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You may have missed a warning issued by the FDA about one of the most commonly taken drugs.
There’s a good chance it could still be in your medicine cabinet, that’s just how popular its use is.
Promise me you’ll read everything below that you need to know and remove it from your home today….
Ranitidine in the news — again
Last year, the FDA declared that all ranitidine products should be pulled from shelves immediately.
Ranitidine is the active ingredient in a lot of OTC heartburn medications, including Zantac. It blocks your body from producing histamines, which keeps stomach acid production down.
But ranitidine-based medications were found to contain a concerning impurity called N-nitrosodimethylamine or NDMA. And it’s classified as a probable human carcinogen.
There were a couple of theories about how small amounts of NDMA got into the medications. One was that NMDA can form during certain drug manufacturing processes and when using certain ingredients. These include ingredients not intended to be in the final product that are not adequately “purged” during manufacturing.
Another was that in addition to contaminated raw materials, recycled materials (such as solvents or catalysts) being used in manufacturing may be causing the problems. These materials may not be adequately purified by the recycler, or they may come into contact with inadequately cleaned equipment during the process.
Nevertheless, at the time, investigators felt the levels weren’t high enough for an actual recall, and the FDA wasn’t even encouraging people to stop taking the drugs.
But the company that makes Novartis, the generic version of Zantac, decided to halt distribution to investigate the issue further. Even CVS Pharmacy planned to remove Zantac and its generic version from store shelves.
So, what’s different now — including these recent actions of the FDA?
According to the April 1, 2020 press release where the FDA requests removal of all ranitidine products (Zantac) from the Market, the agency has determined that newer FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.
The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.
How long have they been sitting in your medicine cabinet? Or the store shelves before you purchased them?
As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
Here are the steps being taken:
- The FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market.
- The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.
- Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.
And it’s important to note that, to date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec). Perhaps you can talk to your doctor about switching to one of these brands.
How concerned should you be about NDMA?
There’s no doubt among the scientific community that NDMA is a dangerous toxin. In fact, cancer researchers routinely use it to create cancer in laboratory animals, so they can study potential cures.
There aren’t many studies of whether NDMA causes cancer in humans, but it’s believed to be carcinogenic after chronic (long-term) exposure to even small amounts, and the federal government classifies it as an extremely hazardous substance under the Emergency Planning and Consumer Right-to-Know Act.
Common cancers linked to NMDA include:
- liver cancer
- pancreatic cancer
- lung cancer
- colorectal cancer
- esophageal cancer
- bowel cancer
- stomach cancer
This danger is why it is also important to dispose of the drugs properly. Low levels of NDMA are commonly ingested in the diet, for example, NDMA is present in foods, in soil and in water. So follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.
Natural solutions for heartburn
My colleague Dr. Mark Wiley offers tried and true natural remedies for heartburn and stomach acid problems. They are certainly worth a try:
Apple cider vinegar is a great prevention remedy for acid reflux. You can take 2 tablespoons in a glass of water 30 minutes before a meal to help normalize stomach acid and prevent indigestion. While many advocate drinking it at the time of heartburn, I have found this makes the symptom worse. However, when used before a meal it seems to prevent the issue.
Baking soda, or sodium bicarbonate, is perhaps the best remedy when you are experiencing GERD or acid reflux. This works by balancing the stomach pH when you drink ½ teaspoon in a cup of water. The taste is not terrific, but it works great.
For more tips on creating a lifestyle that prevents heartburn and more remedies for heartburn relief, check out another article he wrote, Refuge from acid reflux.
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- FDA Requests Removal of All Ranitidine Products (Zantac) from the Market — U.S. Food and Drug Administration