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Ranitidine and the brand name drug, Zantac, have been on the market since the early 1980s when GlaxoSmithKline released it for the treatment of gastritis and gastroesophageal reflux disease (GERD). If you have been paying attention to the news lately, concern is being raised over whether or not ranitidine has a role to play in causing pancreatic cancer.
Ranitidine is part of the class of drugs called H2 blockers or histamine type II blockers. These drugs block the secretion of stomach acid in an attempt to alleviate symptoms of burning from the acid either being overproduced or refluxing up into the esophagus where it's not supposed to be. Zantac is the best-selling drug of all time and has been around for over 25 years. How are we just now discovering problems with it?
The problem isn’t really with the drug itself but rather an impurity in the tablets from the manufacturing process. The impurity making all the trouble is N-nitrosodimethylamine (NDMA), which has been found to be linked to cancer in humans.
The FDA, Federal food and drug administration, has been evaluating the issue since this summer and released this statement 2 days ago. “The agency has tested numerous ranitidine products on the market over the past few months, and today we’re releasing a summary of the results we have to date. Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats. We also conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of these tests indicate that NDMA is not formed through this process. Similarly, if ranitidine is exposed to a simulated small intestine environment, NDMA is not formed. However, we still must test the drugs in the human body to fully understand if ranitidine forms NDMA.”
If you go to certain websites representing certain legal offices, however, you will find a much different account of the results. The FDA states that the NDMA in “some” brands of ranitidine are higher than they allow but are still in the range of what you can get from smoked or grilled meats. Scary drug lawsuit websites claim that the levels of NDMA found are 26,000 times more than the allowed amount. The FDA has looked into why some of these third-party testing sites found such high levels of NDMA when they tested the ranitidine tablets and the reason is bad lab testing. These labs did not test as they should have but reported the results anyway. Unfortunately, this breeds confusion, mistrust, suspicion and faulty conclusions.
So why are the manufacturers and the FDA recommending that ranitidine and its brand name drug, Zantac, be pulled from the shelves? Because of widespread panic. It makes sense for the public to be able to maintain trust in the agency tasked with overseeing drug safety, the FDA, and the pharmaceutical manufacturers, Sanofi-Aventis and others must show that they are listening to public concerns and taking the prudent course of pulling the drug while they look into the matter. The FDA still has additional testing it wants to do before making a final judgement, but for now its findings do not seem to indicate that there is a clear breach of manufacturing norms in the case of ranitidine or such high levels of NDMA that patients should be having cancer concerns. Not yet, anyways. There may ultimately be some changes made to the production process for some manufacturers, but I think ranitidine will be back on the market and available to the public next year.
Now you know I do not have any special place in my heart for big pharmaceutical companies but if it turns out that the issue here was blown out of proportion and a rush to judgement was made based on poor science and bad lab procedures then a good medicine’s image was improperly damaged forever and the public is once again left wondering who to trust. Doctors struggle everyday trying to overcome the damage done by one bad study in England regarding autism and its link to the MMR — which does not exist. I don’t know if we will ever completely overcome that debacle. Luckily in the case of ranitidine there are plenty of alternative medicines patients can turn to. Talk it over with your physician. Discuss your options. Keep an open mind. Stay tuned, we should know more over the next few months about ranitidine’s future.
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Dr. John Turner is a family medicine and emergency medicine doctor with 25 years of experience. He is also the owner of My Primary Care Clinic and My Emergency Room 24/7 here in Hays County. Dr. Turner may be reached at 512-667-6087.
