Pharmaceutical companies like GSK, Sanofi and Haleon saw a sharp sell-off of their shares in US markets over fears of potential litigation charges by US authorities over the heartburn drug Zantac. Legal proceedings are expected to start on August 22, even as issues over the drugs have been there since 2018-19.
The drug was developed by GSK in the 1980s. It was initially a prescription drug before it was made available over-the-counter. In 2019, the drug faced a safety review when reports emerged that ranitidine (the drug name for Zantac) contained NDMA, a possible carcinogen. As the patent over the drug expired in 1997, the drug was taken up by multiple manufacturers.
By 2020, the US Food and Drug Administration and the European Medicines Agency had requested all versions of the drug to be pulled out of markets. The drug remains available in India with no particular directives from the Central Drugs Standard Control Organisation (CDSCO), though GSK has stopped selling the drug in the country even as other pharma companies still sell the drug.
As a result of the US FDA call for recall, over 2,000 cases have been filed against various drugmakers. The first case is set to begin on August 22 even as the major trials will start in 2023.
“The overwhelming weight of the scientific evidence supports the conclusion that there is no increased cancer risk associated with the use
“As disclosed in our filings with the U.S. Securities and Exchange Commission since February 2020, a number of lawsuits have been filed against many defendants, including Pfizer, involving Zantac,” said major drugmaker Pfizer. The company stated that it only sold Zantac products between 1998 and 2006 and the 2019 withdrawal didn’t affect any Pfizer products.
