Integrity of prednisone tablets

[Alebeau]

Has anyone ever had an issue with the strength of 5 mg tablets of prednisone not working as they should? That is to say that after taking them you experienced an unusual increase in pain levels.

Thanks

[SheffieldJane]

It is something that has crossed my mind and occasionally concerned me over the years. For instance Use by dates and moving on to Gastric Coated Prednisalone. It would be so hard to prove as our conditions can be up and down too. I think if I felt that I’d got a bad batch, I would try to persuade the pharmacy to replace them. There would be so many checks and consequences for the pharmacy, I feel that it would be very unlikely. Keep an eye on the use by dates though - that has happened to me, once in 5 years.

[Coffeebeans in reply to SheffieldJane]

I took a weeks worth of out of dates ones 🙄. Disposed of once I noticed- It's not worth introducing another variable is it 😧

[Kendrew]

Hi Alebeau. I know I'm not going to be able to give you a definitive answer here, but I remember....and it's not that long ago.....PMRPro responding to a question, and I'm pretty sure she intimated that there are sometimes situationss where different batches of pred can occasionally react slightly differently to the norm. (ie. slower or faster absorbency and therefore more or less effectiveness) Unfortunately, I can't remember what the post was about so can't locate it, but I remember thinking that I'd never realised there could be discrepancies between two different boxes or two different batches of pred. Sorry that's a bit vague.

[MrsNails]

Yes, going back a while ago l thought l had a ‘dodgy’ batch as l very suddenly started to feel as if l hadn’t taken my Pred - to be honest l ditched them & used a different packet/batch.

I also had a packet once that crumbled as l popped them out of the packet, they were 1mg so l disposed of them back to the Chemist.

If you suspect that, put them to one side & used a different batch. You can’t ‘prove’ anything either way & as long as you have spare use them instead.

MrsN

[SnazzyD]

I had Pred twice that clearly didn’t work as well and I was able to test it because the change happened within a day. It was due to a different brand one time and an out of date box the other. Others have noted similar on here but it can’t be proved with anyone.

[Koalajane in reply to SnazzyD]

I was given a different brand once and I am convinced they were not as good as my usual ones so have ditched them

[Alebeau in reply to Koalajane]

Thanks for letting us know.

Good luck in the future.

🙂

[Heron82]

Hi in theory no one should have a dodgy batch of tablets as each batch has to be tested and the results reviewed and quality control released before it can be sent to the pharmacies. Each batch is manufactured to high and consistent standards. If anything goes awry, ie defective packaging or other, then there are processes in place for recalls co-ordinated by the manufacturer, pharmacies and regulatory agencies. If you think you have a dodgy batch you should report it to your pharmacist.It could be that you need a higher dose if you are getting pain rather than the pred being at fault. The absorption of GR vs film coated pred isn't that different so this should only have a minor effect in some patients. Again something to speak with your doctor or pharmacist about.

Hope this helps

Best wishes

Heron

[PMRpro Ambassador in reply to Heron82]

When it happened to me the same total dose of a different dose pill worked perfectly,

[PMRpro Ambassador]

I had a problem with a batch of enteric coated prednisolone - I had been fine on 10mg for ages, the tablets came in blister packs so there was a date on them as well as the other details. Then suddenly the refill was in a bottle with no indication of anything. We spent a lot of the year here then and I didn't discover the problem for several weeks by which time I was back here. I suddenly had a flare while taking 2x5mg. Something made me try 4x 2.5mg and that worked fine. The pharmacist denied there was anything wrong and no-one else had complained he said - not that many people would have been on them from such a small pharmacy. That was when I was switched to methyl prednisolone which is what is usually used here - that was awful too in not being as effective and causing awful adverse effects.

If someone says this sort of thing I always ask whether they have just started a new batch of tablets - and suggest they look at the manufacturer. Different manufacturers use different fillers to make up the tablets - and some people are very sensitive.

[MrsNails in reply to PMRpro]

I know it’s a different story but Professionals don’t always believe Patients, many years ago when Martin was little & GP’s held their own budget’s some bright spark decided Nationally (to save money) that Ventolin Inhalers could be replaced by Generic Salbutamol.......

And, people said their Inhalers weren’t as effective & they were using more, then there were cases of very serious asthmatics collapsing who’d always been responsive in the past!

So they were examined & lo n behold the molecular actuate in the Generic Salbutamol was not the same as Ventolin & ALL those Patients were right! My Mum being one of them, l was still using a Nebuliser for Martin so hadn’t really experienced it first hand but the Inhalers he had were all changed.....

I just wish they would listen to us!

[PMRpro Ambassador in reply to MrsNails]

Yes - I remember that. It cost them a fortune in the end if I remember rightly. Just to save a few pence per person they put people's lives at risk. I think it was after that that they began to realise that generics aren't always the same. I'm supposed to get the "original" of the antiarrythmic I use but it means I'm supposed to pay the difference (the generic is covered) and it is actually quite a bit per month. Anyway - at my pacemaker check this week she told me that last year when I was on the original I had 4% a/f and this year where I admitted to having switched to more the generic it was 8%. Though to be honest, I had a dreadful few months back in the summer until I decided to try stopping G&T and I blame that! Far less trouble now

[MrsNails in reply to PMRpro]

Goes to show though.....

[Alebeau in reply to PMRpro]

Thanks, I am much better now on a different batch of the 5 mg tabs.The pharmacist is going to advise the drug company of this issue.

Scary - I will now be super vigilant of new pain that is out of the ordinary- this wasn't just minor pain but more a 9 out of 10 level that affected my sleep.

I appreciate you sharing your similar story, thanks.

[Alebeau]

Thank you all for your responses.

In desperation I went to the pharmacy and got a new batch of 5 mg tabs and thank God they are working as before, had a good night's sleep. I will let my rheumatologist know about this horrible experience- it was like turning back the clock to the very beginning of my PMR journey.

Beware if this happens to you.

[PMRpro Ambassador in reply to Alebeau]

Have you returned the dodgy ones? It is always possible there is a faulty batch or that some counterfeits have got into the supply chain

[Alebeau in reply to PMRpro]

The pharmacist gave them back to me. I will ask my rheumatologist on Jan 21 about possibly having them analyzed as they clearly did not work for me 3 days in a row.I am hoping this never happens again as I feel drained after 3 days of pain, I think it will take me a week or so to get back my momentum.

[PMRpro Ambassador in reply to Alebeau]

They can't use them (luckily) once they have left the premises. But I would be asking for some investigation. If they are dodgy they could have been used for someone with GCA - and they lost vision as a result.

[skipspmr]

No. I've used 5 mg and other mg as old as 3 years without ever any problems.

[DorsetLady PMRGCAuk volunteer in reply to skipspmr]

I see you asked a similar question 10months ago - but I also see that you have been having issues with reducing since - so if you’re taking out of date tablets maybe there’s your answer....whether you like it or not, they may not be as effective as those in date.

..so maybe your statement -

“No. I've used 5 mg and other mg as old as 3 years without ever any problems.”...is not strictly true.

[skipspmr in reply to DorsetLady]

Well, since then I've done some extensive experimenting and it appears to me that there is no deterioration over time. However, if supply is no problem, and being so inexpensive, why not take the most current. I'm DSNS tapering currently at 2 mg for 4 weeks, then 2/1.5.

[Fran_Benson Partner in reply to skipspmr]

Hi skipspmr, we wouldn't recommend using medicines after their expiry date: nhs.uk/common-health-questi....

Fran

[skipspmr in reply to Fran_Benson]

Of course not. No professional or anyone in a responsible position is going to recommend using past the expiry date, and that is why we will never know for sure whether or not if it is safe to do so. It is in the best interest of the manufacturer to put a super-safe expiry date on all meds and in the best interests of medical providers and pharmacists to recommend accordingly, so we will never know. The end user is never going to get any useful information regarding this from anyone but anecdotal evidence from other end users. Anyone in the chain above an end user will of course protect themselves with a safe stock answer. The foregoing is irrefutable common sense logic.

[Alebeau in reply to skipspmr]

Thanks, it was fine for me for over 2 years till this happened.

[Zebedee44]

I’m really intrigued by this posting because lately I have also wondered if my 5mg tablets have any of the drug in them and sometimes whether I have forgotten to take them. As a result I have returned to a daily dose of 10mg which I’m not altogether happy about, having been managing on 7-8mg for over two years.

The manufacturer of my current in-date pack is ACCORD. Is anyone else using this supplier?

[PMRpro Ambassador in reply to Zebedee44]

Ask the pharmacist if you can have a pack of a different brand to test ...

[Koalajane in reply to Zebedee44]

I use Accord and have never had a problem with them.The ones I I had a problem with were made by Genesis

[PMRnewbie2017]

Have a look at Gov.UK Yellow Card Scheme. This is the official mechanism for reporting problems to the MHRA. Briefly addressing your other question:

It is not uncommon for patients to get different therapeutic responses from different brands of medicine. Clinicians deny it happens as do manufacturers, but it does.

Expiry dates have a large tolerance. Blister packaging reduces problems caused by air (oxidation) and moisture (hydrolysis). Storing medicines above 25DegC can cause deterioration. Daylight also. A product which has passed its expiry date shouldn't be used but would probably be ok for at least six months. Years ago we used to send expired medicines to Third World nations to help. This no longer happens due to ethical issues.

Unfortunately there is no mechanism that I'm aware of for dispensed medicines to be recalled if a problem is discovered.

The MHRA are very strict and thorough. They check manufacturers production and quality control records annually or every two years. They have the power to suspend production and cancel the Marketing Authorisation if compliance is lacking. The chances of a batch of tablets containing no active principle are very remote.