GlaxoSmithKline has decided that stopping distribution of its Zantac products just won’t cut it. The U.K. company has decided it is time to pull the ranitidine heartburn meds off of retail shelves.
The U.K.’s Medicines and Healthcare products Regulatory Agency Tuesday said GSK informed it that is recalling all unexpired Zantac prescription meds from pharmacies “due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.”
GSK, the original developer of the antacid Zantac, in an emailed comment today pointed out that it does not sell Zantac prescription or over-the-counter products in the U.S. Sanofi has U.S. rights to the brand. In the U.K., and elsewhere, though, GSK is retrieving the meds.
“As a precautionary measure, GSK has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zantac products in all markets. Patient safety remains our utmost priority and we are taking this issue very seriously,” the company said.
GlaxoSmithKline initially stopped distribution of the drugs after the FDA notified the public that it had learned NDMA was formed during the manufacturing of Zantac and its ranitidine generics. At the time, the agency said the amounts and attendant risks seemed small but that it was still investigating. NDMA is one of the potential carcinogens the FDA last year learned could also be formed during the manufacturing of certain sartan high blood pressure meds that led to a global recall.
Some drugmakers, like Novartis’ Sandoz, Apotex and Dr. Reddy’s Laboratories, went ahead and recalled their Zantac generics when the alert was first raised by the FDA. Pharmacy chains CVS, Walgreens, Rite Aid and Walmart, some of which have been sued for sales of contaminated blood pressure meds, also decided to strip their shelves of the over-the-counter antacids. The FDA has since reported that further tests found unacceptably high levels of the impurity in the drug prompting more drugmakers to initiate voluntary recalls.
The very first pharmacy to act was Valisure, an online retailer whose testing had determined that NDMA was present in ranitidine drugs. Valisure then filed a Citizen Petition with the FDA seeking to have the agency pull ranitidine drugs from the market and create viable tests for NDMA in them.
The FDA does not agree with using Valisure's “high temperature” testing but has developed its own method for drugmakers to test their own products.