Novartis Halts Distribution Of Popular Heartburn Drug

Novartis AG’s (NYSE: NVS) Sandoz unit is halting distribution of popular heartburn drugs containing ranitidine because they may be contaminated with a cancer-causing chemical. The company said that it is halting distribution of its versions of the drug in all its markets, including the United States and Canada, until further notice as a precautionary measure. Certain medications containing ranitidine have been found to contain low levels of NDMA, or N-Nitrosodimethylamine.

Ranitidine is an over-the-counter and prescription histamine-2 blocker, which decreases the amount of stomach acid. Branded versions of the drug, such as Sanofi’s Zantac, are available for over-the-counter sale while generic versions are available for sale both OTC and with prescription. According to a statement from the U.S. Food and Drug Administration, “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.”

A distribution halt is different from a recall and means that the existing stock of the drugs in pharmacies or stores can still be sold. Some versions of Zantac have been recalled in Europe and Canada due to the impurities. The FDA is currently working with international regulators and industry partners to determine the source of the contamination.

Neither the FDA nor the European Medicines Agency have asked patients to stop taking the drug. In its statement, the FDA said that they’re not suggesting people stop taking ranitidine medications at this time. The agency is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and said it will share the information when it is available.

Those who wish to discontinue using prescription heartburn medications with ranitidine at this time should reach out to their healthcare provider for other treatment options. This is not the first issue involving NDMA to come to light this year. Last June, the popular blood pressure medication losartan was recalled after trace amounts NDMA were found in the drugs.