On Friday, the U.S Food and Drug Administration reported that Federal health officials have found an impurity in Zantac. It is Sanofi’s heartburn medications that cause cancer. The online pharmacy company, Valisure said it alerted the FDA that Zantac contains NDMA impurity.
David Light, CEO of Valisure, ” we’ve analyzed and seen every type and every manufacturer’s Zantac or ranitidine. The same type of problem is found in all the drugs which are very unstable and degrading. It is reacting to the human stomach and creating NDMA.”
After investigation, the FDA confirmed that the impurity is carcinogen called N-nitrosodimethylamine or NDMA. It is generally found in cooked or cured meat such as bacon and is an industrial byproduct. This carcinogen is found in medicines to treat blood pressure and heart failure since last year. This poses a low level of risk to the patients.
Light said that the company has used various techniques and found the same product in almost all drugs. With the approach of analytical technique, the company found one more carcinogen that is N-Nitrosodiethylamine or NDEA along with the NDMA.
Ranitidine: acidity and heartburn medication
Ranitidine medicine is used as an acidity and heartburn medication. It is generally prescribed by the doctors over the counter drugs. According to the FDA, The FDA never called individuals to stop the intake of Ranitidine. Patients, who are taking ranitidine prescription can discontinue its use after talking to its doctors.
The FDA said in a statement that NDMA is causing harm in the large amount. The level of harm is found from the preliminary tests which is not much higher than in common food.
Sanofi told CNBC in a written statement that for Sanofi patient’s safety is above all. We take it seriously and committed to working with the FDA.