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Harvard Health Blog
Ranitidine (Zantac) recall expanded, many questions remain
- By Joshua Gagne, PharmD, ScD, Contributor
Update: On April 1, 2020, the FDA requested manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs (Zantac, others) from the market immediately, due to the presence of a contaminant known as N-Nitrosodimethylamine (NDMA). Although the FDA did not observe unacceptable levels of NDMA in many of the samples they tested, they have determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures. As a result of this recall, ranitidine products will no longer be available for prescription or OTC use in the US.
The FDA is also advising consumers taking OTC ranitidine to stop taking this medication, including any unused ranitidine medication they may still have at home. Other FDA-approved OTC medications are available to treat heartburn. Patients taking prescription ranitidine should speak with their doctor about other treatment options before stopping the medicine.
As anticipated, recall of the popular heartburn medicine ranitidine (Zantac) has expanded. But we still have more questions than answers.
As I mentioned in my original blog post on this topic, the online pharmacy Valisure, which originally alerted the FDA to the issue, found what they called “extremely high levels” of the probable cancer-causing substance N-nitrosodimethylamine (NDMA) in ranitidine products.
The FDA has indicated that its own preliminary testing has detected low levels of NDMA in ranitidine.
Testing methods may have influenced NMDA results
The FDA has clarified that the testing method that found the “extremely high levels” of NDMA applied high heat, at a level much higher than normal body temperature. In other words, the testing did not reflect typical conditions under which the medication would be stored or taken.
The FDA is asking all companies that manufacture ranitidine, as well as other similar medications (both H2 blockers, the class of drugs to which ranitidine belongs, and proton-pump inhibitors, or PPIs, a different class of drugs used for similar conditions), to test their products using lower heat closer to normal body temperature. So far, there is no indication that these other products are affected; the FDA is likely asking for these tests only as a precaution.
As of now, the FDA has allowed ranitidine to remain on the market. Still, some manufacturers have issued voluntary recalls and some pharmacies have pulled it off the shelves.
FDA estimates ranitidine NMDA risk with other medications
The FDA has not yet released the results of its own tests of ranitidine. But they previously estimated the likely impact of NDMA found in another class of medications, called angiotensin receptor blockers, on the risk of cancer. That estimate provides some context for the current circumstances.
Angiotensin receptor blockers, including the drug valsartan (Diovan), are used to treat high blood pressure and other heart conditions. They were recalled beginning last year due to the presence of NDMA and other related impurities. The FDA estimated that, if 8,000 people took the highest dose of valsartan containing NDMA every day for four years, there would be one additional case of cancer over the lifetimes of these 8,000 people.
Currently, we do not know how the amount of NDMA found in ranitidine compares to the amount found in valsartan.
Until we know more, the best course of action if you are taking ranitidine is to talk to your doctor about whether treatment is still needed. For some conditions, the benefits likely outweigh the risks. Although some ranitidine products remain available, consider alternative medications such as cimetidine (Tagamet) or famotidine (Pepcid) if you need long-term treatment.
Follow me on Twitter @JoshuaJGagne
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Comments
Omeprozole almost destroyed my kidneys, now they are taking Ranitidine off the market, and the other H2’s don’t seem to help like Ranitidine did. That means I’m going to be in great distress from the acid. Will this ever come back on the market?
Zantac is the ONLY medication that works for me that doesn’t have unbearable side effects. There must be many more people like me. Now what are we supposed to do? Why can’t the prescription Zantac stay on the market so doctors can let people have it when nothing else works?
I had been taking generic Zantac for 20 years. I was diagnosed with bladder cancer in 2015. Side effect of Zantac? Fortunate, 5 years now cancer free.
I to have been taking Zantac for close to 20 years , was quite disappointed to see it disappear, without any regard for the population that rely on it’s daily Relief from acid build up.
I will endeavour to source the old product Tagamet.
excellent
What I don’t understand, is shouldn’t the FDA also be held responsible? I mean it’s there job to catch this BEFORE a drug is on the market, not years later. Are they going by the honor system now?
I had acid reflux for years and took prilosec for many years and noticed the reflux went away after I quit drinking coffee and daily exercise. The I started drinking coffee again and stopped exercising and the reflux came back. Now they pulled Zantac so I am going back to exercise and stopping coffee. For quick relief during a reflux attack I found that whole milk works great and a big glass after a meal also helps a lot.
Thank you a lot John. I was about to destroy all my ranitidine until i read your comment. The pills sre actually good amd help with my acid reflux but i gotta change my diet i dont like relying on meds to make me feel better.
Let me see if I’ve got this right: An unknown online pharmacy’s testing lab thinks that there MAY be a link to an ingredient found in Zantac, which is an OTC drug for heartburn and acid issues in the stomach (aka an acid reducer), and cancer.
So ALL the retailers of the drug, which is sold to millions of Americans BECAUSE IT WORKS, pull the drug AND all of its generic equivalents, OFF THE SHELVES virtually overnight?
Well, folks, in case you haven’t noticed yet, there are certain global entities that seek to pull all effective medication off the shelves. It’s called de-industrialization. Anything that works, they want pulled.
And then they can replace these drugs with those that don’t work, cost more, and really do give you cancer.
I’ve been taking ranitidine (equate brand) for over 10 years b/c I have 3 ulcers in my stomach. Ranitidine actually works, and works well.
John I totally agree. So when and where will this product be back in production ? I recently got off of a ppi, had massive withdrawals. But God got me through it. Two days of hell. I am better now. I will never go back to ppi’s. So many side effects too. I guess tagamet or pepcid. Ty for your comment. Good one. I agree it’s all insane.
What about the infant liquid Zantac that is prescribed for acid reflux. This has not been mentioned in the FDA report, and hasn’t been recalled. I can assume it’s made of the same chemicals. My doctor or pharmacist can’t advise either way. Have there been any additional research performed on the infant medication?
I take it that nobody from Canada 9r the FDA have ever suffered with acid reflux or Herd, because if you had you wouldn’t recommend Crap like fimotidine or tums, only zantac or its OTC counterpart works for me, I need fast acting . I take omeprezole but it doesn’t stop the reflux and here attacks that close 0ff my airway. When will it be back on the shelves for sale? I thought this was a voluntary recall, but that is not the case because every store has taken the product off the shelves over the past few weeks. I take around 900mg otc ranitidine a day. Without it. I can’t eat or drink anything just small sips of water throughout the day.
Gerd is what I said in previous post I didn’t realize spell check changed it.
Ranitidine is used regularly by sufferers of interstitial cystitis. I was using it for several months as needed.
I have been taking Zantac for years (after switching from omeprazole)–so I am curious to know if there are any tests developed yet to measure any cancer effects?
Mate they still haven’t confirmed if Zantac contains NDMA in original form they have found it after preliminary test but these test exposed the drug to higher temperature than your body would when digestion occurs it is a worry but need to wait for results of test using actual conditions,
I have no valve on the top of my stomach so have been on ppi for years.
I was taking zantac for over eight years from 1998 to 2006.
What are my chances of getting cancer this long after stopping?
I have normally low blood pressure but 156/111 was taken two days ago. I have noticed that my blood pressure has been gradually increasing since I started taking zantac 150 about 10 yrs or so? I thought it was because I was getting older, so now I wonder if it was from taking zantac twice a day for years?
You’re placement of question marks after making a statement makes your comment not clear.
I’m not sure if the side effects of this medication. If you normally have low BP then when did the high start? You said it’s been increasing for 10 years but yet you have low BP? You should definitely talk to the Dr who prescribed you the medication
I’ve only taken two bottles of this drug.
Should I be concerned?
In France they have just recalled cimitindine too & they have also stopped making famotidine. I have taken ranitidine for 15 years now for mast cell activation syndrome with predominately gut reactions. There are no type 2 histamine blockers left on the market. It’s extremely worrying.
Yes! Very frightening! What are those of us with these conditions to do?
FDA is subtle in their approach towards the recall because of their apparent subjective affiliation with the Multibillion Pharmaceutical companies from which they benefit
L. Boesing I’m thinking the same thing and I take a med that makes me extremely hot all day. I also live in Florida, hot and I carry my med in car just in case. I fly2 times a month; bag in lower plane and drive several hrs a lot to see daughter with my bags in trunk. Need to know were does cancer start in body so I know to check often, or does ca-125 blood test pick it up
Why has sobeys got all kinds of. Zantac on the shelves today
It’s voluntary, as per article.
I am still a little confused . Was Zantac brand over the counter contaminated as well ? Or was the The contamination isolated to prescription Zantac and over the counter ranitidine. Different articles say different things.
There is no one Zantac brand different companies put it out under that name . The one I have is Sanofi, I’m calling the number on the bottle to see if I can get any more info.
Well well well, my ex doctor had me on the absolute highest dose of ranitidine at 300 mg a day, listen to 4 I’m not sure how many years, although at 59 they did remove a sessile polyp and an adenoma during my colonoscopy this year, he always thought the best was the highest dose oh, also I was on valsartan, then I’ll have to check to see how long I was on that time I was on the stomach medicine for a long time, when I left him I went on to 150 from the store. So if I was only supposed to be on it for a short. Of time that wasn’t the case here. what worries me is what they removed from me now and how much more often I have to have a colonoscopy.
Most blood pressure medications or room temperature medications are shipped in only bags all year round. The trucks reach temperatures of over 150 degrees. Mailboxes also reach these higher temperature extremes of over 120 degrees on a 90-degree day. Does NDMA increase with higher temperatures?
Yes. If you review the citizens petition filed by Valisure, you will see that Ranitidine breaks down into over 3,000,000 nG of nDMA per tablet (the FDA only allows 96 nG per tablet). You should check out ZantacCancer.com.
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