Possible cancer risk from ranitidine

FDA: Some Ranitidine Products, Like Zantac, Contain Probable Carcinogen

By Amy Orciari Herman

Edited by
- Susan Sadoughi, MD, and
- Andre Sofair, MD, MPH

Some ranitidine products, including some sold under the brand name Zantac, contain low levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA), the FDA cautioned on Friday.

NDMA is an environmental contaminant that's considered a probable human carcinogen. It gained widespread attention in the summer of 2018, when it was detected in some lots of the angiotensin-receptor blocker valsartan, leading to product recalls.

In a news release, the FDA said that it "is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients." The agency is not currently asking people to stop using the drug. Rather, it advises the following: "Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition."

Link(s):
FDA MedWatch safety alert (Free) http://response.jwatch.org/t?ctl=63ACD:5FF9B588B7CB016C46FE6632B933F058D2B71D9A95FA21D3&

FDA news release (Free) http://response.jwatch.org/t?ctl=63ACE:5FF9B588B7CB016C46FE6632B933F058D2B71D9A95FA21D3&

Background: NEJM Journal Watch Cardiology coverage of ARB recalls over NDMA and other contaminants (Your NEJM Journal Watch subscription required) http://response.jwatch.org/t?ctl=63ACF:5FF9B588B7CB016C46FE6632B933F058D2B71D9A95FA21D3&

 

from Physician's First Watch again:

Ranitidine Tests Find "Unacceptable" Levels of NDMA

By the Editors

The FDA says that its early tests have found "unacceptable levels" of the probable carcinogen N-nitrosodimethylamine (NDMA) in ranitidine (Zantac and generics), a histamine-2 receptor antagonist.

The agency also noted on Wednesday that testing protocols used by third-party labs have used a high-temperature procedure for ranitidine and angiotensin II receptor blockers. With ranitidine, these high temperatures actually create NDMA. Instead, the agency recommends lower-temperature tests for this drug.

While not all ranitidine medications have been recalled, pharmacies like Walmart, CVS, and Walgreens have pulled over-the-counter ranitidine from the shelves during the investigation.

Link(s):
FDA update (Free) http://response.jwatch.org/t?ctl=65C00:5FF9B588B7CB016C129C51966938BB5DD2B71D9A95FA21D3&
Reuters story (Free) http://response.jwatch.org/t?ctl=65C01:5FF9B588B7CB016C129C51966938BB5DD2B71D9A95FA21D3&
Background: Physician's First Watch coverage of ranitidine recall (Free) http://response.jwatch.org/t?ctl=65C02:5FF9B588B7CB016C129C51966938BB5DD2B71D9A95FA21D3&

 

Health Canada has recalled several brands of Ranitidine - both over the counter and prescription.

 

I just got an email from my doctor recommending that all his patients stop taking ranitidine.

For those people who are currently taking ranitidine and wish to replace it with an equivalent, safe H2 blocker, famotidine (Pepcid) can be an excellent choice. Like ranitidine, its side effects are minimal. It takes a little longer than ranitidine to take effect, but overall, it's rated as being more potent.

 

from yesterday's Physician's Health Watch:

FDA: OTC Ranitidine Alternatives Don't Contain NDMA

By the Editors

The FDA says that alternatives to over-the-counter ranitidine don't appear to contain the same potentially carcinogenic substance as ranitidine.

Several lots of OTC ranitidine have been recalled because of the presence of small amounts of N-nitrosodimethylamine (NDMA), a probable human carcinogen. The most recent recalls include all brand name OTC Zantac, as well as some generic products labeled by Walgreens, Walmart, CVS, Target, and Kroger.

Meanwhile, preliminary tests haven't detected NDMA in other heartburn medications, including famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec).

Link(s):

FDA update (Free) http://response.jwatch.org/t?ctl=68398:5FF9B588B7CB016C4D905EF23D0F820BD2B71D9A95FA21D3&

Background: Physician's First Watch coverage of Zantac recall (Free) http://response.jwatch.org/t?ctl=68399:5FF9B588B7CB016C4D905EF23D0F820BD2B71D9A95FA21D3&

 

NDMA in Ranitidine Similar to Levels in Grilled Meats, FDA Says

By Amy Orciari Herman

Edited by
- Susan Sadoughi, MD, and
- Andre Sofair, MD, MPH

Levels of N-nitrosodimethylamine (NDMA) in many tested ranitidine products are similar to those consumed through "common foods like grilled or smoked meats," the FDA said on Friday. Beginning in September, numerous ranitidine products have been recalled owing to high levels of NDMA, a probable human carcinogen.

The acceptable daily intake limit for NDMA in ranitidine has been set at 0.096 micrograms or 0.32 ppm. The FDA is asking manufacturers to recall all products that exceed these levels. It's also asking manufacturers to recall any nizatidine that has unacceptably high NDMA (nizatidine is chemically similar to ranitidine).

Additionally, the FDA conducted simulation tests to see what happens to ranitidine when exposed to gastric and intestinal fluids. The agency found that no additional NDMA forms in these environments, although tests in the human body are warranted.

The FDA says its recommendations for patients remain unchanged:
-- Those using OTC ranitidine or nizatidine "can consider" using OTC alternatives, like famotidine or omeprazole.
-- Those using prescription ranitidine or nizatidine should talk with their clinicians about other options.

Link(s):
FDA news release (Free) http://response.jwatch.org/t?ctl=69280:5FF9B588B7CB016CC6303EA39D9CD708D2B71D9A95FA21D3&

FDA summary of test results thus far (Free) http://response.jwatch.org/t?ctl=69281:5FF9B588B7CB016CC6303EA39D9CD708D2B71D9A95FA21D3&

Background: Physician's First Watch coverage of OTC Zantac recall (Free) http://response.jwatch.org/t?ctl=69282:5FF9B588B7CB016CC6303EA39D9CD708D2B71D9A95FA21D3&

 

from Physician's First Watch 6.12.19:

FDA Asks Ranitidine and Nizatidine Makers to Expand NDMA Testing

By Amy Orciari Herman

Edited by

- Andre Sofair, MD, MPH, and
- William E. Chavey, MD, MS

The FDA is now asking manufacturers to test all lots of ranitidine (brand name, Zantac) and nizatidine (brand, Axid) for N-nitrosodimethylamine (NDMA) -- a probable human carcinogen -- before releasing them to the public.

If the NDMA level exceeds the acceptable daily intake limit (for ranitidine, 96 nanograms per day or 0.32 parts per million), the product should be held back, and the company should inform the FDA.

In its announcement, the agency notes that "there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine or nizatidine is also present." Accordingly, people who continue using these medications "should consider limiting their intake of nitrite-containing foods, e.g. processed meats and preservatives like sodium nitrite."

Link(s):

FDA announcement (Free) http://response.jwatch.org/t?ctl=6CBDF:5FF9B588B7CB016C6C287B31AF13161BD2B71D9A95FA21D3&

Background: Prior Physician's First Watch coverage of NDMA in ranitidine (Free) http://response.jwatch.org/t?ctl=6CBE0:5FF9B588B7CB016C6C287B31AF13161BD2B71D9A95FA21D3&

 

from Physician's First Watch 9.12.19:

FDA Investigating Whether Diabetes Drug Contains NDMA

By the Editors

The FDA is investigating whether the diabetes drug metformin contains N-nitrosodimethylamine (NDMA), a probable human carcinogen. Other drugs like ranitidine and some angiotensin II receptor blockers have been recalled over unacceptably high NDMA levels.

Metformin in other countries was found to have detectable levels of NDMA. The FDA says these amounts are within the range that naturally occurs in water and in some food. The agency is currently testing the domestic metformin supply, but it notes that there are currently no recalls.

Link(s):

FDA statement (Free) http://response.jwatch.org/t?ctl=6CE8E:5FF9B588B7CB016C00056D801F711D6CD2B71D9A95FA21D3&

Background: Physician's First Watch of ranitidine and NDMA (Free) http://response.jwatch.org/t?ctl=6CE8F:5FF9B588B7CB016C00056D801F711D6CD2B71D9A95FA21D3&

 

I've been switched from ranitidine to lansoprazole. I'm getting heartburn quite regularly now which was never a problem with ranitidine.

 

Nizatidine, Ranitidine Recalled Over Probable Carcinogen

By the Editors

Three lots of prescription nizatidine have been recalled after detection of trace amounts of N-nitrosodimethylamine (NDMA), a probable human carcinogen. These are the first nizatidine recalls since concerns over NDMA in antireflux drugs emerged in September 2019.

In related news, several lots of ranitidine are being recalled because of the same impurity, adding to a series of ranitidine recalls over NDMA.

The FDA recently asked manufacturers to test all lots of nizatidine and ranitidine for NDMA before putting them on shelves. Details of the latest recalls are available at the first link below.

Link(s):
FDA notices on ranitidine and nizatidine recalls (Free) http://response.jwatch.org/t?ctl=7061E:5FF9B588B7CB016C23B501396ADE06E4D2B71D9A95FA21D3&

Background: Physician's First Watch coverage of FDA's request to manufacturers (Free) http://response.jwatch.org/t?ctl=7061F:5FF9B588B7CB016C23B501396ADE06E4D2B71D9A95FA21D3&

Background: Full Physician's First Watch coverage of NDMA (Free) http://response.jwatch.org/t?ctl=70620:5FF9B588B7CB016C23B501396ADE06E4D2B71D9A95FA21D3&

 

Let your dr know. It didn’t work well for me either. Rabeprazole worked for a long time and now i am on esomeprazole.

 

One thing to keep in mind is the mechanism of action. Ranitidine is an H2 (histamine) blocker where as lansoprazole is a PPI (proton pump inhibitor). I get alot of benefit from blocking histamine due to food intolerance but reducing acid production is counter productive in my case.

 

FDA: NDMA in Metformin Is Low or Undetectable

By Amy Orciari Herman

Edited by
- David G. Fairchild, MD, MPH, and

- Lorenzo Di Francesco, MD, FACP, FHM

All metformin products tested by the FDA have either undetectable or low levels of N-nitrosodimethylamine (NDMA), the agency has announced. NDMA is a probable human carcinogen. High levels in other drugs, including some angiotensin II receptor blockers and ranitidine, have led to recalls.

The FDA posted the metformin test results on its website (see second link below). It said that when detectable, the NDMA levels in metformin are "similar to the levels you would expect to be exposed to if you ate foods like grilled or smoked meats." Accordingly, no recalls are recommended.

The agency says it will continue to monitor metformin for NDMA.

Link(s):
FDA news release (Free) http://response.jwatch.org/t?ctl=73334:5FF9B588B7CB016C4911C5864BA32D0BD2B71D9A95FA21D3&

Metformin test results (Free) http://response.jwatch.org/t?ctl=73335:5FF9B588B7CB016C4911C5864BA32D0BD2B71D9A95FA21D3&

Background: Physician's First Watch coverage of FDA investigating NDMA in metformin (Free) http://response.jwatch.org/t?ctl=73336:5FF9B588B7CB016C4911C5864BA32D0BD2B71D9A95FA21D3&

 

@Arnie Pye could you ask to be switched to Famotidine? It works like Ranitidine.

I was on ranitidine but taken off it within a few days. Then on double dose omeprazole for past few months and now consultant says I need to go back on a H2 blocker As my issue could be related to histamine and so far from what I’ve read, Famotidine seems to be safe and hasn’t been recalled.

 

I tried to get my ranitidine prescription changed for another drug of the same type, but was told that it wasn't possible. I can't remember the string of excuses the surgery came out with to be honest.

Although, having written that, I have just remembered I was told that I could be prescribed cimetidine which I had already read about and I discovered it has a very bad reputation for side effects (difficulty in urinating is apparently quite common).

 

I had been taking ranitidine for immune modulation purposes for the past 12 months. Unfortunately alternative H2 blockers aren't available in Australian pharmacies due to shortages (I was told that they would be back in stock at the end of January but have just been informed that they're still not in stock).

To make matters worse, my doctor is on leave due to ill health so I'm not sure what other options there are. I may end up trying an over the counter H1 blocker to see if it helps.

 

I didn't note down my starting date on lansoprazole but I think I'm now early in the third month of the switch from ranitidine to a PPI.

I've known for years that eating/drinking anything acidic increases the pain I live with substantially. I can't even take vitamin C supplements because they burn severely.

The ranitidine I was on obviously cut down on stomach acid output for which I was grateful because it cut pain. But I really, really wish I could allow my stomach acid to do its job of helping me to digest my food.

Since switching to lansoprazole I've found that my stomach acid production has been cut down much further than with the ranitidine - I think I must previously have had more being produced than I was aware of. Reducing my stomach acid with the PPI has actually helped reduce the pain in my colon quite substantially. But the cost of that reduced pain (in terms of quality of life) really makes me think it isn't worth it at all. I don't think I'm digesting much of my food at all.

Symptoms since switching from ranitidine to lansoprazole :

1) Regular bouts of heartburn. Previously I almost never got this.

2) Regular bouts of bloating. Previously rare.

3) General discomfort in my stomach.

4) General weakness and fatigue. I feel like a puppet that has had its strings cut.

5) The runs - a rare problem in the past.

6) Depression - previously a rare issue.

7) I want to sleep almost constantly.

8) Lack of motivation. This is a problem I have had practically my entire life, but it has got 50 times worse in recent weeks and I assume it is related to my lack of food digestion. Often I can barely be bothered to eat.

I've decided to see if I can find ranitidine available without prescription, at least in the short term. But the amount I need will cost me a fortune if I can find it at all. They come in boxes of 12 at half the dose my prescription was and I would need 4 tablets per day to match my previous prescription. The price of ranitidine has been rising quite dramatically for years, so having to buy boxes which will only last 3 days is incredibly annoying.