Trial News

On April 1, the FDA issued a letter to all manufacturers of ranitidine—known by the brand name Zantac—to immediately pull the antacid from the market because of evidence of contamination with a probable human carcinogen. The FDA also advised consumers not to take any raniditine products—brand-name and generic versions—they have at home and to dispose of the medication according to the procedures listed on the package labeling.

Last year, independent testing revealed that ranitidine products were contaminated with N-Nitrosodimethylamine (NDMA)—a probable human carcinogen—as a byproduct of the drug’s active ingredient. Litigation against the drugmakers for different types of cancer allegedly caused by this contamination is ongoing.

While the FDA does not have mandatory recall authority, it has requested that manufacturers withdraw from the market all prescription and over-the-counter versions of the drug. It has been investigating ranitidine contamination since an independent laboratory alerted the agency about the problem last year. While NDMA may be safe at low levels, the agency said, testing revealed that NDMA levels increase over time and can then exceed recommended exposure limits—and the older the product is, the higher the NDMA levels.

The risk is especially high in products stored at higher-than-recommended temperatures—such as in a hot car—but NDMA levels can still increase even in products stored under recommended conditions. Even though not all samples the FDA tested indicated dangerous levels of NDMA, the agency is recommending a complete recall of all ranitidine products since it is impossible to know how long and under what conditions the medication has been stored.

More than 140 products liability lawsuits and class actions have been consolidated in multidistrict litigation in the Southern District of Florida (In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924), and the plaintiffs allege that the manufacturers knew or should have known about the contamination and that it caused injuries including stomach, kidney, and bladder cancers. In an April 3 order, the judge presiding over the MDL scheduled a May 12 initial conference via videoconference to keep the litigation moving forward during the pandemic.

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