Congenital Adrenal Hyperplasia

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re: re: re: florinef changes
Feb. 23rd, 2008   8:21pm

Hi Safina

Sorry, I posted an update in the support group latest newsletter and also on the UK website, but unfortunately forgot to post the latest information here too!  Here goes:

I have recently been told from Bristol-Myers Squibbs that the latest results from a stability study on the new florinef tablets conducted in Australia showed there was no evidence of any deterioration in Florinef tablets when they were kept out of the fridge for up to one month.

The study emulated 'real life' with 'random exposure' and 'no significant changes' were detected in the one month study, regardless of the environment they were kept in (I assume this means tablets were exposed to a variety of temperatures). They are however still recommending that tablets are kept in the fridge but that patients travelling shouldn't worry about periods of unrefrigeration, as long as this doesn't 'cumulatively exceed a total period of over one month' but patients should refrigerate wherever possible.

I did reiterate that patients were far from happy with the restrictions caused by the new tablet and got the usual spiel about a new production site, the necessity to increase the shelf life due to previous shortages, which improved efficiency etc (?) Also the change in colour is due to new government guidelines suggesting that colouring should not be used in any tablets, unless strictly necessary. Shame really as we often call them the 'pink tablets' and the 'white ones' - now they all look very similar, which I hope does not lead to mistakes being made!

We do have a petition on the UK website www.livingwithcah.com which we will be sending to the manufacturers in due course.  Please sign this if you agree that the new tablet is life restricting for patients!

Sue




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