The move from the Food and Drug Administration Wednesday applies to all prescription and over-the-counter versions of ranitidine, best known by the brand name Zantac. In a statement, the FDA said they became aware of NDMA contamination in ranitidine products found by independent laboratory testing.
But officials reversed that decision, saying they've now determined that levels of the chemical increase over time, especially if tablets and capsules are stored at higher temperatures.
Many makers of ranitidine drugs already removed their products from the market, including Zantac-manufacturer Sanofi. Among the suggested OTC replacements are Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole).More news: U of M's Ruiz could be pick for Lions in NFL Draft
The FDA sent letters to all companies that manufacture Zantac asking they withdraw the products from the market. Based on these findings, the FDA concluded that the levels of NDMA may increase to levels above the acceptable daily intake limit.
Low levels, according to the FDA, are "commonly ingested" in food and water.
New testing and evaluation conformed NDMA levels increase even under normal storage conditions and increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.More news: Yuvraj Singh Opens Up on The Side Effect of IPL on Youngsters
Due to the coronavirus pandemic, the FDA said don't return your medicines to a "drug take-back location", but rather follow disposal instructions in the medication guide or insert - or follow the FDA's recommended safe disposal steps on its website. And, the longer the product is stored the level "greater the level of NDMA". A press release from the FDA noted that there are multiple approved drugs for the same or similar uses, without the same risks from NDMA.
The FDA also said consumers taking over-the-counter ranitidine should stop taking the drug and not buy more, and those taking prescription ranitidine should ask their doctor about other options before discontinuing treatment.More news: 28 students positive for coronavirus after spring break trip