Traces of Carcinogens Found in Generic Zantac Lead to Global Halt in Shipment
September 26, 2019 in Product Liability
As a result of the discovery of the cancer-causing N-nitrosodimethylamine (NDMA) found in Zantac, manufacture and shipment of both the generic and branded forms of Zantac have been halted by Sandoz, Novartis and GlaxoSmithKline Plc. Here, the pharmaceutical liability attorneys at Sullivan Papain Block McManus Coffinas & Cannavo P.C. discuss recent updates to this global halt in distribution and what it means for manufacturers and consumers.
Zantac and Its Generic Counterparts Used as a Histamine-2 Blocker
Ranitidine, which is also sold under the brand name of Zantac, is a popular over-the-counter and prescription antacid and histamine-2 blocker that is used to treat and prevent heartburn, stomach ulcers, gastroesophageal reflux disease (GERD) and more. Ranitidine can be used to treat these conditions by reducing stomach acid levels.
Zantac Found to Have Low Levels of NDMA
Drug manufacturers Sandoz, Novartis and GlaxoSmithKline Plc have ceased the distribution of Zantac in response to the recent detection of the cancer-causing impurity NDMA in the drug. According to the U.S. Food and Drug Administration (FDA) as well as the European Medicines Agency, recent tests showed the presence of NDMA, a probable carcinogen, in generic Zantac, which could potentially pose a risk to patients taking it.
Novartis and GlaxoSmithKline Plc recently decided to halt the global distribution of Zantac until further notice. Unlike these companies, another major drug manufacturer, Sanofi, decided not to halt the manufacture and distribution of ranitidine outside of Canada.
Carcinogen-Tainted Ranitidine Resembles Contamination of Valsartan Last Year
The recent discovery of traces of NDMA in ranitidine reflects the global recall of other pharmaceutical drugs that occurred last year. NDMA was also found in valsartan and losartan, which are antihypertensive drugs used to treat high blood pressure and heart failure. The detection of NDMA in these pharmaceutical blood pressure medications eventually resulted in a global recall.
Currently, the FDA has not issued a recall of Zantac and its generic counterparts, but has stated that additional testing is required to determine whether or not the drugs contain dangerous levels of NDMA. You can read the full FDA report here.
Consult the Team of Product Liability Attorneys atSullivan Papain Block McManus Coffinas & Cannavo P.C. Today
The alarming discovery of the carcinogen NDMA in ranitidine could have potentially significant effects on a large population of patients that take the drug to treat their heartburn and other conditions. If you have taken or currently use Zantac or other forms of ranitidine to treat your esophageal or stomach condition, it is advisable to contact your physician immediately. In addition, if you or a loved one has taken ranitidine, valsartan, losartan or another drug that has been discovered to have low levels of NDMA, consult the team of pharmaceutical liability attorneys at Sullivan Papain Block McManus Coffinas & Cannavo P.C. today.