| Posted by Shirley-Arkansas-USA ® , Jun 22,2001,22:11 |
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I sent the second email off to Allergan yesterday and this morning I received a very nice phone call from one of their representatives. The gist of the conversation was that they are aware of the fact that some doctors are freezing reconstituted Botox and saving it for later use. They disagree with this practice and say that their guidelines should be followed. She had gotten my first email and had talked to several people about it and asked questions and they had been discussing the issue when she got my second email and decided that it would just be best to call me rather that try to explain in an email. (No paper trail, either, but I understand)We talked about a number of things but this is some of what I got out of the conversation.
The practice of freezing botox after reconstitution is primarily being done by doctors that use it for their cosmetic patients. They apparently have been able to get away with doing this as the botox has not totally lost its effectiveness. We discussed the fact that smoothing out a wrinkle or two is quite different and requires less of the toxin than relaxing a muscle for the various forms of dystonia.
The toxin becomes quite unstable when it is frozen and its molecular structure changes and is broken down. She mentioned that going from a frozen state in a syringe to thawing in 5 - 10 minutes would also effect the toxin in a negative way. It would be much better (if one was going to do it) to thaw the toxin slowly in the refrigerator.
No studies are planned for this. Animal testing would need to be done and they already know that the protein in the toxin breaks down when it is frozen. They do not know how freezing effects the molecular structure, they just know that it does, thus the reason for not doing it. Even keeping it refrigerated, right above freezing, can not be done for an extended period of time as there is no preservative in the botox and certain bugs thrive in refrigerated temperatures. They know that things remain fairly stable for at least four hours. She added that it probably would be safe for up to 24 hours if not frozen but it would be deteriorating during this time and starting to grow things.
She also commented on the plastic syringe and the fact that if it was frozen in the syringe that the protein might adhere or leech to the wall of the syringe, also changing its effectiveness.
It was a very interesting conversation and she was very forthcoming with information. I appreciated her honesty and candor with the situation.
So folks, if you want a wrinkle removed, go for it, but don't even count on it doing a good job for that. If you have Blepharospasm or some other form of dystonia and someone hands you a syringe of frozen botox say "no thank you" and make sure that you see a new vial of botox before it is injected. Watch them mix it or they might just walk out the door, thaw what they took away and walk back in and inject you with it. You will not get the results you are hoping for if they have reconstituted it and then refrozen it.
I think that we all knew the answer to this one, I just wanted to make sure that Allergan knew that this was happening and that patients should be aware of it also and know what to do if this situation came up and they knew about it. I will mention it at the conference also, as it is a practice that needs to be stopped. I also wonder how often this happens and we are unaware of it and just wondering why our botox didn't work as well that particular time?
Shirley in AR.
Re: Lyn-Allergan Called Me
Hi ShirleyThanks very much for the information. How very interesting and yes, what we thought all along but wanted confirmed. Pity they didn't put it in writing but nevertheless, now we know. My injections have not really taken at all. Perhaps a very slight relief, just the edge taken of it, but in no way satisfactory especially when one is PAYING FOR IT !!!!!! Did I tell you that Allergan here replied briefly saying it should be totally re-imbursed by the Govt. for my condition so when he gets back from holidays in a week or so I will learn more. When I get something in writing (email) from Allergan here re costings AND freezing, I think I will write to this new doctor and enclose all the documentation including your info except perhaps for the last two paragraphs. As he has already said he has never treatd BEB before I don't think he should take offense - if he won't treat me with FRESH botox I shall just find someone else. I do know at least one more ophthalmologist now who uses it so I may write to him also and ask if he uses freshly re-constituted Botox. Will post when I get the information. Lyn
Re: Lyn-Allergan Called Me
Shirley,I would like to commend you for the "work" you are doing on this bulletin board ... researching suspicious treatments, welcoming, and directing people. You have found your new calling in life (although it might not be the hightest paid "job" you've ever had!). Keep up the good work. Sally in North Idaho
Re: Lyn-Allergan Called Me
Hi again ShirleyForgot to mention - I once asked my original doctor why the Botox seemed to work differently various times I had it if I was getting the same dose each time. He said that as it was a 'live' product the quality of it varied. Would this be true?
Lyn
Re: Lyn-Allergan Called Me
i remember discussing this a while back. something about when the patent wore off. other companies could compete but there wouldn't be any uniform testing or quality standards? anyone else remember?
Re: Lyn-Allergan Called Me
good research shirley! i think you should call attention to it!! i doubt that many cosmetic botox injectors are losing any money and there is no logical reason other than greed for this.
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