A medicine having been considered as “Safe” since 1981 is recalled from the drug market. It’s not a surprise on recall of a drug from market which has an “assumed established safety profile”.
Ranitidine, popularly known to public as Zantac, is a very common OTC (over the counter) drug and prescription stomach acid blocker widely given to pediatrics, adults and the elderly patients. It is a histamine (H)-2 blocker, which decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Ranitidine global sales were approximately $412 million which is commonly used for intestinal and stomach ulcers, Gastroesophageal Reflux Disease (GERD), esophagitis, Zollinger-Ellison syndrome etc.,
In Sep 2019, an independent laboratory investigation in US has identified N-Nitrosodimethylamine (NDMA) in ranitidine medications and alerted FDA. The FDA found NDMA in ranitidine at low levels in their laboratory tests and alerted public about the potential risk and to consider for alternative OTC prescription medications by suspending Ranitidine.
NDMA is a well-known probable human carcinogen with the potential of causing cancer. However, USFDA and other key regulatory bodies of developed countries has not laid a complete recall on this drug due to less scientific evidence on the presence of this impurity in the drug. During this period (from Sep 2019 till March 2020), FDA started to investigate whether the low levels of NMDA found in the ranitidine medicines create a health risk.
Voluntary Recalls of Ranitidine product from Market
Few pharmaceutical companies have recalled their Ranitidine products from the market voluntarily after the FDA announcement of presence of NDMA impurity in Ranitidine.
Appco Pharma and Northwind Pharmaceuticals voluntarily recalled their Ranitidine products. On 25 Sep, GSK Pharmaceuticals Ltd suspended the distribution and supply of ranitidine products as a precautionary measure from all the markets including India. In October, Sanofi announced it Ranitidine recall from market. In the same month, Dr Reddy’s Laboratories had also initiated a voluntary recall of the medicine in the US.
USFDA announcement on 01 Apr 2020
In a news release, FDA requested to remove all Ranitidine products (Zantac) from the Market with the availability of strong scientific evidence of presence of greater amounts of human carcinogen, NMDA. FDA has determined that higher levels of NMDA is related to storage conditions of Ranitidine and identified that amounts of NMDA in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. Due to this drug recall request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. The FDA advised consumers to stop taking OTC ranitidine tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products as alternative treatments.
Alternative treatments to Ranitidine
FDA has not identified any NDMA impurities in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec), which are considered safe and alternative treatments for the similar therapeutic conditions.