In early April 2020, the FDA issued a recall of all prescription and over-the-counter ranitidine drugs. Ranitidine— better known by its brand name Zantac—was discovered to contain a carcinogen called N-Nitrosodimethylamine (NDMA) when stored at higher than room temperature. The FDA urged manufacturers to pull their products from the market and for consumers to dispose of any products in their possession.
An Organic Toxin
NDMA, a nitrosamine impurity, is a naturally occurring environmental toxin. Low levels can be found in water, meats, dairy products, and vegetables. It’s also labeled a “probable human carcinogen”, which means it is a potentially cancer-causing substance. NDMA has previously been detected in blood pressure and heart failure medications, which prompted past FDA recalls.
The FDA first alerted the public to the presence of NDMA in ranitidine medicines back in September 2019. In a press announcement, the FDA explained they were “evaluating whether the low levels of NDMA in ranitidine pose a risk to patients,” but didn’t indicate a pressing need to discontinue using these products. Following the announcement, CVS, Walmart, and Walgreens announced they would no longer carry Zantac products. Two weeks later, Zantac manufacturer, Sanofi, issued a voluntary recall of the drug.
Investigations continued along with additional voluntary recalls from various drugmakers also producing ranitidine medications. The FDA later discovered the levels of NDMA in ranitidine products will increase over time when stored at higher temperatures. This is exacerbated in higher storage temperatures and with older medication. These specific conditions yielded NDMA quantities that far exceeded the safe daily intake limits— and increased cancer risks.
The resulting levels of NDMA constituted a clear danger to users and prompted the official recall. “We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” said Janet Woodcock, M.D., director of the FDA’s Center of Drug Evaluation and Research, “However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”
Looking Towards Litigation
The FDA’s official request to manufacturers to halt production on ranitidine products signals a glaring hazard to consumers. Though preliminary testing of NDMA levels did result in a few voluntary recalls, there was not a clear directive to the public on whether to stop ongoing Zantac usage treatment. As a result, many users have likely been exposed to unhealthy levels of NDMA and could be at risk of developing cancer. Litigation has yet to be filed but numerous class action suits are already in the making against drugmakers.
As lawsuits are prepared, here are the expert witness specialties we’re likely to see called upon.
Pharmacology Expert: an expert in pharmacology will be essential for establishing an understanding of how ranitidine drugs react within the human body and recommended uses.
Chemistry Expert: a chemistry expert with pharmaceutical experience will offer important insights into the technical composition of ranitidine drugs and the science behind the development of NDMA. A chemistry expert can also provide detail on the toxic properties of NDMA and its risk to humans.
Safety Science Expert: a safety science expert can opine on regulatory practices from the perspective of a pharmaceutical company. This will be critical for understanding the safety measures employed during drug development and quality assurance practices for products already on the market.
Physician or Nursing Professional: a healthcare provider will be an important addition to the expert roster and can opine on the therapeutic uses of Zantac and other ranitidine drugs. Their expertise will help develop an understanding of why Zantac was prescribed and how a healthcare provider regards drug recalls.
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