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Questions and Answers: NDMA Impurities in Ranitidine (Commonly Known as Zantac)

November 1, 2019

What patients should know about NDMA impurities in ranitidine 

  • Not all ranitidine medicines marketed in the U.S. are being recalled.
  • FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng or 0.32 parts per million for ranitidine).
  • Some companies have recalled ranitidine based on tests showing levels of NDMA above the acceptable daily intake, while some have recalled without doing testing based only on the potential for NDMA in the drug.
  • Consumers may not know if the over-the-counter (OTC) ranitidine in their homes contains NDMA above the acceptable daily intake level because these recalls have been to the retail level, meaning they were only removed from store shelves. However, the NDMA levels we’ve found are similar to the levels you would expect to be exposed to if you ate common foods like grilled and smoked meats.
  • Consumers taking OTC ranitidine may consider using other OTC products approved for their condition. To date, FDA’s tests of samples of alternatives show no NDMA in: Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole).
  • Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine. 

Have all ranitidine medicines been recalled? How do I know if the ranitidine that I take or have at home is recalled?

Not all ranitidine medicines on the U.S. market have been recalled. Information about ranitidine recalls is available on FDA’s ranitidine web page.

Manufacturers’ information about recalled ranitidine are available on FDA’s website. These announcements provide information to help consumers identify the recalled medicine (e.g., National Drug Code numbers, lot numbers, dosage).

Consumers taking OTC ranitidine may consider using other OTC products approved for their condition. Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

Why are ranitidine products being recalled?

Several manufacturers have voluntarily recalled ranitidine. Information about all ranitidine recalls can be found on FDA’s recall webpage. Some companies have recalled because of levels of NDMA above the acceptable daily intake (96 ng per day or 0.32 parts per million for ranitidine), while some have recalled because of the potential of NDMA in the drug.

FDA is committed to helping ensure medicines Americans take are safe and effective. When we identify lapses in the quality of drugs that pose potential risks for patients, FDA makes every effort to understand the issues and provide our best recommendation to the public as quickly and accurately as possible. We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking their medicines without concern.

If all products are not recalled, why can’t I find ranitidine at my local pharmacy?

Some pharmacies decided to remove ranitidine from their shelves out of an abundance of caution. This does not necessarily mean the medicines were recalled.

Should I stop taking ranitidine?

FDA does not have scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines at this time, but our testing of ranitidine samples so far has shown levels of NDMA similar to the levels in common foods like grilled and smoked meats. There are multiple drugs that are approved for the same or similar uses as ranitidine. Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine may consider using other OTC products approved for their condition.

If you are taking one of the recalled medicines, you should follow the recall instructions provided by the company. This information is on FDA’s website.

What is the risk to me if I have taken ranitidine?

Through our testing, we have determined that the levels of NDMA in ranitidine and medicines are similar to the levels you would expect to find in common foods like grilled and smoked meats.

Are other H2 blockers and other drugs for stomach acid conditions impacted by the impurity? Are there safe alternatives to ranitidine?

FDA’s testing has not found NDMA in Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) at this time. In addition, assessment of their manufacturing processes indicates these medicines should not contain NDMA. FDA continues to test and assess other H2 blockers and proton pump inhibitors (PPIs) that could be used as alternatives to ranitidine.

Is the oral liquid/syrup affected?

FDA has tested some samples of liquid ranitidine, and they contain low levels of NDMA. Additionally, Lannett recalled ranitidine syrup due to levels of NDMA above the acceptable daily limit in the medicine.

How long has NDMA been present in ranitidine?

FDA does not have enough scientific evidence yet to determine how long NDMA has been present in ranitidine. The agency is continuing to investigate and will communicate more information as it is available.

Will ranitidine be back on the market?

Several manufacturers have voluntarily recalled ranitidine. Information about all ranitidine recalls can be found on FDA’s recall webpage. Some companies have recalled because of levels of NDMA above the acceptable daily intake (96 ng per day or 0.32 ppm), while some have recalled because of the potential of NDMA in the drug.

As manufacturers demonstrate levels of NDMA below the acceptable daily intake,  their ranitidine medicines may become available.

Is NDMA in drugs a new problem? Over the past year, why have there been so many reports of drugs containing NDMA?

FDA has ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure safe, effective, and high-quality drugs for the American public.

Certain drug manufacturing processes pose a risk for forming genotoxic impurities. For decades, FDA has provided guidance and recommendations for controlling impurities in drug substances and manufacturers have had an ongoing responsibility to test for impurities based on an understanding of their manufacturing process. In 2018, FDA issued a guidance to provide information to manufacturers regarding their responsibilities to assess the risk of impurities and implement appropriate controls for the manufacturing process. The agency identified some of the  root causes of the nitrosamine impurity problem in angiotensin II receptor blockers (ARBs).

We are working to determine the reason for the NDMA impurity in ranitidine.

Source: FDA

Posted: November 2019

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