§ Further verbal update from B-M S by 'phone 10 Jan 2008:-

In a telephone call I received from B-M S this morning, I was told that they have now completed their initial studies on temperature degradation of the new formulation of 'Florinef'. Whilst the report on this has not yet received official approval from the appropriate UK government body and thus the following information will not be added to the package inserts or advertising literature until this official approval is granted, because of the concerns raised on the storage aspects of new Florinef by ADNetwork and others that they decided to actively contact these interested parties by 'phone to advise them of their laboratory findings, which they are happy for ADNetwork to publish on this web site.

Following intensive studies, B-M S have established that the new formulation of 'Florinef' do not significantly degrade if left out of the recommended refigerated temperature of 2-8 degrees Celcius for up to one month. This is however dependent on the tablets being stored at a room temperature NOT EXCEEDING 25Deg Celcius for this maximum period of one month.
If either of the constraints of temperature or length of time are exceeded then the tablets MUST NOT be used and should be discarded immediately.

I have also discussed the problems patients have raised relating to the new formulation of Florinef with a dispensing pharmacist who has also contacted B-M S on the matter.

My contact was told that the question of how much degradation occurs over what timescale is actively being investigated at the moment. It was reported that preliminary investigations suggest that degradation over time may not be as severe as was originally suspected. Results appear to show that degradation of these tablets at a continual temperature of 25º celcius over a period of 6 months is less than 1%.

It was suggested to my contact that long distance (& thus time) travel by air, etc., should result in the tablets remaining active provided the temperature does not exceed 25ºcelcius or exposed to freezing temperatures (thus they MUST NOT under ANY circumstances be placed in the luggage hold of a plane for example), and that the tablets are returned to a fridge at between 2-8º celcius as soon as possible on arrival at your destination.

It must be remembered that these are just preliminary results and as such are merely an unofficial guide.
The new formulation Florinef tablets MUST be refridgerated under the conditions stipulated by the manufacturer in their instructions detailed above and in their package insert.

The manufacturers have told ADNetwork they will provide us with any further updates as soon as available, at which time we will be pleased to release them on this web site.

Until that happens, we cannot stress enough that the advertised new storage conditions provided by Bristol-Myers Squibb MUST be adhered to.

We would like to express our thanks to Bristol-Myers Squibb for the information and assistance they have provided to ADNetwork on behalf of patients with Addison's disease, on the new formulation of Florinef.