The news broke on September 13, 2019 with a statement from the Dr. Janet Woodcock, the Director at the Center for Drug Evaluation and Research.
This is a day that will go down in history, at least for me. I’ll try to relay the facts without too much emotion, or any sensationalism because you’re getting enough of that if you’re reading other stories. But no lie, this is a difficult article to write because an unexpected cancer-causing compound has just been found in our generic supply chain for medication. Here’s the statement from Janet Woodcock, MD:
According to the statement, “The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”
You can learn more about WHERE the nitrosamines are, and how you might get exposed in this Toxicological Research ARTICLE published in 2015.
Zantac is one of the world’s most popular and effective antacids. Its generic “ranitdine” is sold by the millions! This is a favorite medication for many, and the first OTC drug to sell billions of dollars worth of sales. A testament to how well it works, and how many people sought it for heartburn.
Zantac manufacturer, Sanofi has responded in a statement that they take “patient safety seriously, and we are committed to working with the FDA.”
But it may be a day late and a dollar short. I say that because just a few hours ago, a class-action lawsuit was filed against Sanofi (and Boehringer Ingelheim) for possibly concealing risks for their popular heartburn medication Zantac. This has been filed in the U.S. District Court for the Northern District of California. The lawsuit accuses the makers of violating state consumer-protection laws by failuring to disclose the harmful levels of NDMA in their drug and continuing to sell the medication to the masses as an easy-to-find OTC remedy. True or not? Did they really know, or are they like deer in the headlights, like the rest of us?
This will be determined in a court of law. It’s not good to assume.
While I’m on the big pharma tangent, big news today regarding Purdue Pharma the makers of Oxycontin (opiate scandal)… well, they just filed for bankruptcy.
The suit alleges that Zantac contains a carcinogenic chemical at 26,000 times the threshold approved by the FDA. The OTC drug is manufactured by Paris-based Sanofi, whose American offices are in New Jersey. It previously was made by the famous German pharmaceutical firm Boehringer Ingelheim, who also has US offices. I’m sure everyone is sweating now but the lawsuit doesn’t mean their guilty. It just means that an investigation has to take place to determine what was known and if anything was hidden.
Enough about the makers, let’s talk about NDMA because millions of people for years might have been exposed, perhaps even you.
Exposure to NDMA is thought to raise risk for cancer, but like all carcinogens, it is dependent on the amount of exposure and the length of time exposed. Part of how this compound hurts a person is by rendering inactive 2 powerful antioxidant ‘cleansing’ enzymes in the liver. The first one being CATALASE, and the second one being GLUTATHIONE. These 2 enzymes are used to neutralize poisons in the body that you make during cellular metabolism, or that you inhale or ingest. These liver enzymes can help you clean up harmful heavy metals like mercury.
So you can see how important it is to avoid NDMA, and yet that is impossible! It’s in our drinking water, however less than 1 mcg per day.
When NDMA gets inside a person, whether it’s through ingestion of your pills, your food or from your cosmetics, then your ability to clean yourself up is compromised. Scientifically put, your ability to neutralize free radicals becomes hindered due to reduced antioxidants (catalase for example).
NDMA is toxic to the liver, which is termed “hepatotoxic.”
Down below, I have listed the human health impact and some symptoms to look out for. We get into NDMA unknowingly because it’s found in bacon and hot dogs, as well as some cold-cuts and cured meats like salami. It’s in pretty much any smoked food too, as well as cheese and beer. Another major exposure method is from tobacco smoke and chewing tobacco. It’s in some shampoos, facial serums and cleansers. But in our stomach medicine?! That’s so ironic because it’s hepatotoxic!
Recently, NDMA was found in some blood pressure medications – there was a recall with those! I’ll tell you more in a minute. Right now I’m going to focus on acid blockers like ranitidine which is sold in grocery stores, gas stations, and pharmacies worldwide.
The FDA is not issuing a drug recall yet, but rather advising that everyone remain on their medication. In other words, they don’t want you to panic and stop taking your medication, until they’ve fully evaluated whether or not the NDMA found in a handful of samples poses any risk.
You might be wondering how this whole thing started.
Traces of this carcinogen were found by a Connecticut lab who tested BOTH the brand name drug Zantac, and a few generic samples of ranitidine. They did not test every single brand that you see on the shelves of your local pharmacy. Furthermore, they did not yet publicly name the companies that they tested and found to contain the NDMA. So there’s a lot we don’t know.
But we know enough about it to put a warning out that NDMA was found in some samples and more research is needed.
Are All the Generics Contaminated?
There’s one manufacturer of the brand name drug called Zantac, which is available over-the-counter by Sanofi. The over-the-counter dose of 150mg Zantac is definitely a favorite of mine if you need an H2 blocking drug for acid reduction. It’s much safer in my opinion compared to cimetidine. You may not realize this, but higher dosages of Zantac (300mg) is available through the pharmacy and a prescription is required for this particular strength. This 300mg version is made by GlaxoSmithKline and FYI, they are not named in the class-action lawsuit, and this version has not been tested for any NDMA. I’m listing them only for completeness.
Zantac (ranitidine) is a medication that is FDA approved for this:
Gastric Ulcer
Dyspepsia
Esophagitis
Zollinger-Ellison Syndrome
Pyrosis (heartburn)
Multiple Endocrine Adenoma Syndrome
Systemic Mastocytosis
Duodenal Ulcer
Sometimes it’s also used for other indications, but it is not technically “FDA approved” for any of this:
Gastritis
Gastroesophageal Reflux Disease (GERD)
NSAID-induced Ulcer Prophylaxis
Aspiration Prophylaxis
So you can see there are a lot of people who are depending on this medication for their illness. I even thought about taking this medication myself for about 10 minutes during a bout of heartburn, but then I decided to go the natural route. You can read my story and get 5 Natural Remedies for Reflux and Esophagitis.
With generic Zantac, called “ranitidine” there’s more to the story.
When most people think of a generic drug, they think that there is just one generic manufacturer for that drug. But that’s not true at all. There are dozens of manufacturers of the generic version called “ranitidine.” CLICK HERE to see a few of the generics.
So there can be many companies (ie manufacturers) making a generic version of the brand drug. The fillers and colors of the tablet may change, and other little thing, however the active ingredient “ranitidine” should be the same exact strength and form as the brand Zantac.
Finding NDMA in a few samples does not mean that every single generic version of ranitidine is contaminated. I’m telling you this because as you can see HERE, there are dozens of makers for the generic ranitidine. I don’t know which are laced and which are not.
But for sure the generic makers aren’t always ethical, especially the ones who are producing our medication supply from overseas, without any supervision. Their quality control standards are at times, atrocious and I’m being polite. You can read about the recent problems with generics if you want to, I just wrote a comprehensive article about this mind-blowing problem because it’s shocking and you are entitled to know. My article is posted already and you can read it: Generic Meds May Not Be a Good Idea.
As for other H2 receptor antagonists that suppress acid exactly the way that ranitidine does… there isn’t anything to worry about yet because only Zantac and ranitidine were evaluated, not cimetidine (Tagamet), famotidine (Pepcid) or nizatidine (Axid). And not Zantac 300mg by prescription.
So all those are not part of this major breaking story. I will update you if need be.
You might be wondering how this was all discovered. Essentially, ranitidine came under scrutiny after Valisure, a New Haven, Connecticut-based online pharmacy that tests its medications prior to dispensing them (kudos to them!) alerted the FDA. According to Bloomberg “They found NDMA in both generic and brand versions of Zantac sold at major pharmacies run by companies including Walgreens Boots Alliance Inc., CVS Health Corp. and Walmart Inc.”
The trouble with NDMA began with bacon. Researchers have tested levels in the lean part of bacon and the fatty part of it. They tried microwaving it, frying, baking and broiling it too. The fatty part of the fried bacon has the highest amounts of NDMA. Hot dogs have come under fire too. But drugs?
Yes, and unfortunately, ranitidine is not the first drug to contain NDMA in it. In June 2019, the FDA issued a recall for 32 different lot numbers of a very popular blood pressure drug called losartan “over small amounts of carcinogen.” This medication belongs to the category of ARBs which stands for Angiotensin II Receptor Blockers. The presence of impurities in these drugs has caused millions of people to worry about a lot of things! For example:
Did you take enough of this medication over the years to cause DNA damage and get cancer?
How did it pass in the first place?
What will you take now if you can’t take your current medicine?
Will you be able to afford your new medicine, will it be covered by insurance?
Does it also have NDMA impurities, who can you trust?
Are there natural treatments for hypertension and will they work?
The FDA issued this statement regarding the ARBs:
“We initially estimated that if 8,000 people took the highest valsartan dose (320 mg) containing N-Nitrosodimethylamine (NDMA) from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of those 8,000 people. In reality, the vast majority of patients exposed to NDMA through ARBs received much smaller amounts of the impurity than this worst-case scenario, and, since not all ARBs are affected, it’s very likely that a patient taking an ARB for four years would not have always received one of the affected products.”
And that was just for the hypertension medications where millions of people could be taking pills that were tainted with the same cancer-causing agent in heartburn medicine!
Why so much NDMA in our generic supply chain? That’s a good question. It’s honestly head-scratching and this is where I have to reign myself in. But you can ponder it yourself: Where are ALL the stringent protocols and quality assurance procedures that are supposed to protect you as a consumer from harmful medicien? You have enough to deal with, with just the side effects, forget about the cancer-causing contaminants!
The NDMA problem sparked a worldwide recall of blood-pressure pills this year. And I predict it’s going to be a similar scenario for heartburn medicine. This is a ‘stomach drug’ meaning it’s intended use is to reduce acid. It’s not generally thought of as a life-saving kind of pill. Finding NDMA in some batches might cause some of you to pause, and others to continue taking the medication until further research elucidates exactly how much of a problem it is to the human body.
It’s a good time to be prudent, so here’s my advise. If you are not dependent on your heartburn medicine, consider some natural alternatives that could suppress acid and/or coat and soothe your stomach. I have those articles posted at my website, here are a few links:
Boswellia Reduces Pain and GI Symptoms
Licorice Helps Chronic Fatigue and Heartburn
6 Amazing Benefits of Papaya and Papain
Heartburn: My Gut Feeling is You Need More Acid
5 Natural Remedies for Reflux and Esophagitis
I specialize in alternative remedies that work similarly to medication but without the side effects, so please read some of those articles above.
One more thing regarding the PPI drugs such as Prilosec, Nexium and Prevacid. These medications have not been found to be contaminated with NDMA. At least not yet! They appear to be clean and these are in a totally different category as ranitidine. Be aware that taking them can cause serious nutrient depletions of your minerals, especially magnesium. It’s just a typical, expected side effect due to increasing pH in the gut. Taking antacids causes a natural reduction and what I call ‘drug mugging’ of magnesium. Again, no NDMA has been found in PPI medications.
Signs and Symptoms of NDMA Toxicity
Everyone experiences things differently, and of course, having been exposed does not mean that you will experience any of these, however to be complete, here’s a list of potential signs and symptoms of NDMA toxicity. I got this information from the Toxicology Data Network:
Nausea
Vomiting
Diarrhea
Abdominal cramps
Headache
Enlarged liver
Abnormal liver function tests (reduced liver function)
Enlarged liver
Reduced glutathione and catalase activity
Kidney damage
Breathing problems
Generalized malaise
Fever
Suzy Cohen, has been a licensed pharmacist for over 30 years and believes the best approach to chronic illness is a combination of natural medicine and conventional. She founded her own dietary supplement company specializing in custom-formulas, some of which have patents. With a special focus on functional medicine, thyroid health and drug nutrient depletion, Suzy is the author of several related books including Thyroid Healthy, Drug Muggers, Diabetes Without Drugs, and a nationally syndicated column.
