April 1, 2020
The U.S. FDA has asked all manufacturers of ranitidine-containing products to remove the drugs from the U.S. market. The move comes after the agency determined N-nitrosodimethylamine (NDMA) levels in ranitidine may increase over time. NDMA is considered a likely human carcinogen (cancer-causing substance).
In the summer of 2019, manufacturers recalled multiple ranitidine products following discovery of NDMA contamination. NDMA impurity is believed to result from the manufacturing process. While the level of impurity was initially believed to be low in most recalled products, further study has shown that NDMA content can increase over time. The increase becomes more rapid when ranitidine is exposed to higher temperatures – for instance, during distribution or when being transported or handled by a consumer. This means that NDMA levels can increase beyond what initial laboratory tests indicate for a given lot of ranitidine.
Ranitidine is available both over the counter (OTC) and as a prescription medication. It is used to treat ailments such as heartburn, gastroesophageal reflux disease, and gastrointestinal ulcers. The FDA recommends that consumers stop using and purchasing OTC ranitidine, such as Sanofi’s Zantac®, and properly dispose of any in their possession. If a patient uses a prescription ranitidine product, the FDA recommends they speak to a healthcare professional about other available treatment options before stopping the medication. Alternatives available over the counter or by prescription include famotidine (Pepcid® – Merck), cimetidine (Tagamet® – GlaxoSmithKline), esomeprazole (Nexium® – AstraZeneca), lansoprazole (Prevacid® – Takeda), and omeprazole (Prilosec® – Procter & Gamble).
The full withdrawal notice can be viewed on the FDA’s website.
Benecard Central Fill has halted distribution of all ranitidine products and communicated next steps to affected members.