A US court has dismissed thousands of lawsuits against pharmaceutical firms GSK, Pfizer, Sanofi, and Boehringer Ingelheim claiming that the heartburn medication Zantac (ranitidine) caused cancer.
The decision by US District Judge Robin Rosenberg in West Palm Beach, Florida found that the claims were not supported by sound science.
In the ruling, the judge dismissed about 50,000 claims in federal court. However, the ruling does not have a bearing on thousands of similar cases pending in state courts in the US, reported Reuters.
According to a Sanofi spokesperson, the decision considerably brings down the scope of the litigation possibly by more than 50%.
Zantac, which received its first approval in 1983, was sold as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion. It was initially marketed by a predecessor of GSK and later sold successfully to Pfizer, Boehringer Ingelheim, and Sanofi.
In 2019, certain producers and pharmacies stopped selling the medication due to the belief that its active component, that is ranitidine, deteriorated over time and produced a substance called NDMA.
In 2020, the US Food and Drug Administration (FDA) removed all remaining brand name and generic Zantac drugs from the market.
The health regulator cited studies that showed that the quantity of NDMA rises according to how long Zantac products were stored, and could therefore become potentially unsafe.
Judge Rosenberg found that the allegations on Zantac could not be admitted in court as they “systemically utilised unreliable methodologies” and demonstrated “a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data”.
GSK said that after the 12 epidemiological studies held to look at human data about the use of ranitidine, the scientific consensus is that there is no reliable or consistent proof to back the allegation that ranitidine increases the risk of any cancer.