Sanofi issued a position statement on the U.S. Zantac litigation.
On September 12, 2019, FDA stated that ranitidine-containing medicines, including Zantac, contain N-nitrosodimethylamine (NDMA) at low levels. The FDA further stated that the NDMA levels are more than the allowable limits in the tested samples.
Following this, Sanofi stated that it had recalled Zantac OTC products marketed in the U.S. and Canada.
Sanofi stated that the real-world evidence does not show any consumer harm from using Zantac. It further noted that the FDA and EMA had not found any reliable data showing ranitidine causes cancer.
Sanofi stated that it is confident about the defenses of the litigation. Along with Sanofi, GSK, Pfizer, and Boehringer Ingelheim were defendants.
The first trial in which Sanofi is involved is scheduled for February 2023.