Days after a probable carcinogen was detected at low levels in heartburn medications, drug manufacturers have voluntarily recalled the over-the-counter available ranitidine tablets. The drugs have been recalled over the possible presence of cancer-causing impurity called N-nitrosodimethylamine or NDMA above the allowed limits. They were being sold at Walmart, Walgreens, and Rite Aid. While Walmart and Ride Aid were selling tablets as ranitidine, Walgreens was reportedly selling it under the store brand name Wal Zan. One of the manufactures of ranitidine has recalled generic tablets in 75 and 150-milligram doses available at the above-mentioned places. The Food and Drug Administration of the US has alerted patients as well as health care professionals regarding the development.
Earlier on September 13, the FDA had announced that it had learned that some ranitidine medicines, including those under the brand name Zantac, have the presence of NDMA at low levels. The FDA is now testing the medicines from various manufacturers for the presence of N nitrosodimethylamine. The possible effect of NDMA on patients at found levels is being assessed by the FDA, which is also trying to find what measures these manufacturers can take to eliminate or reduce NDMA in medicines. Countries like Canada have asked manufacturers to stop distributing ranitidine drugs there till the time it assesses NDMA.
The FDA has advised the patients taking ranitidine who wish to stop using it to speak to their doctor or health care professional about other options. NDMA is among the nitrosamine impurities which are considered carcinogenic over long term exposure at certain levels. Earlier, British drugmaker GlaxoSmithKline recalled ranitidine products in India and Hong Kong and Novartis-owned Sandoz recalled 500 count, 50 count, 30 count bottles of prescription ranitidine capsules. NDMA and few other cancer-causing substances have also led to widespread recalls of heart and blood pressure medications since last year. Manufacturing flaws were blamed for that. But in this case, particular case experts believe that it is likely that enzymes in an individual’s body react with the ranitidine molecule and actually create NDMA.