The United States Food and Drug Administration has said that US federal health officials have discovered that an impurity found in Sanofi’s heartburn medication Zantac has the potential to cause cancer.
This was reveled after a probe in the issue following an alert to the FDA that was filed by Valisure, an online pharmacy company, about its discovery of NDMA in Zantac.
Since the last one year, investigation into the carcinogen, called N-nitrosodimethylamine or NDMA, in medicines for blood pressure and heart failure, was being carried out by the FDA and was also evaluating whether patients were at risk because of low levels of the carcinogen, the US regulatory body said.
“The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” the FDA said in the statement.
Stomach acidity and heartburn is generally treated by Ranitidine medicines and are mostly available over the counter as well as through prescriptions.
“Sanofi takes patient safety seriously, and we are committed to working with the FDA,” Sanofi said in a written statement to the media. The Zantac over-the-counter medication “has been around for over a decade and meets all the specified safety requirements for use in the OTC market.”
Although it is known that humans can be harmed by consumption of large amounts of NDMA, the FDA confirmed that the levels that it has found in the medicine based on preliminary tests are not much higher than what is commonly found in the regular foods that humans consume.
A petition seeking an order to recall and suspend sales of ranitidine had been filed by Valisure with the FDA.
“Every manufacturer and every type of Zantac or ranitidine that we’ve analyzed seems to have the same problem of the drug itself being very unstable and degrading, or even potentially reacting to, the condition in the human stomach to create NDMA,” said David Light, CEO of Valisure.
Samples of every batch of every medicine it dispenses is analyzed by the pharmacy company, Light said, and added that the analytical techniques used for analysis and screening by it for NDMA and N-Nitrosodiethylamine or NDEA, another carcinogen are according to the recommendations of the FDA.
“We’ve been trying to be very proactive in terms of not just looking where everyone else is looking,” Light said.
There has been recall of several blood pressure drugs which have already been found to contain NDMA.
For example, products that contain losartan, which is used for treatment of high blood pressure, were recalled by Torrent Pharmaceuticals and Camber Pharmaceutical earlier this year after the substance was found to be contained in the medicines. For the same reason, recall of its heart medication would be expanded by Israel-based Teva Pharmaceuticals, the company said.
The presence of cancer-causing chemical dimethylformamide in the medicine for blood pressure called valsartan was found by Valisure, the pharma company told the FDA in June this year. Valsartan is manufactured by Swiss drugmaker Novartis and other pharmaceutical companies.
(Adapted from CNBC.com)