Is it still safe to take Zantac? What about the drug recalls?
What is Zantac?
Zantac (generic name Ranitidine) is a type of antacid commonly used in the treatment of heartburn and acid reflux. It belongs to a family of medications called H2 (histamine-2) blockers, which function by reducing the production of stomach acid. Ranitidine is available in both prescription and over-the-counter (OTC) versions, and there are many different manufacturers who make both brand name and generic Ranitidine.
What happened with the drug recalls?
On September 13, 2019, the FDA announced that some versions of Ranitidine contained low levels of a substance called NDMA, which is a contaminant that has been linked to an increased risk of cancer. Shortly following the announcement, multiple drug companies recalled both brand name and generic Ranitidine due to concerns over higher than acceptable levels of NDMA. Multiple large pharmacy chains, including CVS and Walgreens, soon pulled all versions of the drug from their shelves. According to most recent updates from the FDA, 14 manufacturers to date have announced voluntary recalls of Zantac and Ranitidine.
What is NDMA?
Nitrosodimethylamine (NDMA) in an environmental contaminant found in water and certain foods, including dairy, produce, and grilled or cured meats. The FDA has established levels of daily exposure to NDMA which are thought to be safe. Above these levels, chronic daily exposure over many years may pose an increased risk of cancer based on studies in animals, although studies in humans are limited. If a drug is found to have higher than the recommended levels of NDMA, the FDA recommends recall by the manufacturer, which is what occurred in the case of Ranitidine.
What should I do if I take Zantac or Ranitidine?
It is important to know that NDMA dose pose any immediate threat if you have been taking Ranitidine. Thus far, the FDA has not recommended that patients stop taking Ranitidine if it was prescribed by their doctor. Patients are encouraged to discuss their condition and treatment with their doctor, however, since there may be an alternative to Ranitidine which is safe and equally effective. Patients using OTC Zantac or Ranitidine may consider another OTC alternative, as there is no evidence that other H2 blockers (e.g. Pepcid, Tagamet) or other types of heartburn drugs (e.g. proton pump inhibitors) have been contaminated with NDMA. We recommend that all our patients taking Zantac or Ranitidine contact their doctor to discuss the best treatment plan going forward.