Updates on Recalls for Medications Contaminated with the Carcinogen NDMA

By Jessica Pyhtila, PharmD, BCGP, BCPS

Over the past several months, the FDA has been involved in numerous product recalls linked to the nitrosamine impurity NDMA found in multiple product samples of two H2 antagonists. This spate of recalls comes on the heels of the recalls of angiotensin II receptor blockers, or ARBs, that began in 2018 and are still pending resolution in some cases.

NDMA, also known as N-nitrosodimethylamine and dimethylnitrosamine, is a known carcinogen in animals and is used in lab research to induce tumors. The chemical is also known to cause hepatic fibrosis and tumors in animals after prolonged exposure to low doses (1). For these reasons, NDMA is also widely suspected to be a human carcinogen. Although NDMA is a food contaminant found in cured meats, it is not known to bioaccumulate and, therefore, its presence has not garnered as much attention as its presence as a contaminant in certain medications (1).

H2 antagonists in which NDMA has been found include:

· Ranitidine: Also sold under the brand name Zantac, ranitidine is available as both an over-the-counter and prescription-strength H2 antagonist for acid reflux. The FDA issued an initial warning about the presence of NDMA in some ranitidine test samples in September 2019 (2). The FDA has requested that manufacturers not only conduct internal testing for NDMA, but also send drug samples for testing by the agency. Patients who elect to keep taking ranitidine are advised to limit their dietary intake of nitrite-containing foods like processed meats, because data suggest that NDMA may be formed in the body when ranitidine and nitrites are also present (2). As an alternative to ranitidine, providers may consider an alternate H2 antagonist like famotidine, also known as Pepcid, which has not been linked to NDMA contamination at this time.

It is important to note that not all manufacturers’ ranitidine products are impacted by the recalls. However, the manufacturers who have recalled some or all ranitidine at this time include:

· Nizatidine: Also known by its brand name Axid, this prescription H2 antagonist for acid reflux is also impacted by the FDA recall for NDMA contamination. No specific manufacturers have publicly issued nizatidine recalls (3). However, the FDA has identified nizatidine as one of the drugs contaminated by NDMA and effected by the recalls (2). Patients on nizatidine can consider converting to an H2 antagonist like famotidine, sold under the brand name Pepcid, which has not been linked to NDMA contamination.

References:

3) U.S. Food and Drug Administration. (December 18, 2019). “Statement on new testing results, including low levels of impurities in ranitidine drugs.” Retrieved from:

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