The passage from the Food and Drug Administration on Wednesday applies to all prescription and over-the-counter versions of ranitidine, better known by the brand name Zantac. Drugs are widely used to treat stomach acid and ulcers.
Patients should stop taking one of the medications they currently have and discard it, the FDA said.
Last year, the agency said that patients could continue taking the drugs and were not at risk from health concerns due to low levels of a “likely” carcinogenic contaminant found in several brands.
But officials reversed the decision, saying they have now determined that the levels of chemicals increase over time, particularly if the tablets and capsules are stored at higher temperatures. This poses an unacceptable risk to patients, they said.
“Because we do not know how or for how long the product could be stored, we decided that it should not be available to consumers and patients,” said Dr. Janet Woodcock in a statement.
Woodcock said there are many alternative drugs to treat heartburn, including Prilosec, Nexium and Tagament.
Many manufacturers of ranitidine-based drugs have already withdrawn their products from the market, including the manufacturer of Zantac, Sanofi. In addition, several pharmacy chains removed the drugs from their shelves last year.
Dozens of recalls have been linked to the same likely carcinogen since last year. The FDA is still studying the matter and has sanctioned at least one manufacturing plant in India that manufactures ingredients used in drugs.
The FDA has suspended almost all US and foreign inspections due to travel restrictions caused by the coronavirus epidemic.