Phenindione shortage of supplies

Hi I am also now on Fragmin as a temporary measure. I have been calling, emailing and writing to

Mercury Pharma since May, when I first discovered that there was yet another shortage, (Same thing

happened last year). Since then I have been on to them on a weekly basis, and have always had the

same answer, "Phenindione will be available at the end of the month". I have got my MP involved and

have even had a letter from the Minister of Health. I have also tried getting the Medicines and Healthcare products Regulatory Agency (MHRA), World Health Organisation (WHO), National Institute for Clinical

Excellence (NICE), Association of the British Pharmaceutical Industry (ABPI) and the press involved, all

with either no or limited success.

On a slightly brighter note, I heard from Mercury Pharma this week that they are awaiting approval from

MHRA to release some 25mg Phenindione tablets to Market, a process which could take 2 - 6 Weeks.

Mercury Pharma have given an estimate of mid month (October 2012)!

Mercury Pharma have a monopoly on this drug, where else could manufacturing problems take over

6 months to resolve? But there seems to be no appetite to take this drug off licence.

I have an allergy to Warfarin, but my GPand consultant are proposing to try and get me desensitised to

Warfarin, so we will see what results that brings.

I agree as many people as possible should CALL, EMAIL AND WRITE to Mercury Pharma and put

pressure on them to get production back as soon as possible. I would also urge individuals to involve

their MP's the more political pressure the better.

Hi there, Really feel for you. I've got 4 people ringing Mercury Pharma on a regular basis and we've been getting the same responses. They have not responded to any of my emails. Yesterday, my GP said she would again be asking the surgery pharmacist to follow up all the enquiries made over a period of 6 months.

Meanwhile, I got admitted to the local hospital 3 weeks ago with chest pains and shortness of breath after being on Fragmin for nearly three months. Bruising and abdominal pain worsened and I couldn't face another injection. The consultant was aware that, like you, I have an allergy to Warfarin but put me on Acenocoumarol (another form of Warfarin). I now have blurred vision, swollen neck glands and bleeding nasal passages.

I am beginning to think that the reason patients on Phenindione are not getting the support we need is cost. Warfarin is cheap by comparison to Phenindione. I keep getting told that 'the majority of patients do well on Warfarin' as if those patients have no side effects when in actual fact they choose not to complain to their doctors , never get their drugs reviewed and take a variety of other drugs to deal with side effects.

I will write to Mercury Pharma again and forward a copy to my MP, Dr Sarah Wollaston, asking for her support.

Wish you well and hope this issue will be resolved soon for all of us.

Hi, Think you have it worse than me, your situation sounds awful! I do hope they sort things out for you soon. Out of interest think we are neighbours, my MP is Adrian Saunders!

I agree the cost of Phenindione is high and recently I found some for £14.52 per 10mg tablet, but they wold only supply 28 tablets which when I'm on 50mg per day is absoultely useless.

I've been told some of the new anticoagulants on the market are pretty good, but they are not licenced for use with my condition and are unlikely to become licenced either!

I wrote to the MD of Mercury Paharma but have never had a reply, going to try the board next, but do not hold out much hope. Tempted to travel down to Croydon and park myself on the doorstep of their HQ!

Fingers crossed for a speedy resolution to this supply issue.

I too have been chasing for phenindione. warfarin makes me really ill, so I am back on clexane injections.

My anti-coag clinic have discharged me until phenindione comes back into stock.

My belly is really sore and bruised, I can cope with that but the injections don't work as well as the tablets.

I have Hughes Syndrome and Lupus and I am loathe to try yet another form of medication when I am trying new ones for my Lupus too.

I just can't uunderstand what the hold up is, no-one can give me a reason. Are they being sold abroad for more money?

I really feel for you, your condition sounds grim. If we can believed Mercury Pharma, we should have Phenindione back this week!

I cannot believe they have taken 6 months to rectify a "manufacturing problem!" I asked my MP to look into it, but he got the same response.

Hi PhilH

I haven't heard from any of my contacts during the past week and the longer it takes to get Phenindione back the more worrying for us all. I have Myeloproliferative Neoplasm and recurring Pulmonary Embolism. Acenocoumarol is the alternative I accepted because I was so desperate to stop the daily Fragmin injections, but I realise now that the side-effects are even worse than ones experienced on Warfarin.

Rivaroxaban is one of the new anti-coagulants being pushed but, like NicE, I'm loathe to add another new drug when there is nothing in the trial papers I've read to reassure as regards inter-action with the medication I'm already taking or the effect it might have on the primary condition.

Hope Mercury Pharma really are releasing supplies this week and that I gets to our neck of the woods sooner rather than later!

Best wishes

I'm planning to start an hour mail to Mercury Pharma tomorrow asking for an update and I'm going to copy MHRA. I also intend to ask an FOI question of MHRA asking them what tests they have to do and if they are testing Phenindione at the moment and when Phen... I'll be released to market. I'll let you know he outcome on this site

Good luck with this. Anything I can do to help? Look forward to hearing from you

Heard from Mercury Pharma, They say that 25mg Phenindione will be released next week! I also submitted 3 FOI requests to MHRA about why no Phenindione and what they have done to secure future supplies.

Hi Phil,

that is fantastic news, unfortunately I won't be holding my breath. call me a pessimist but they haven't fulfilled their promises before.

Anyway lets watch this space I shall be contacting my local pharmacist next week.

fingers crossed.

Hi NicE,

I agree I am not holding my breath either! Icannot believe that they have been unable to resolve the manufacturing issues within 6 months, I think there is more to it than they or MHRA are saying.

I have just heard that I'm going in to hospital on Thursday so they can try me out on Warfarin and see if I really am allergic. Fingers crossed.

Well, i just contacted my pharmacy - they have no news what so ever of phenindione coming back into stock.

If anyone does manages to get hold of some next week - please shout about it!!!!

Hi Nic, will certainly shout if I get any news. Hope Phil is ok with the Warfarin tests. My experience with susttute Acenocoumarol is far from pleasant and today my INR has inexplicably dropped again to 1.7 so I'm getting pretty desperate.

Wish you well

Hi,

News for you all, Firstly I have copied an email I received from Mercury Pharma today. Good luck getting hold of them.

Secondly, So far so good for me on Warfarin, no anaphylactic shock and just the weekend to go on a low dosage to see if there is a cumulative effect.

----------------------------------------------------------------------------------------------------------------------------------------------

We would like to inform you that Phenindione 25mg Tablets (PL 10972/0038 ) are now available and can be procured from your local pharmacy on a prescription from your Physician.

If you have any concerns regarding the product, please address these to Mercury Pharma Medical Information on the contact details mentioned below:

Tel No.: 08700 70 3033

Email: medicalinformation@mercurypharma.com

Prescribing decisions about Phenindione will be at the discretion of your doctor only. Please consult your doctor for any concerns about your condition or dosage.

Regards

Medical Information Manager

Mercury Pharma Ltd.

No.1 Croydon

12-16 Addiscombe Road

Surrey CR0 0XT

Email: medicalinformation@mercurypharma.com

Tel: +44 (0)8700 70 30 33

Fax: +44 (0)20 8686 0807

Web: www.mercurypharma.com

Information provided by Mercury Pharma Medical Information should be viewed at all times alongside the Summary of Product Characteristics. It should not constitute formal clinical advice. The prescribing decisions and clinical management remains at the discretion of the responsible physician. Please feel free to contact us if you require further information.

Try copying even a portion of the email I got from Mercury Pharma today and it goes for moderation.

25mg tablets of Phenindione are available!!!! (PL10972/0038) good luck all of you.

It would appear I'm not allergic to Warfarin, the anaphylactic shock test was fine, just doing the cumulative test. decision on Monday.