket fuel. Howver, today it is primarily only used in laboratory experiments to induce cancer in animal test subjects.

Detection of the NDMA problems in a widely distributed heartburn and blood pressure drugs have resulted in Zantac recalls, generic valsartan recalls and other regulatory actions after it was confirmed that levels of NDMA present in the pills exceed the threshold determined to be safe by federal regulators.

On April 20, a report by Chemical & Engineering News warned that pharmaceutical industry experts are concerned about how prevalent NDMA may be among their drug products, since many have never actually tested for the cancer-causing chemical despite their products being on shelves for years, and despite indications that some manufacturers knew NDMA was likely present in their drugs for decades.

The companies now face pressure from the FDA to explain how future contamination can be prevented, both from NDMA and other harmful contaminants as well.

In some cases, such as with valsartan and other sartan-based drugs, which are prescribed as hypertension treatments, NDMA was introduced to the medication as part of the manufacturing process. However in other drugs, like Zantac’s active ingredient ranitidine, it appears to be a byproduct of chemical processes created by the drug itself.

According to the report, many means of detecting NDMA did not exist until recently, which has made finding NDMA in long-used drugs much easier. However, according to allegations raised in a number of recently lawsuits, some manufacturers knew or should have known about the presence of NDMA for decades.

In hundreds of recently filed Zantac lawsuits brought by former users of the heartburn drug diagnosed with cancer, plaintiffs allege that the pharmaceutical industry had information for decades that suggested NDMA may be created as a byproduct of ranitidine’s exposure to heat, either in the body or during storage. This means that users were likely exposed to the carcinogen since the blockbuster drug was introduced in the 1980s.

The European Medicines Agency and Health Canada have put out guidelines requiring drug manufacturers to conduct NDMA risk evaluations. The EMA guidelines were issued in September 2019 and the Health Canada guidelines were released in December 2019.

To date, no similar guidelines have been issued by the FDA.