FDA Requests Withdrawal of Rx and OTC Ranitidine from US Market

The US Food and Drug Administration reported earlier this month (April 1, 2020) that it has requested manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs, used as anti-acids, from the market.

This is the latest step in an ongoing investigation of an impurity, N-Nitrosodimethylamine (NDMA), in ranitidine medications. The agency has determined that the impurity in some ranitidine products increases over time, and when stored at higher than room temperatures, it may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate (as of April 1, 20200 market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the US.

NDMA is a probable human carcinogen. In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water, according to the FDA. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. The FDA said it conducted thorough laboratory tests and found NDMA in ranitidine at low levels. At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

The FDA said that bew FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

The FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any 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.

Source: US Food and Drug Administration

Leave a Reply

Your email address will not be published. Required fields are marked *