US FDA withdraws all ranitidine medicines

US FDA withdraws all ranitidine medicines

2 April 2020 - Deborah Wilkes

The US Food and Drug Administration (FDA) has asked manufacturers to withdraw all prescription and OTC medicines containing ranitidine from the market immediately.

Consumers taking OTC medicines containing ranitidine have been told to “stop taking any tablets or liquid they currently have, dispose of them properly and not buy more”.

The FDA said new studies showed that levels of N-nitrosodimethylamine (NDMA) – a probable human carcinogen – were a “risk to public health”.

The regulatory agency pointed out there were “multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA”. The FDA said that its testing to date had “not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec)”.

The withdrawal comes six months after the FDA announced a safety review following tests that showed some ranitidine medicines contained NDMA (click here to read the News story).

At the time, the FDA stressed that the levels of NDMA found in ranitidine from preliminary tests "barely exceed amounts you might expect to find in common foods".

Sanofi's voluntary recall

Soon afterwards, in October 2019, Sanofi Consumer Healthcare announced a “precautionary” voluntary recall of Zantac (ranitidine) in the US and Canada.

The company recorded negative sales of Zantac in the fourth quarter of 2019, reflecting the recall as well as additional provisions for product returns (click here to read the News story). In the same period a year earlier, sales of Zantac were EUR34 million (USD37 million).

Other manufacturers and retailers also voluntarily recalled ranitidine medicines.

The FDA now says the impurity in some ranitidine products “increases over time and when stored at higher than room temperatures”. This “may result in consumer exposure to unacceptable levels of this impurity”, it added.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” commented Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). “However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”

Commenting on its initial response, the FDA said it had 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,” added the regulatory agency, noting that it had continued its investigation, and warned the public of the potential risks and to consider alternative OTC and prescription treatments.

The FDA said new testing and evaluation prompted by information from third-party laboratories had confirmed that “NDMA levels increase in ranitidine even under normal storage conditions”.

“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,” said the FDA.

Furthermore, continued the FDA, 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”.

According to the FDA, these conditions “may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit”.

The US Consumer Healthcare Products Association (CHPA) said it respected the "FDA’s decision to act out of an abundance of caution". "We look forward to learning more about the agency’s work and testing results to fully understand the product storage conditions that could lead to potential formation of NDMA," added the industry association.

Safety reviews in other countries and regions, including the European Union, are ongoing.

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