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March 3rd, 2023Zantac and its active ingredient, ranitidine, reigned over the heartburn medication market for over forty years. That is until the massive 2020 recall pulled Zantac and all other ranitidine products from markets. Testing discovered alarmingly high levels of a known human carcinogen, NDMA, in ranitidine-based drugs. However, a new report by Bloomberg reveals that a Zantac manufacturer may have known about the dangers of the heartburn drug for decades.
FDA testing revealed levels of NDMA in Zantac and other ranitidine-containing drugs in 2019. However, the FDA considered the levels too low to initiate a recall. That changed in 2020 when the agency discovered that NDMA could increase over time and at higher temperatures. The increase in NDMA could expose individuals to unsafe levels of the carcinogen.
Several agencies recognize NDMA as a probable human carcinogen, such as the World Health Organization and the EPA. NDMA was first linked to cancer in 1956, and more research has supported this notion since then. Tens of thousands have filed lawsuits against Zantac manufacturers, including GSK (previously known as Glaxo), Pfizer, and Sanofi. Individuals claim they developed several cancers after taking ranitidine medication, including stomach, bladder, prostate, and pancreatic cancer.
Bloomberg Businessweek reviewed hundreds of documents obtained through the Freedom of Information Act that span over four decades of Zantac findings. Court filings, studies, FDA transcripts, and drug applications reveal GSK, previously called Glaxo, knew that Zantac was potentially carcinogenic.
In 1980, Zantac investors learned that ranitidine could form a potentially carcinogenic compound in the stomach. Yet, Glaxo’s head of public relations advised against overreacting and telling the public. Only a year later, Glaxo scientists found long-term ranitidine use could cause more carcinogens to form. The scientists concluded people should not take Zantac for an extended time, but Glaxo never specified this on Zantac’s label.
There is also evidence that Glaxo concealed or dismissed studies that found Zantac could react to nitrite in the stomach to form NDMA. Smith, Kline & French, the maker of another antacid, sent Glaxo a study in 1982 confirming the creation of NDMA when ranitidine reacts with nitrites. Skeptical, Glaxo conducted its own tests only to find the same results. Glaxo hid the study from medical advisors and the U.S. associate director of clinical research. In fact, Glaxo specifically left out this study when the company presented to a panel of FDA officials to approve Zantac in the U.S.
Documents also exposed that Glaxo knowingly ignored scientists’ instructions to store and ship Zantac. For example, the head of pharmaceutical development insisted that injectable Zantac had to remain chilled during transportation and storage. Not doing so would be “a very dangerous thing” since it is sensitive to temperature. Glaxo executives replied refrigeration would not be suitable for marketing.
Following its FDA approval, Glaxo heavily marketed Zantac as the safest heartburn drug and worked hard to discredit alternative medicines. Although Zantac had grown into a billion-dollar drug, the problems did not go away. When working on an over-the-counter lower dosage form of Zantac, researchers found the pills would turn from white to yellow or brown. Discoloration signals that the pills are degrading, which can cause harmful impurities. Glaxo concealed the discoloration with a bright pink coating. In 2010 and 2015, more problems surfaced with Zantac injections and tablets turning yellow. NDMA used in lab tests is yellow, but Glaxo scientists did not test for it.
A federal judge dismissed the Zantac multidistrict litigation (MDL) in December 2022. The judge ruled there was insufficient scientific evidence to link ranitidine to cancer. But, this decision, which Zantac attorneys plan to appeal, hasn’t stopped thousands of state Zantac claims. Although manufacturers repeatedly state the heartburn drug does not cause cancer, over forty years of scientific evidence suggests otherwise.
If you were diagnosed with cancer after taking Zantac, The Lake Law Firm can help you. One of our Zantac attorneys is on standby to speak with you if you suspect the heartburn drug caused your injuries. You may qualify for financial compensation that can help you cover medical costs and assist you in your recovery.
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 555-3529 or submit an inquiry on this page.
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