The U.S. Food and Drug Administration (FDA) has requested manufacturers to discontinue all versions of Zantac from the market, as it poses a risk to public health.
The FDA has urged the consumers to stop using any version of Zantac. Zantac is one of the top-selling products in the U.S. market for decades. It became the first medication to surpass 1 billion annual sales in 1988. But, it seems the manufacturers knew for years that Zantac causes cancer since the active pharmaceutical ingredient is inherently unstable and produces high levels of the NDMA, which is considered a carcinogen.
The public was not aware of the high levels of NDMA produced by Zantac until September 2019. An independent pharmacy, Valisure, conducted testing on Zantac, which claimed that each pill might result in a level of exposure higher than the limit set by the FDA regarding the intake of NDMA. The testing by Valisure indicated that 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA, contrary to 96 ng set by FDA.
Considering the facts about Zantac, the FDA has requested to recall all the Zantac products from the U.S. drug market.
In the ongoing investigation of Zantac to check the contamination level of N-Nitrosodimethylamine (NDMA) in this drug used for preventing ulcer. FDA has determined that Zantac, technically known as ranitidine has shown the result of an increase in impurity over time and when kept at a high temperature. Due to the request by the FDA for immediate market withdrawal of this drug used for heartburn treatment., Zantac will now not be available for prescriptions or over-the-counter usage.
The U.S. Food & Drug Administrations (FDA) posted a recall notice on its website following which American Health Packaging recalled ranitidine tablets, as the heartburn medication contained unacceptable levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
The recall notice includes 11 lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters, which American Health Packaging has notified its distributor to arrange the return of all recalled ranitidine products to Inmar Pharmaceuticals Services.
An online pharmacy Valisure first announced that it had detected high levels of NDMA in every drug sample it tested, following which Zantac and ranitidine recall began last year. The pharmacy petitioned the FDA, noting that the NDMA levels sometimes far exceeded the agency’s recommended guidelines. It also asserted that the ranitidine molecule resulted in the production of NDMA when the drug was subjected to conditions that mimic human digestion, which the agency is yet to determine.
After the decision to recall Zantac, the Director of FDA's Center for Drug Evaluation and Research stated that they did not come across unacceptable levels of NDMA in their samples, however, they are unsure since when the products have been stored. Therefore, they decided to make Zantac unavailable for consumers, until its quality is being assured.
Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome.
In 1983, Glaxo Holdings Ltd, a company that is a part of GlaxoSmithKline PLC, received approval from the FDA to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors.
Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.
NDMA is a human carcinogen that can lead to cancer. It must be noted that low levels of NDMA come in contact with humans while having their daily diet, as a low amount of human carcinogen is present in food and water which does not cause any harm and increase the risk of cancer. However, exposure to a higher level of NDMA can lead to severe health consequences, mainly cancer.
