04:01 PM EDT, 10/09/2024 (MT Newswires) -- GSK (GSK) on Wednesday announced a settlement resolving a bundle of 80,000 product liability cases in the US that alleged its over-the-counter heartburn medication, Zantac, increased the risk of cancer.
GSK agreed to pay up to $2.2 billion as part of the agreement with 10 plaintiff firms representing 93% of the Zantac state court liability cases. GSK said these firms are unanimously recommending their clients to accept the terms of the deal. The company's New York Stock Exchange-listed shares rose more than 6% just ahead of market close on Wednesday.
The settlement is expected to be fully implemented by the end of the first half of 2025, according to a statement.
The British drugmaker also agreed in principle to pay $70 million to resolve a complaint filed by Valisure, which in 2019 petitioned the Food and Drug Administration to recall all products that contained ranitidine due to its potential link with a contaminant known as N-Nitrosodimethylamine, or NDMA. Ranitidine is Zantac's active ingredient. Valisure did not immediately respond to MT Newswires' emailed request for comment.
NDMA is a probable human carcinogen, a substance that could cause cancer, the FDA said in April 2020, when the agency asked manufacturers to immediately remove all ranitidine products from the market. "The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity," the FDA said at the time.
GSK has not admitted to any liability. "While the scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer, GSK strongly believes that these settlements are in the best long-term interests of the company and its shareholders," according to a statement.
The company expects to recognize a 1.8 billion British pound incremental charge ($2.35 billion) in the third quarter related to the settlements, as well as the remaining 7% of pending product liability cases.
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