The U.S. Food & Drug Administration (FDA) is requesting manufacturers to immediately pull drugs containing ranitidine from the market.
The move, announced in an FDA press release on April 1, 2020, is the latest step in an ongoing investigation that has linked public health risks to a contaminant known as NDMA in ranitidine drugs.
Ranitidine, commonly referred to by the brand name Zantac, is used to treat heartburn.
Here are a few facts about the FDA’s request and ranitidine investigation:
- In its announcement, the FDA noted an ongoing investigation determined levels of a contaminant known as N-Nitrosodimethylamine (NDMA) in heartburn medications containing ranitidine can increase over time, and when stored at higher-than-normal temperatures. This can result in unacceptable levels of consumer exposure to the contaminant.
- The contaminant at issue, NDMA, is a probable human carcinogen – meaning it could cause cancer, and the FDA has been investigating levels of it in ranitidine since mid-2019.
- Though people commonly ingest NDMA in low levels naturally through their diet, those levels are not expected to increase cancer risks. However, sustained exposure to higher levels may.
- In September 2019, the FDA issued a warning about potential risks and advised consumers to consider alternative OTC and prescription heartburn treatments. CVS, Walgreens, and Walmart also pulled Zantac and other OTC ranitidine drugs from shelves, and in October, drugmaker Sanofi voluntarily recalled Zantac OTC sold in the U.S. and Canada over “inconsistencies in preliminary test results.”
The request for immediate removal of ranitidine drugs means ranitidine products like Zantac will not be available for new or existing prescriptions, or as over-the-counter drugs, in the U.S. Consumers are also advised to stop taking Zantac and any ranitidine tablet or liquid medications they currently have, dispose of them, and not purchase more.
As the FDA Center for Drug Evaluation and Research Director Janet Woodcock said in the announcement:
"We didn't observe unacceptable levels of NDMA in many of the samples that we tested. 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."
In light of the COVID-19 pandemic, the FDA advises consumers to not return medicines to drug-take-back locations, and instead to follow disposal instructions on medications, or in accordance to the FDA’s recommended safe disposal steps. The FDA has of not found NDMA in other products, including Pepcid (famotidine), Nexium (esomeprazole), or Prilosec (omeprazole).
BCH Is Actively Reviewing Potential Ranitidine / Zantac Lawsuits
Bailey Cowan Heckaman PLLC has been closely following the FDA’s ongoing investigation into ranitidine and Zantac cancer risks, and studies dating back to 2004 which have found risks of bladder cancer due to high levels of NDMA. Despite years of concern, Zantac maker Sanofi failed to bring this information to the public’s attention.
While investigations continue, BCH is actively reviewing cases from individuals and families who may have potential claims, including those involving people who have been diagnosed with bladder, kidney, stomach, or similar cancers, and who have had prescriptions for or long-term use of Zantac or ranitidine products.
BCH is a nationally recognized Civil Trial Law Firm with a highly regarded practice focusing on class multi-district litigation (MDL) and major pharmaceutical injury cases. If you have questions about Zantac lawsuits and your rights and legal options, call or contact us online to request a free consultation. Based in Houston, BCH serves victims and families nationwide.