Phenindione shortage of supplies

Hi All

Has anyone got any further update on Phenindione? My mother suffers with AF and valve disease and has tried practically every anti-coagulant known to man....none of which agree with her.At last a Professor at Guys hospital has prescribed her Phenindione and now we cant get it anywhere! At least not the 50mg dosage she requires, and the rare 10mg that is available expires 19/07/2013.......I am at the end of my tether!!

I have spoken to Mercury Pharma this morning and they have confirmed all they have in stock is the 10mg due to expire 19/07/2013 and that more phenindione will be 'coming soon' after a manufacturing delay

Can anyone shed anymore light on this for me? Also - Mercury Pharma to me they were marketers - does anyone know the actual manufacturer?

Thanks in advance!

Hi Cressida

I contacted MHRA again yesterday. Their response below is not very helpful, except that it does give the current name of company. As you can tell from the exchanges we had late last year, this supply question is a constant worry and Goldshield/Mercury Pharmas responses are not reassuring for all of us who have been taking Phenindione for many months. If the pharmacy I use is able to get the 10mg I will accept this rather than resort to daily Heparin injections. The 25mg prescription I collected a month ago has an expiry date of 13 May 2013 and perhaps this isn't a problem but I do wonder about the efficacy of this drug now that I've been diagnosed for a second time with PE and brain clots.

best wishes

reddisa

'Thank you for your recent enquiry to the Medicines and Healthcare Products Regulatory Agency.

We understand that AMCo (previously known as Mercury Pharma and Goldshield) are currently out of stock of phenindione 25mg and 50mg presentations. We understand, however, that supplies of phenindione 10mg are still available from wholesalers so pharmacists should be able to obtain supplies as normal.

Please contact us again if you need further assistance with this, or any other queries. '

Wow , thanks so much, very nice to know that 10mg are in stock, my 25mg are also out of date, even though I am still taking them.

I will contact my pharmacy again to see whether they can get 10mg instead and will report back.

Hi Reddisa

Thanks so much for your reply. I am literally exhausting every avenue so any progress I make I will keep you informed. Wishing you well. Cressida

Hi Guys,

well my pharmacy put in an order for 10mg and they got sent a batch with expiry 19th july 2013, which theydelivered to me without even realising.

They rang the company who sent another batch with the same expiry date, the pharmacy have been and taken the 10mg off of me !!!!!

They have been told to ring back next week as to any leads on production of 10's and 25mg, and then they will come back to me.

If i hear anything I will post it on here.

I am however still taking my very last few of 25mg which had an expiry date of may, and my inr seems to be hanging in there !

Good morning all,

I am currently taking the last of the 25mg Phenindione with use by date of 13 May 2013. I collected 10mg with use by date of 19 July 2013 last week and immediately contacted the haematology consultant at Derriford Hospital. I am given to understand that he is a 'UK Expert in Anti-Coagulation'. His response is below:

'I am also very suprised that the pharmacists would not allow you to have the out of date phenindione as I discussed this at some length with the hospital pharamcist and we agreed that you should have some, particularly as it is a drug whose activity can be measured. So I have no idea who made that decision without consulting me again? I would use the remaining stock you have for now.'

You will have seen from my posting on 14 June the response I got from MHRA. I will contact them again on Monday and keep you posted.

best wishes

reddisa

Once again this year Pharma claim that there has been "a production problem".

I presume we are all aware that the medicine is actually manufactured in India ?

Last year they claimed - amongst other things - that the product they received had some discolouration.

Presumably that was excuse number two dreamt up by their highflying executives to attempt to cover up their inefficiencies ?

Does anyone have further info ?

Or any feedback on whether a date (however illusory) has been quoted for resumption of supplies ?

I wrote to MHRA on Monday:

'I write again regarding the withdrawal of supplies of Phenidione. Your response to my enquiries last October is copied below.

Once again, there are no supplies of 25mg and 50mg tablets. The GP amended my prescription to 10mg tablets last week but the pharmacy refused to dispense these because supplies received from wholesalers had the use-by date of 19 July 2013.

I would appreciate your advice as to when supplies will once again become available together with your comments on why this generic is apparently only available from Goldshield who, because of their apparent inability to produce a reliable and regular supply, are jeopardising the health and wellbeing of thousands of patients (including me) reliant on this anti-coagulant.'

and have not received a response so far. I will send another email and keep you posted.

best wishes

reddisa

Hi All

Just to update you. I have received no reply to the email sent to MHRA on 10 July. This morning I telephoned MHRA Customer Services and was told to forward the email I received from them in October 2012 which gave assurances about future supplies of Phenindione. I have just done this, copy below. Perhaps, if you are still unable to obtain supplies you might consider telephoning MHRA to add some weight: 020 3080 6000.

best wishes

reddisa

'In relation to your recent enquiries around Phenindione, we would like to confirm that Phenindione 25mg tablets are now available from Goldshield, so you should be able to obtain supply and resume on this medicine - please do let us know if you still have any issues obtaining this medicine.

We would like to assure you that both the MHRA and the Department of Health are working closely with the company to help ensure that continuity of supply of this important medicine is maintained.

Kind Regards,

Ben,

Customer Services

External Relations

Medicines and Healthcare products Regulatory Agency

Tel: 020 3080 6000'

reddisa

I have once again been intouch with all the "authorities" and this morning Goldshield sent a response advising that supplies of the 25mg tablet SHOULD be available before the middle of next month.

Of course we all know that this is merely their fallback position - so fingers crossed.

In the meantime you have probably received an email from the dreaded MHRA. saying much the same ?

I find this mildly amusing since they have merely reacted to my geeing-up of yesterday, but are presenting it as if they have leapt dynamically out of the slips ! Ah, well.

By the way I found it impossible to log on to this forum under my previous guise, so I WAS a88, but am now AL37

Hi AL37

Just received the MHRA response below - they seem to have reduced the time it will take for supplies! I'll forward this to the GP's pharmacy, put in a repeat prescription and see what happens.

best wishes

reddisa

'Thank you for your recent enquiry to the Medicines and Healthcare Products Regulatory Agency.

I can confirm that phenindione (all presentations) are currently out of stock as a result of manufacturing difficulties, however, the company have confirmed that stock of the 25mg strength is expected to become available again next week.

I hope you find this information useful.

Kind Regards,

Ronke

Customer Services

External Relations

Medicines and Healthcare Products Regulatory Agency

Tel: 020 3080 6000 '

NO - reddisa, the MHRA have merely repeated what I received back from Goldshield in their latest guise.

I stated "mid-August" on this forum because I have yet to give any credibility to what I am being told. Call me a cynic if you like but just because they have now changed their name once again leaves them with a lot of ground to make up before I for one, will do anything more than keep my fingers crossed and hope for the best.

As an aside, when did any conglomerate really act in the best interests of their "Customer" ? Profit is the name of the game here.

Like me, you have now probably received a message from the Group seeking to improve theri customer relations. I for one do not trust their motives - it could be the first shot in their attempts to discontinue supplies altogether. Where have we all heard the statement before ? "Trust me I'm a Doctor" - don't make me laugh ! Please don't be taken in. Exercise caution !!!!! I do not intend to reply, but I'm sure others more naive will do so.

Good afternoon everyone (I had a school flashback then!)

Just to let you know that my pharmacy has delivered 25mg of phenindione today, they are in complete new packaging but still have to be used by 24th October 2013 which doesn't seem very long for a newly manufactured product.

Nic

Nic,

thanks for this.

I had to use Fragmin yesterday and was more than a little concerned that I'd be injecting for weeks to come! Pharmacy delivered Phenindione this afternoon. Yes, new packaging and same use by date - I've queried this with Haematology Consultant who assures me that the date is not relevant since users are monitored for INR/efficacy and the supply I've just finished had a use by date of 19 July 2013.

Don't you just hate being in this position?! I'm just relieved not to have to inject Fragmin tonight and i hope for all our sakes that supplies are back to normal now.

be well

Hi everyone

Once again, and after only 3 months, Phenindione is not available. Anyone else been told this by local pharmacy? I'll be contacting MHRA on Monday and will keep you posted.

be well