Ranitidine syrup recall

[DeeDee3210]

Please help. I am devastated and breaking down. In June 2019 my son was 6 weeks old weighing only 3kg. Without any investigation he was given ranitidine which we gave to him trusting our faith in the doctor. Now I have recently discovered this stock has been recalled due to dangerous contamination. My precious baby boy took it 3 times a day for 7 days. I am in agony. I keep crying everytime I look at my baby's precious face and thought of this poison being inside him. I am terrified of the future which has increased his risk. Has anyone else given their baby recently this medication? How are you coping if so? Or if there is anyone out there who can help as I feel broken , terrified , devastated and angry. I am so scared for my baby boy I love him so much he is my life.

I am just crying constantly knowing I have given my innocent baby this. He is just an innocent baby and this may have affected his future. How can I continue to live normally from now on knowing this? I can't even hold him without crying , I love him so so much.

Is it not just a theoretical risk at the moment? He didnt even take it long term. I think you should calm down a bit and enjoy your time with him.

I would make an appointment with your GP to discuss this. You need to talk through your concerns and hopefully be reassured by what the doctor will be able to tell you.

1 week of the drug at such a low dose doesn’t seem so awful when you consider that some people may have been taking the drug for much longer periods.

I understand you having an initial feeling of horror about it but you need to find a way of not letting this make you too anxious.

I understand, it's hard when we only want to protect our babies. But overfocusing on this is not going to help you or him. Focus on the things you can control - like having a lovely day with him to create a reassuring, calm home environment. An upset or anxious mum does not a happy childhood make, you have to face things confidently and authoritatively to give him a secure base. If you are still worried, make a gp appointment and be open to accepting the facts in perspective or thinking about whether you need any help with how upset it has made you. (Like my GP told me that my medication raised my risk for X by '1 factor' whereas being overweight raised it by '12 factors', for example).

Hi.

I have also given my baby ranitidine but at the highest dose for 4 months so he has had a lot of it. I am obviously concerned about what this means but tell myself I acted on medical advice at the time. We have no findings yet and initial tests said the impurity whilst was at a higher level, was not at extremely dangerous levels but of course that may change as the investigation reveals its findings.

Easy to say but I try not fixate on this and ruin the time I have with my baby. The carcinogens are also unfortunately found in processed food and surrounding pollution so we can never truly make anything safe for our children.

Do you know which batches were contaminated ie whether you gave a contaminated batch? I no longer have the bottle so can't tell which batch I gave out.

I hope you are OK and that we get a conclusive answer soon.

Yes @evaharknessrose makes an excellent point about risk "factors". Everything is all relative so I imagine smoking and drinking whilst pregnant or smoking around the baby would do more harm than the ranitidine given to the baby.

Thank you everyone for your replies. I too no longer have the bottle, but I rang pharmacy and they said it was the one they recalled. And suspect contamination. Did you give it to your baby recently,? How old was baby at the time? I understand that putting into perspective and not to be so anxious but I am finding it so difficult to control my feelings. I am seeing the GP today but with no conclusive findings, I fear I will still feel the same. I am struggling to cope with this. My instincts at the time were not give it for other reasons, then I saw a nurse few days later who said give it. I am kicking myself, cannot forgive myself, and I am praying my baby boy is and will be ok. It's so scary. I'm so sorry that you are also in this position.

Take a deep breath yes NDMA probable carcinogen but it is looking likely that
(a) the risks were exaggerated initially by the temperatures used and it’s low
(b) you would need to have taken it a high dose for a long time
(C) they are still recommending there are cases it should be used

It’s like the ham/bacon one the amount you would need to eat would be huge

I think you need to discuss your anxiety

Thank you for your reply. I will be talking to GP today about everything. But I am not sure it will change how I feel due to fact my baby had this medication. My mind is just on this 24/7. It's not going away. I hate myself for giving it to my precious baby.

www.medicinesforchildren.org.uk/news/recall-ranitidine

Says continue to give it and risks are low

Especially as he was so tiny. So in proportion to his body size, he has a lot

Pointless to hate yourself. What's done is done and unlikely to be any harm done at all

Had*

Just to pick up on a point but every ranitidine product was recalled not just certain batches so it may be unlikely it was a contaminated batch he had. Please do t worry too much like other people have said eating meat is carcinogenic so many things are. X

But his dosage would have been adjusted accordingly

The rantidine isn’t the issue it’s how your anxiety is catastrophising it that you need to discuss

Thank you for your reply. I just can't get it out if my head that if it was the manufacturing process that caused this, then it would affect all batches anyway. I'm really struggling to deal with the unknown of it. I am wondering why GSK haven't posted results yet , with such an important matter, you would think the initial tests would be reported. Then I think they haven't done it because the results are so bad and now continuing to test further and how it got contaminated. Then deciding a plan on how to handle the bad news. This is what is worrying me and going on in my head. I am really struggling to move past this. I look at my baby , even now, and I hate myself. He is so precious and so wonderful. And I'm devastated that this is inside him. Thank you so much for everyone's replies. I really appreciate it

Yes, you need to discuss your anxiety levels rather than the ranitidine issue I think.

I would be really honest with the gp about how this has made you feel. I do understand it's horrible for something like this to happen (my DS2 also had ranitidine for a few weeks a couple of months ago) but I do think your reaction is quite disproportionate and there might be some post natal anxiety maybe?

Have you felt more anxious generally during pregnancy or since baby has been born? I was very anxious during pregnancy and post natally particularly with DS2. The focus for my anxiety was that DS would contract herpes. I spent hours researching and obsessively checked DS for symptoms. DS was fine but I was convinced it was only a matter of time. Looking back I can see that my thoughts weren't rational but at the time they were very real and all consuming.

I hope the GP can help, congratulations on your baby.

I think the reason GSK haven't reported is because they want to make sure of the results before publishing. It could be the opposite and they are struggling to find any contamination but cannot report that until they are absolutely certain due to the risk of being sued. As of yet so little is known about the level of contamination, the affected batches and the risks that I honestly would try and move on. The reason medication has batch numbers on is because the ingredients of the batches vary, there can be small variations in manufacturing processes (eg temperature on site) and different manufacturing plants are used. I know it is worrying but the risk to your little one is so small after just 21 doses that you will never know if it has caused a problem. Living next to a busy road with air pollution, eating processed meats and genetics can all increase the risk of cancer and if your little one is ever unfortunate enough to be diagnosed, there is absolutely no way of determining whether ranitidine was the cause

I would calm down. The risk is theoretical at this time, often they recall entire batches if one sample has tested positive for tiny amounts of contaminates. If he’s fit and well I doubt the GP would even see him to be honest.

Ranitidine is dosed proportionally on body weight so there is no chance of him getting a massive dose anyway.

I think you need to see the GP yourself, this level of anxiety in the face of a very tiny risk is not healthy for you or your baby.

I would calm down. Ranitidine is still being prescribed so cant be that bad. A member of my family is on it.

Thank you for the reply. I have always worried about my baby boy, but because this has actually happened ie I gave my baby this, I am feeling like this. I know everyone keeps saying it is low risk, but the fact that this risk could have and nearly was avoided, is breaking me. And when you read even such small amount can pose a danger, I feel devastated. Thank you for your replies. I am seeing the GP today and discussing everything including how I am feeling. I just know, my feeling will not change as my baby (and other babies in same position) should never have been put in this situation. That is what is breaking me.

The standard of manufacture for medication in the EU is one of the highest in the world. When they recall items it’s generally due to issues such as tiny amounts of particles unlikely to cause harm but fall slightly outside the standards allowed by the EU.

Sometimes a recall is unavoidable as they need to legally do it and cannot take the (tiny) risk. You are more much likely to become ill from contaminated food products than anything else.

If there was a serious risk to life the advice would have been to seek urgent medical attention. This has never in my 10+ years of pharmacy actually happened.

I haven't been told it's dangerous! I was giving it to my son over 6 months! 😧 When did that happen? The recall? Sorry I don't wanna sound rude just shocked because yesterday he just had one dosage 😞

@brig93 There is a recall on certain brands and batch numbers, your local pharmacy will have an up to date list. It’s not dangerous, mostly voluntary recall.

Thank you, just called my health visitor team they have advised me to book an appointment with GP.. I will be having a call back from the GP within an hour let's see what is gonna be the result or any steps.. I'm completely shocked. I was advising this medication over the months to mums as it was amazing for my DS and now I'm a bit afraid as health visitor team had no idea why it was recalled and what are the effects of usage of this medication.. anyone had already some answers regards of this?