US FDA Says Gastric Reflux Drug, Zantac (Ranitidine) Found To Contain Carcinogen
The US FDA has issued an alert as of yesterday that compound that causes cancer has been found in some ranitidine heartburn and gastric reflux and ulcer medicines, including the brand-name drug Zantac, and that investigations are underway. Patients anywhere in the world taking Zantac or Ranitidine are advised to contact their doctors or hospitals immediately.
Preliminary tests found low levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in products containing ranitidine.
NDMA is the same contaminant found in many brands of blood pressure and heart failure medicines in 2018, leading to numerous recalls.
Individuals who are taking prescription ranitidine and want to stop using it should discuss alternatives with their doctors, the US FDA advised. Those taking over-the-counter (OTC) ranitidine could switch to other OTC medicines immediately.
Several drugs are approved for the same or similar uses, the FDA noted.
NDMA is an environmental contaminant found in water and foods, including meats, dairy products and vegetables. It is classified as a human carcinogen.
"Drug impurities remain a major global concern. Zantac may prove safe in the long run, this latest statement adds confusion and concern, so my interim advice to patients is simple, switch immediately to another drug and of course, confirm with your doctor the need for an antacid." Dr. David Robbins, associate chief of endoscopy at Lenox Hill Hospital in New York City commented in a phone interview with Thailand Medical News.
Sanofi, manufacturer of Zantac, did not respond to a request for comment. So did other pharma companies producing generic versions.
The US FDA is working with international regulators and industry partners to find out where the contamination originated.
"The agency is examining levels of NDMA in ranitidine and evaluating possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation." commented Dr. Janet Woodcock, director of the US FDA's Center for Drug Evaluation and Research in another phone interview with Thailand Medical.
Large amounts of NDMA may pose a risk, but the levels of NDMA in ranitidine found in preliminary tests barely exceed amounts found in common foods, according to the US FDA.
Ranitidine decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn and gastric reflux, and prescription ranitidine is approved for a number of uses, including treatment and prevention of ulcers of the stomach and intestines, and treatment of gastroesophageal reflux disease. Individuals taking any of these products for these ailments are advised to contact their doctors or hospitals immediately to switch to alternatives as a precaution.
On the whole, many drugs associated with managing gastric reflux diseases have come under scrutiny in recent years as many are associated with long term complications. The worst are the class of drugs known as PPIs (Proton Pump Inhibitors). Thailand Medical News has done many articles about these in the past for example:
A better way to manage Gastric Reflux issues is to have proper dietary habits, no processed foods, lots of organic vegetables and fruits, lots of exercise and also activities like Yoga and Meditation and less stress. (but always consult a doctor and do not attempt to self medicate or self treat, based on articles online.) Read more here.
For more details about the carcinogenic effects of N-nitrosodimethylamine (NDMA), read here… https://www.atsdr.cdc.gov/phs/phs.asp?id=882&tid=173