FDA Requests Removal of All Ranitidine from Market

Officials with the FDA have requested that manufacturers of all ranitidine (Zantac) drugs, both prescription and over-the-counter, remove their products from the market, according to a press release. As a result of this market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the United States, according to the agency.

As a result of its ongoing investigation into traces of N-nitrosodimethylamine (NDMA) found in some ranitidine medicines, the FDA is urging immediate market withdrawal due to its findings. According to the FDA, they have determined that the impurity in some ranitidine products increases over time, even under normal storage conditions, and when stored at higher than room temperatures, which may result in consumer exposure to unacceptable levels of this impurity.

“These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily limit,” the FDA said in its release.

NDMA, a probable human carcinogen, was previously identified in some ranitidine products back in summer 2019, prompting an ongoing investigation. The FDA conducted laboratory testing and found low levels of the carcinogen in ranitidine, but at the time did not have enough evidence to make a determination on whether consumers should stop taking the medicines.

“Ranitidine products will stay off the market unless a manufacturer can show that their product is stable while stored and does not generate excess NDMA,” Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA, wrote in a tweet.

In September 2019, the FDA issued a warning to the public of the potential risks, and offered alternative OTC and prescription treatments.

Following today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. Additionally, the FDA is advising consumers to stop taking OTC ranitidine and dispose of them properly. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine.

Due to the COVID-19 pandemic, the agency also urges patients and consumers to refrain from taking their medicines to a drug take-back location, and instead follow the specific disposal instructions in the medication guide or package insert.

References:

1. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market. Accessed April 1, 2020.