to feel really concerned by the Zantac withdrawal?

[Calledyoulastnightfromglasgow]

Rantidine is subject to a worldwide withdrawal due to possible contamination with a probably carcinogen, NDMA. The European regulator is still considering the issue but it seems likely it has gone on for years and across brands.

Firstly, can ANYTHING be trusted any more? It looks like raw materials were made in China and then taken to India and no one noticed the issues and it took an online pharmacy to bother to test the drug. How do these things happen? Why aren’t drugs tested properly? Why is it always maximum profit at any cost?

Secondly, I’m particularly sad and upset as one of my babies was in this drug for months due to awful silent reflux. I felt huge guilt at the time but felt overall the benefits outweighed the risks. And now desperately concerned that I won’t know if she received the contaminant.

It is all being downplayed and there is talk if “low Levels” but in reality they aren’t low at all.

Not all the formats are affected @Star39. The Zantac 75mg tablets aren’t. They are manufactured by a different company from the other ones. So it could be the ingredients or the manufacturing process. It could also be that it’s how ranitidine breaks down, just that the process used for the 75mg tablets is somehow better and prevents that. Or something else, they just don’t know yet. There are also other non-branded types of Ranitidine In various formats, not so much info on that out there yet.

It is hugely worrying but agree with Stuck - contact your pharmacy to see if the type you had for your baby Is implicated.

She had a generic solution and a Zantac solution / the Zantac is affected so I guess now it’s a waiting game to see the outcome.
The Zantac is manufactured by sanofi in the US.
Zantac in the UK is GSK. 2 different companies.
So surely this means the issue can’t be specific to one manufacturer ???
I contacted GSK and they told me this:

On September 2019 GSK has been notified by the Swiss regulatory authority (Swissmedic) that it has detected a genotoxic agent in our Zantac (ranitidine) injection solution. We have responded to the requests for information from Swissmedic and are actively working with them to address their concerns. We have also been notified by the Health Sciences Authority (HSA), the Singapore regulatory authority that it has found NDMA in ranitidine products (injection, tablets and syrup).

So this is in addition to the pharmacy in the US who detected an issue.

My feeling is it must be an issue with the API. Maybe the API is supplied to several manufacturers?

I knew a dr once who would always tick the box on the prescription (in Australia) no generic substitutions. I became friendly with him and things like this was the reason why. It is not the active ingredient that is dangerous it is the other things in the formulation, which are not the same with generics, yes the active ingredient is the same.

Star It’s possible several manufacturers/factories make the same “mistake” in processing, or that different manufacturers or different factories of the same manufacturer use different sources for ingredients.or something else. I don’t think we have enough information to go on to make a decision about that yet. That’s why it’s being investigated. It’s horrible that people have to wait to find out what the nature of the problem is, but that’s where we’re at.

My GP said something similar Amber- sometimes something non-active ingredients are an issue e.g. the dye in the shell coating. She feels drugs should be more standardized.

there are specialised companies who make the active ingredients and sell them to various medicine manufacturers who then make the different brands and formulations out of it.
if the issue is with the active ingredient a number of companies and medicines can be affected.

Yes , I think his is the case as otherwise surely it wouldn’t impact so many countries. Sandoz, apotex and sanofi in the US and then GSK here in the UK. I also read that some of the companies that produce The API also have the rights to produce their own generic version.
Surely the amount the babies are having it wouldn’t cause any serious harm? My baby was on 0.5ml
Another thing that concerns me is that ALL in date batches are being recalled which makes me think this issue is going back some time.

I'm worried about this after receiving conflicting advice. My DS is 9 months and his ranitidine is a generic liquid manufactured by Rosemont pharmaceuticals it is not the zantac brand. I'm really unsure whether that makes it ok or whether it will later come out that all ranitidine is contaminated.

Absolutely CuddlePounce, it is the additives, and generic companies generally use cheaper/not as carefully sourced ones that are the problem. If the actual drug Ranitidine was found to be carcinogenic ie would be a blanket recall. I guess you get what you pay for is sometimes true.

@HelenaDove you might want to be checked for a hiatus hernia and/or also a total overgrowth of hpylori bacteria.

Acid reflux can be caused by too much acid, but most commonly (and counterintuitively) by not enough stomach acid.

Chances are your gut biome is totally out of kilter if it isn't a hiatus hernia.

@LipstickTaserrr how long as your DS been in ranitidine? Has he also had Zantac as well? My daughter has had both (I checked with the pharmacy) I guess you get a mix of both depending on what they have in stock.
There is so much conflicting info at the moment, I totally agree. First this started in the states with their version of Zantac which is made by sanofi. Apotex and sandoz then did VOLUNTARY recalls and stores are not selling as a precaution. The FDA has not initiated a recall as such. Same as in here in the UK. The MHRA has not initiated a recall. GSK has done so voluntarily. No one knows what the problem is at the moment. I find it very hard to believe that all these different companies across the globe have had problems with manufacturing thus causing the NDMA. It’s seems none of these companies knew there was an issue with NDMA until they were told!
@Amber0685 you say the problem is with generic but it is the big brands where the NDMA has been found and the companies that supply the raw ingredient to the likes of GSK also have a licence to produce their own generic version of ranitidine.x

Andy Thank You. I complained for years but they just kept blaming it on my weight.

I remember getting up in the middle of the night in the late 90s to eat something because if if i did that seemed to stop it for a while (which didnt help my weight at the time either) i was put on Zantac shortly after.

Early last year my Virgin Care surgery stopped my Zantac prescription with no notice so i havent been on the 150mg ones for a while. I buy the 75 mg ones when i can.

@Star39 why has all ranitidine not been reacalled?

@Amber0685 good question. This makes this whole issue even more suspect. In all reports it states GSK has ‘voluntarily’ recalled their drugs. Same with the companies in the US. It’s all voluntary. The companies in the US stopped supply or earlier than GSK as well. It seems until they know for sure what the issue is, the MHRA and FDA are not enforcing a recall. However, the Irish HPRA has done a recall. Seems different by country. My friend is a nurse and she said they are still using ranitidine on the wards.
The MHRA has even said on its post that patients should not stop taking their medicine. So who knows what’s going on.

Not the FDA recalling:

Not all ranitidine medicines on the U.S. market have been recalled. Information about rantidine recalls is available on FDA’s ranitidine web page.

The announcements from companies that have recalled ranitidine are available on FDA’s drug recalls website. These announcements provide information to help consumers identify the recalled medicine (e.g., National Drug Code numbers, lot numbers, dosage).

Not FDA recalling, pharmacy own decision:
Some pharmacies have decided to remove ranitidine from their shelves out of an abundance of caution. This does not necessarily mean the medicines were recalled.

I think everyone needs to think more carefully when you are asked 'would you like the generic it is the same and costs less'?

@Amber0685 we weren’t even a choice! A friend from NCT told me about ranitidine- I had never heard of it, so I asked dr for it as had tried everything including baby gaviscon. I wish I had t now! Anyway, I took scripts to pharmacy and they fished out what they had. However, in this case it sounds like the generic would have been better than the branded. I pray to god the results are not as bad as the newspapers are making it out to be for the sake of all the babies that have had this medicine as well as adults x

I hope everything works out for you Star39 and think you baby wasn't on it a long time at all Xx

Thankyou @Amber0685 x

Thankyou @Amber0685 x

Update.......................................this reads like its all Zantac now.

www.devonlive.com/news/uk-world-news/popular-heartburn-medications-urgently-recalled-3466096

Yes. I have been following this very closely. I find it hard to believe all manufacturers get their API from the same supplier?? So is it something with the actual ranitidine molecule?