Valisure Accuses GSK of Defrauding Government by Selling Contaminated Zantac

PHILADELPHIA — Independent lab Valisure has sued GlaxoSmithKline in Pennsylvania federal court, accusing it of knowing that Zantac (ranitidine) can degrade into a carcinogen when stored at higher temperatures, but hid that risk for decades while government health plans paid prescriptions for the popular antacid.

In a May 20 amended whistleblower complaint filed in the U.S. District Court for the Eastern District of Pennsylvania, Valisure says GSK conducted experiments on ranitidine in 1981 which showed that the drug could form N-Nitrosodimethylamine (NDMA), but concealed the data from the Food and Drug Administration and doctors.

“When the FDA ordered GSK …