Pfizer Proposes $200-250 Million Settlement for Heartburn Med Drug Lawsuits: Source

The giant pharmaceutical company Pfizer is ready to pay between $200-250 million as a result of over 10,000 U.S. lawsuits involving supposed cancer risks associated with the drug Zantac, which it sold between 1998 and 2006, sources told the Financial Times.

Zantac was approved in 1983, becoming the world’s largest-selling medicine by 1988. But in 2019, after a Connecticut lab heated ranitidine, the active ingredient in Zantac, and found “extremely high levels” of NDMA, a probable human carcinogen, the Food and Drug Administration asked for Zantac and its generic equivalents to be pulled off the market in April 2020.

“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,” the FDA wrote. “As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.”

“Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water,” the FDA continued. “These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. … New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and 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. The 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. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”

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“The settlement — which was disclosed in a court filing in Delaware last week — is aimed at significantly reducing Pfizer’s potential liability,” Financial Times noted, adding that Pfizer stated, “The company is confident that its Zantac products, which were reviewed and approved by the [US Food and Drug Administration], did not cause cancer when used as directed.”

“GSK, which first received approval for Zantac in 1983 and is most exposed to the litigation, has already settled a handful of cases in courts in California. It disputes that the drug caused cancer,” Financial Times reported.

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