Three years after the Food & Drug Administration (FDA) pulled GSK Plc’s heartburn drug Zantac off the market due to suspected links to cancer, and just two weeks before the trial begins of a man who alleges he developed bladder cancer after taking the drug, Bloomberg Businessweek revealed in a new report the pharmaceutical company’s scientists have long knew about the drug’s risks.
Bloomberg’s lengthy report highlighted GSK scientists and independent researchers understood that ranitidine had a cancer-causing carcinogen known as N-Nitrosodimethylamine (NDMA). The drug was approved in 1983 as “Zantac” to treat acute duodenal ulcers and later as a remedy for heartburn.
By the late 1980s, Zantac was worth a whopping $2 billion, making it one of the most profitable drugs ever. It accounted for about half of Glaxo’s sales and 53% of the market for prescription ulcer medications.
Then use of Zantac soared further by the mid-1990s when the FDA approved it as an over-the-counter medication. GSK eventually controlled the heartburn remedy market for decades.
Bloomberg said GSK “backed flawed research designed to minimize concerns and chose not to routinely transport and store the medication in ways that could have eased the problem.”
“Glaxo sold a drug that might harm people, tried to discount evidence of that and never gave anyone the slightest warning,” Bloomberg continued, adding its team of journalists reviewed “thousands of pages,” including court filings and studies.
Four decades of dominating the heartburn market and building a pharmaceutical empire around it — abruptly stopped several years ago for GSK. In September 2019, the FDA received a report that made claims about ranitidine containing high levels NDMA. Shortly after that, in April 2020, the FDA pulled all ranitidine products from the market over the cancer-causing risks surrounding NDMA.
Trust the science https://t.co/wH5fsKPqkv
— zerohedge (@zerohedge) February 20, 2023
The FDA stated concerns about the storage methods of the drug, indicating:
“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.”
According to Bloomberg, the FDA found 357ng of NDMA in Zantac, a level four times higher than what’s acceptable in any FDA-approved drug. And what’s frightening is that NDMA levels soared to 931ng in the same product five months later.
And just how many people are suing manufacturers of Zantac or generic versions?
More than 70,000 people who took Zantac or generic versions of it are suing the company in US state courts for selling a potentially contaminated and dangerous drug. –Bloomberg
The first trial of a man who alleges he developed bladder cancer after taking Zantac will begin Feb. 27 before Alameda County Superior Court Judge Evelio Grillo. This will be the first test to see how cancer-causing Zantac claims holds up in state courts.