GSK: FDA, EMA Conclude No Evidence Of Association Between Ranitidine Therapy And Cancer Development
British drug maker GSK plc (GSK,GSK.L), in its statement on Zantac (ranitidine) litigation and N-nitrosodimethylamine or NDMA, said the U.S. and European regulators have concluded there is no evidence of a causal association between ranitidine therapy and the development of cancer.
The company noted that substantial scientific evidence supports the conclusion of the U.S. Food & Drug Administration, and the European Medicines Agency.
GSK said the plaintiff litigation is inconsistent with the scientific consensus, and that the company will vigorously defend all claims.
The statement was issued in response to recent speculative commentary regarding U.S. Zantac litigation.
GSK has been named as a defendant in around 3,000 filed personal injury cases in federal and state court and numerous unfiled claims registered in a census established by the Court presiding over the Zantac Multidistrict Litigation (MDL) proceeding.
Since the issue concerning the presence of NDMA in ranitidine arose in 2019, GSK noted that the company, independent cancer researchers, the FDA and the EMA have all undertaken extensive reviews of available data and conducted numerous investigations.
Based on these investigations and experiments, all have concluded that there is no evidence of a causal association between the therapy and the cancer development. These conclusions pertain to all forms of cancer.
In November 2019, the FDA determined that levels of NDMA in ranitidine products are similar to levels in common foods like grilled and smoked meats, and that it would conduct tests to fully understand if ranitidine forms NDMA in the human body.
In September 2020, the EMA’s comprehensive review of epidemiological and post marketing data concluded there is “no evidence of a causal association between ranitidine therapy and the development of cancer in patients.”
In June 2021, the FDA reported that its testing did not support that ranitidine is converted to NDMA in a general, healthy population.
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