Although the levels of NDMA that was found through FDA testing are much lower than the levels that a few third-party investigators claimed, the report indicated that these levels exceed what the FDA considers acceptable for these medicines.
The FDA has released new information regarding impurities in ranitidine (Zantac) and Nizatidine (antacid) products, stating that the levels of N-Nitrosodimethylamine (NDMA) they contain are “similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
The report is part of an ongoing investigation of NDMA levels in ranitidine and nizatidine products.1
The agency has tested numerous ranitidine products on the market over the past few months and conducted gastric fluid model that simulates, in combination with the LC-MS testing method, what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet. The results of these tests indicate that NDMA is not formed through this process, according to an FDA statement released on Friday.
Although the levels of NDMA found through FDA testing are much lower than the levels that a few third-party investigators have claimed, the report indicated that these levels exceed what the FDA considers acceptable for these medicines. Consuming up to 0.096 micrograms or 0.32 parts per million (ppm) of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. The FDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine.1
“We know impurities in medicines are of great concern to patients and consumers who rely on safe and effective medicines approved by the FDA, and we are working with manufacturers and global regulators to provide clear and actionable information. These investigations take time and do not provide instantaneous answers,” Jane Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA.2
The FDA is recommending recalls to manufacturers with products containing NDMA levels above the acceptable daily intake limit. The agency is also asking manufacturers to continue conducting their own laboratory testing to examine these levels of NDMA in ranitidine and nizatidine products as well as to send samples to the FDA to be tested by their scientists.
“In the meantime, our recommendations for consumers and patients have not changed. Consumers taking OTC ranitidine or nizatidine can consider using other OTC products approved for their condition,” continued Woodcock in her prepared statement.2
So far, the FDA and industry testing of medicines in the histamine-2 (H2) blocker and proton pump inhibitor (PPI) classes has identified NDMA only in ranitidine and nizatidine. The FDA’s tests of samples of alternatives, such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) and omeprazole (Prilosec); show no NDMA impurities in the medicines.1
“The FDA is committed to sharing all findings when we have adequate understanding of the situation and of what actions should be taken. We will continue to work with drug manufacturers to ensure safe, effective, and high-quality drugs for the American public,” Woodcock concluded.2