European drug regulators have pushed back the deadline for drug companies to finish testing their products to detect an impurity known as NDMA, a probable human carcinogen, due to the coronavirus (COVID-19) pandemic. The EU gave drug companies a March 26 deadline to use a three-step process to test their over-the-counter and prescription drugs for NDMA after U.S. online pharmacy Valisure detected elevated levels of the impurity in several generic and brand-name heartburn drugs containing ranitidine, known by the brand-name Zantac.
But the drug companies reported challenges to meeting the first step in the deadline due to restrictions related to the coronavirus pandemic. EU regulators responded by pushing the deadline back six months to Oct. 1 for the first step of testing. Companies need only issue reports if they complete the risk evaluation or identify a risk in their products. The deadline delay will likely impact deadlines on subsequent steps in the testing process.
Valisure’s discovery of NDMA in ranitidine products led to sweeping recalls of the drug around the world. On April 1, the U.S. Food and Drug Administration (FDA) ordered the removal of all ranitidine products from the market after further testing and evaluation from third-party labs confirmed that NDMA levels in ranitidine increase even under normal storage conditions, including those the drug is exposed to during distribution and handling by consumers. Testing also showed that the older the ranitidine, or the longer the length of time since it was manufactured, the greater the level of NDMA. Both these factors may raise the level of NDMA above what the agency deems the acceptable daily intake limit.
Dozens of consumers are holding Zantac manufacturer Sanofi and other makers of ranitidine accountable, and have filed lawsuits against Big Pharma for putting profits ahead of patients. Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.