Here we go again. First, blood pressure medications called angiotensin receptor blockers - specifically valsartan, losartan and irbesartan - were recalled because of a potential carcinogenic contaminant, a nitrosamine impurity called N-nitrosodimethylamine (NDMA). Now the same contaminant has been found in tummy-soothing antacids that treat heartburn and GERD, such as over-the-counter and prescription Zantac. As a result, the manufacturer, Sanofi, has withdrawn the product completely from shelves in the U.S. and Canada. But that's not the end of the problem. There's an ongoing debate about whether the active ingredient in Zantac, ranitidine, is an unstable molecule that degrades and produces NDMA or whether the trace carcinogen is imposed on the medication through faulty manufacturing practices. The Food and Drug Administration says the latter, but Valisure, the online pharmacy that conducted the purity tests and determined that there was NDMA present in ranitidine samples (bravo for them), says otherwise. As of this writing, the exploration of the problem continues.
So where does that leave you and your heartburn?
The good news first: It's estimated that only one person in 8,000 would develop cancer (largely bladder cancer) from taking a daily dose of 150 milligrams of ranitidine for 10 years. So taking the antacid VERY INFREQUENTLY seems very safe.
The smart move: If you are prescribed ranitidine or Zantac, don't stop taking it without talking with your doctor and obtaining an alternative such as Pepcid or famotidine. If you take over-the-counter ranitidine, make the switch to antacids that do not have the NDMA problem. (Don't flush your old meds, they pollute water and harm marine life. Take them to a pharmacy for disposal.)
Why is there this problem? We have been hearing about quality control lapses in overseas drug manufacturing for years: In 2014 (10 years after a whistleblower alerted the FDA) a company named Ranbaxy, in Punjab, India, was banned from marketing drugs in the U.S. because of quality issues. That was after its subsidiary Ranbaxy USA pleaded guilty to selling adulterated drugs and lying to the FDA about it - and paid $500 million in fines.
Clearly, generic and brand drug manufacturing oversees makes quality control by the FDA more difficult. Here, inspections are without notice, so companies have to be in compliance all the time. Oversees, companies get months of notice before inspectors show up. The result is fraud.
Given the problems with generics from India and China, Dr. Mike says it is a pretty good bet the problem is bigger than one or two drugs. An incident from the Cleveland Clinic (they're very careful about the generics they prescribe and have a do-not-use list) illustrates what can happen. A patient who had a successful heart transplant began rejecting the organ months later. When docs investigated, they found that the brand-name anti-rejection drug the patient had been taking, called Prograf, had been switched (not by the surgeon!) for a generic manufactured in India. According to experts at the Cleveland Clinic, some generics aren't a close enough match to the brand and even a small variance in the composition of the drug may be risky for some patients.
Med solutions: Use a pharmacy like Valisure that tests the medications they ship to you. Refuse generics from India and China. Ask to be prescribed generic drugs made in the U.S. or Canada - they exist! Or ask your doctor to prescribe only brand-name drugs.
Beating heartburn without meds: Eat slowly and wisely. Smaller meals can help avoid acid reflux, so try grazing! Experiment with cutting out potentially upsetting fatty and spicy foods as well as mint, tomatoes, onions, garlic, coffee, tea, chocolate and alcohol from your diet. Add them back in one at a time and see if any are your culprits. Sleep on an incline (gravity is your friend), and do not lie down after a meal. Ask your doc if other meds you take could be the source of your problem.
Distributed by King Features Syndicate, Inc.