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In 2019, a small laboratory in Connecticut found that ranitidine was associated with extremely high levels of N-Nitrosodimethylamine (NDMA) when heated.', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf004x01o8ap9wffav@published'}, {'data': {'text': 'NDMA is “<a href="https://www.atsdr.cdc.gov/ToxProfiles/tp141-c1.pdf">a volatile nitrosamine</a> that occurs widely in the environment due to its ready formation from commonly found precursors,” per the U.S. Centers for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry.', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf004y01o8on44lkla@published'}, {'data': {'text': 'By April 2020, <a href="https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market">the U.S. Food and Drug Administration announced</a> a request for drug manufacturers to “withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.”', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf004z01o8ozais3xx@published'}, {'data': {'text': 'It said the move was part of an ongoing\xa0<a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine">investigation</a>\xa0into NDMA contamination in the medications. Per the FDA, research showed that the impurity in some ranitidine products increased over time and when the products were stored in higher-than-room-temperature conditions.', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005001o8amxf4vuu@published'}, {'data': {'text': '“Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer,” said the administration. “However, sustained higher levels of exposure may increase the risk of cancer in humans.”', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005101o8kalbpti8@published'}, {'data': {'text': 'From the time the Connecticut lab found the NDMA connection to the FDA announcement, testing revealed that temperatures ranitidine products might be exposed to during distribution could cause NDMA levels to rise above an acceptable daily intake limit.', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005201o80mnm7v1w@published'}, {'data': {'text': 'GSK, a U.K.-based pharmaceutical company, first received approval for Zantac in 1983, said the Financial Times report. Sir Jonathan Symonds, chair of GSK and the company’s CEO, <a href="https://www.gsk.com/media/11113/q1-2024-results-transcript.pdf">Emma Walmsley</a> both said in statements this month that GSK believes studies show there is no causal link between ranitidine and cancer.', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005301o8q2n4a2ze@published'}, {'data': {'text': '“We remain resolute on our position on Zantac, the scientific evidence is clear, and we are hopeful there will be further clarity on the situation over the rest of 2024,” <a href="https://www.gsk.com/media/11118/chairs-statement.pdf">Symonds said last week</a>. According to the Financial Times, Pfizer issued a similar statement, explaining that it would “vigorously defend against Zantac lawsuits, which we believe are not supported by reliable science.”', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005401o864gdhnqy@published'}, {'data': {'text': 'Last month, <a href="https://www.cnn.com/2024/04/05/business/sanofi-to-settle-zantac-cancer-lawsuits/index.html">CNN reported</a> that French pharmaceutical company Sanofi “reached an agreement in principle to settle 4,000 U.S. lawsuits linking the discontinued heartburn drug Zantac to cancer,” in which it did not admit any liability.', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005501o8z17yd1te@published'}, {'data': {'text': 'Amidst the thousands of court cases in the U.S. related to Zantac,\xa0Judge Robin L. Rosenberg dismissed every Zantac lawsuit filed in the multidistrict litigation class in December 2022, <a href="https://www.millerandzois.com/products-liability/">said Miller & Zois Attorneys at Law</a>. That still left cases in state courts.', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005601o85c2xyskv@published'}, {'data': {'text': 'The Financial Times said the $200 million to 250 million settlement was disclosed in a court filing in Delaware last week and that it is aimed at reducing Pfizer’s potential liability.', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005701o88b4xezht@published'}, {'data': {'text': '“Reaching a settlement is a means to reassure investors and avoid what could be protracted and expensive litigation,” the outlet explained. “In 2022, companies linked to the drug lost a combined $40 billion in value in a matter of days when an analyst note published by Morgan Stanley estimated potential liabilities of up to $45 billion.”', '_version': 2, 'componentVariation': 'paragraph'}, 'original_ref': 'www.audacy.com/_components/paragraph/instances/clw9mivgf005801o8ccoo7blu@published'}, {'data': {'clipSrc': 'https://omny.fm/shows/noon-business-hour-on-wbbm-newsradio/retirees-jobs-nfl-schedule-release-day-ai-robocall', 'clipURL': 'https://omny.fm/shows/noon-business-hour-on-wbbm-newsradio/retirees-jobs-nfl-schedule-release-day-ai-robocall', 'embedSize': 'default', 'componentVariation': 'omny'}, 'original_ref': 'www.audacy.com/_components/omny/instances/clw9mivgf005901o8w26wbfm4@published'}, {'data': {'text': 'In Delaware, a state court judge is also soon expected to decide whether to admit scientific evidence linking Zantac to cancer. 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Pfizer to pay $250M to settle more than 10,000 lawsuits over cancer risks in Zantac

By Lauren BarryMay 16, 2024

Lauren Barry

Lauren Barry is a Chicago-based news content producer for Audacy’s central news team. She is the host/co-producer of The On Deadline Podcast, as…

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It looks like pharmaceutical company Pfizer will pay $250 million to settle more than 10,000 lawsuits filed over a heartburn drug it used to sell that has been linked to cancer risk, per a Financial Times report citing people familiar with the deal.

According to the outlet, New York-based Pfizer sold over-the-counter ranitidine drugs also known as Zantac from 1998 through 2006. In 2019, a small laboratory in Connecticut found that ranitidine was associated with extremely high levels of N-Nitrosodimethylamine (NDMA) when heated.

NDMA is “a volatile nitrosamine that occurs widely in the environment due to its ready formation from commonly found precursors,” per the U.S. Centers for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry.

By April 2020, the U.S. Food and Drug Administration announced a request for drug manufacturers to “withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.”

It said the move was part of an ongoing investigation into NDMA contamination in the medications. Per the FDA, research showed that the impurity in some ranitidine products increased over time and when the products were stored in higher-than-room-temperature conditions.

“Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer,” said the administration. “However, sustained higher levels of exposure may increase the risk of cancer in humans.”

From the time the Connecticut lab found the NDMA connection to the FDA announcement, testing revealed that temperatures ranitidine products might be exposed to during distribution could cause NDMA levels to rise above an acceptable daily intake limit.

GSK, a U.K.-based pharmaceutical company, first received approval for Zantac in 1983, said the Financial Times report. Sir Jonathan Symonds, chair of GSK and the company’s CEO, Emma Walmsley both said in statements this month that GSK believes studies show there is no causal link between ranitidine and cancer.

“We remain resolute on our position on Zantac, the scientific evidence is clear, and we are hopeful there will be further clarity on the situation over the rest of 2024,” Symonds said last week. According to the Financial Times, Pfizer issued a similar statement, explaining that it would “vigorously defend against Zantac lawsuits, which we believe are not supported by reliable science.”

Last month, CNN reported that French pharmaceutical company Sanofi “reached an agreement in principle to settle 4,000 U.S. lawsuits linking the discontinued heartburn drug Zantac to cancer,” in which it did not admit any liability.

Amidst the thousands of court cases in the U.S. related to Zantac, Judge Robin L. Rosenberg dismissed every Zantac lawsuit filed in the multidistrict litigation class in December 2022, said Miller & Zois Attorneys at Law. That still left cases in state courts.

The Financial Times said the $200 million to 250 million settlement was disclosed in a court filing in Delaware last week and that it is aimed at reducing Pfizer’s potential liability.

“Reaching a settlement is a means to reassure investors and avoid what could be protracted and expensive litigation,” the outlet explained. “In 2022, companies linked to the drug lost a combined $40 billion in value in a matter of days when an analyst note published by Morgan Stanley estimated potential liabilities of up to $45 billion.”

In Delaware, a state court judge is also soon expected to decide whether to admit scientific evidence linking Zantac to cancer. There is also a jury trial over Zantac related to GSK and Boehringer Ingelheim in Chicago, Ill.

“We are all waiting for what we think will be a big win in Delaware, where over 70,000 lawsuits are awaiting the court’s ruling and the Chicago Zantac trial that is ongoing,” said Miller & Zois earlier this month.

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