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FDA Requests Removal of Ranitidine (Zantac) Products From Market for Potential Carcinogen

On April 1st, the Food and Drug Administration (FDA) announced its request for all prescription and over-the-counter ranitidine drugs to be removed from the market immediately. This decision was made based on an ongoing investigation of the potential risk of N-nitrosodimethylamine, or NDMA, to public health. Here, the product liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo P.C. discuss the FDA’s ongoing investigation of NDMA, and the potential risk this contaminant may pose to consumers.

NDMA Levels in Ranitidine Pose Potential Carcinogenic Risk 

Ranitidine, commonly known by the brand name Zantac, is a medication that is commonly used to treat stomach ulcers, gastroesophageal reflux disease (GERD) and other acid-related damage to the esophagus. However, NDMA has been detected during batch testing of ranitidine. NDMA has been designated as a probable human carcinogen by the U.S. Environmental Protection Agency, Food and Drug Administration and the International Agency for Research on Cancer.  There has been an ongoing investigation on the impacts of NDMA by the FDA since September 2019, and further research has discovered that the levels of NDMA present in medications such as Zantac exceed the daily acceptable intake limit, posing potential risks for consumers. 

Prior to the FDA’s request that Zantac and generic ranitidine be removed from the market, drugmaker Sanofi issued a voluntary recall of their heartburn medication. During testing, it was discovered that levels of NDMA increased under normal storage conditions, during manufacturing and in general consumer use of the medication. It was also discovered that the longer the length of time since a batch of medicine was manufactured, the higher the levels of NDMA it contained.  NDMA is a chemical that was once used to make rocket fuel and its only practical purpose in the U.S. is to induce tumors in lab animals to help in studying cancers.  

FDA Requests Home Disposal of Medications During COVID-19 Pandemic

With the announcement of the removal of all ranitidine drugs from the market, the FDA has requested that consumers who currently have access to Zantac or similar medication containing NDMA dispose of these medications and not purchase more until further notice. In light of the current COVID-19 pandemic, the FDA recommends that consumers not take these medications to a drug take-back location, but rather, follow instructions on the medication’s information packet to properly dispose of these medications at home. It is also recommended that you consult your current healthcare provider to discuss alternative options for over-the-counter medication.  Though we agree with the recommendation not to use the drug, if you think you may have a claim for injuries sustained due to the use of Zantac, please do not discard the drug.  If you think you have a claim, it is important that you preserve the drug because it could be evidence in your case.

Speak With a Product Liability Attorney at Sullivan Papain Block McGrath Coffinas & Cannavo P.C.

The dedicated product liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. advocate for victims of negligent practices by companies who have a social responsibility to uphold and prioritize public health. If you or a loved one have taken Zantac or generic ranitidine, contact the team of New York pharmaceutical liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. today.

 

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