Allergan's Response to Inquiry


Posted by Shirley-Arkansas-USA ® , Apr 30,2002,18:45   Archive
A while back Nancy posted a link to an article regarding using saline with a preservative in it when reconstituting BOTOX to lessen the pain of BOTOX injections. The link is below in case you missed seeing the article.

http://my.webmd.com/content/article/1689.52711

I wrote to Allergan and sent them a link to the article and asked for comments on it. This is their response that I received today:

Dear Ms Barr:

Thank you for your interest in Allergan and BOTOX® (Botulinum Toxin Type
A) purified neurotoxin complex. BOTOX® was licensed by the FDA on
December 29, 1989 and is indicated for the treatment of strabismus and
blepharospasm associated with dystonia, including benign essential
blepharospasm or VII nerve disorders in patients 12 years of age and
above, and also for the treatment of cervical dystonia in adults to
decrease the severity of abnormal head position and neck pain associated
with cervical dystonia.

You had an inquiry regarding the use of a preserved saline diluent with
BOTOX®. The recommended diluent is normal saline (0.9%) without
preservative. It is recommended that the product be used within four
hours. Refreezing BOTOX® or BOTOX® Cosmetic after reconstitution is not
recommended.

There are published reports discussing the use of preserved saline
and/or extended storage conditions of product without any apparent
decline in clinical efficacy. Garcia and Fulton (1996) found that
clinical results of 183 cases of patients injected with BOTOX® were the
same for fresh toxin compared to reconstituted toxin stored at
refrigerator temperatures for up to 30 days. Results between BOTOX®
diluted with preserved saline and BOTOX® diluted with non-preserved
saline also showed no significant differences.

Sloop et al. (1997) reported no significant loss in potency after BOTOX®
was reconstituted, then refrozen or refrigerated for 2 weeks before use
by measuring M wave amplitudes (muscle paralysis) in healthy human
volunteers. Gartlan & Hoffman (1993) reported a statistically
significant degradation in potency by the mouse bioassay after 12 hours
of refrigerator storage of BOTOX® but not after 6 hours. They also
demonstrated a statistically significant loss in potency when BOTOX® was
reconstituted, immediately refrozen, thawed and assayed two weeks later

Allergan has conducted studies that demonstrated potency degradation by
the mouse bioassay within 4 hours after reconstitution when benzyl
alcohol preserved normal saline was used as the diluent. (Internal data
on file). Refreezing reconstituted toxin is not recommended as it may
possibly have an effect on the molecular integrity of the molecule that
could impact the pharmacological characteristics of the neurotoxin
complex.

If you need further assistance, please feel free to reply by email, or
contact us at BOTOX® Medical Information at 1-800-433-8871.

Sincerely,
Lee Tyrrell
Medical Information Specialist
Scientific Information and Medical Compliance
Allergan, Inc.
1-800-433-8871, x4553
References:

Garcia A, Fulton JE. Cosmetic denervation of the muscles of facial
expression with botulinum toxin. A dose-response study. Dermatol Surg
1996;22:39-43.

Gartlan MG, Hoffman HT. Crystalline preparation of botulinum toxin type
A (BOTOX®): degradation in potency with storage.Otolaryngol Head & Neck
Surg 1993 Feb;108(2):135-140.

Sloop RR, Cole BA, Escutin RO. Reconstituted botulinum toxin type A does
not lose potency in humans if it is refrozen or refrigerated for 2 weeks
before use. Neurology 1997 Jan;48(1):249-53.

--modified by Shirley-Arkansas-USA at Tue, Apr 30, 2002, 18:47:11




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Re: Allergan's Response to Inquiry

Re : Allergan's Response to Inquiry --- Shirley-Arkansas-USA
Posted by Nancy Williams ® , May 01,2002,08:16 Top of Thread Archive
Good Morning Shirley and thanks for contacting Allergan in reference to the article about an added perservative to the saline to decrease the discomfort of the Botox injections.... the response was very informative but unless I missed something (eyes are not behaving well this morning) they did not mention discomfort.....only that the recommended diluent is normal saline (0.9%)without perservative, and it is to be used within 4 hours. It also mentioned Botox and Botox Cosmetic...Wonder what the difference is?
Hope your eyes are better for you today! and Thanks again.... but Botox injections - discomfort or not-- will remain my treatment until they find a better one.

Nancy/NE. PA. where it is a bright and sunny HAPPY MAY DAY!!!!!




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Re: Allergan's Response to Inquiry

Re : Allergan's Response to Inquiry --- Shirley-Arkansas-USA
Posted by Lyn Patterson ® , May 03,2002,05:40 Top of Thread Archive
Hi Shirley

Thanks for obtaining all this information and passing it on to us. It is very interesting. You may recall when I was "between" doctors and went to the costmetic surgeon who was a friend of my GP and he injected me with FROZEN Botox - it had absolutely no effect whatsoever !

I like to see my doctor getting the stuff ready - then I know it is fresh !

Lyn




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Re: Allergan's Response to Inquiry/Shirley

Re : Allergan's Response to Inquiry --- Shirley-Arkansas-USA
Posted by Kathy in Atlanta ® (kathy,Kathy in Atlanta), May 03,2002,06:28 Top of Thread Archive
Okay then , is this the botox solution that is less painful to inject??



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Re: Allergan's Response to Inquiry/Shirley

Re : Re: Allergan's Response to Inquiry/Shirley --- Kathy in Atlanta
Posted by Ann Doyle ® , May 03,2002,07:28 Top of Thread Archive
I wrote to Allegran after getting my Botox--C 329 number from the lab of the Movement Disorder Clinic 6 months ago. I wasn't concerned about the pain but the fact that it had no effect.
They explained that they always keep it frozen but I was interested in the testing of the potency. That particular month , they had a lot of complaints and my second hand knowledge from the internet said they were giving free 2nd. shots within 2 weeks of the first shot if it didn't work that month. I talked to or emailed my doctors nurse and he said he didn't want to take the chance before the 3 months were up. Never did wrok. I'm the type that wakes up the morning after the shot feeling good but it goes away fast.
I asked others on the internet to get their batch number but no one did as far as I know. . Ann Doyle
The next time, things were back to normal.



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Re: Allergan's Response to Inquiry/Kathy

Re : Re: Allergan's Response to Inquiry/Shirley --- Kathy in Atlanta
Posted by Shirley-Arkansas-USA ® , May 03,2002,10:40 Top of Thread Archive
Kathy, they don't really say. They indicate that some "outside" studies have been done and published but that their (Allergan's) studies did not get the same results.
The link to the article regarding BOTOX being less painful doesn't state what type of preservative was used. I'm not sure what it is.

When Allergan responded, they did not address the issue of the BOTOX being less painful with the preservative. I know that it was brought up before on this bb, that injections with a preservative had been more painful. I don't know the answer to this- one way or the other. The reports seem to be conflicting.

In my own personal experience, the actual BOTOX solution has never really been painful. The injections (or needle pricks) sometimes "smart" briefly and if a large volume of the BOTOX solution is injected in a sensitive area, then that burned. But with small volumes of the solution, it has never hurt me.

I'm also interested in what Allergan mentioned as BOTOX or BOTOX Cosmetic. What's the difference?
I shall have to ask them that.

Shirley in Arkansas where it continues to rain and rain and rain.




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Re: Allergan's Response to Inquiry/Kathy

Re : Re: Allergan's Response to Inquiry/Kathy --- Shirley-Arkansas-USA
Posted by Kathy in Atlanta ® (kathy,Kathy in Atlanta), May 03,2002,13:57 Top of Thread Archive
Wouldn't one assume the dilution would be weaker or less in the Botox cosmetic vials?



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Re: Allergan's Response to Inquiry/Kathy

Re : Re: Allergan's Response to Inquiry/Kathy --- Kathy in Atlanta
Posted by Shirley-Arkansas-USA ® , May 03,2002,14:13 Top of Thread Archive
I don't have a clue if it would be weaker. I was surprised to see them mentioned "separately" as if there was a difference. I intend to email them and ask but am having trouble with the eyes cooperating today so will have to do it later.
Anybody else know?

Shirley in Arkansas with BEB/Apraxia




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Re: Allergan's Response to Inquiry/Kathy

Re : Re: Allergan's Response to Inquiry/Kathy --- Kathy in Atlanta
Posted by Ann Doyle ® , May 03,2002,16:07 Top of Thread Archive
Again second hand information from the net. The potency varies form 80% to 120% (?). I imagine this would be for people who really need it. But if they used 80 and 120. does that mean that some get 10 and some 190 and it averages out to 100. The whole thing doesn't make sense to me. You hurt when the Botox is given and I can't see work or drive for another 3 months. Ann Doyle



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Re: Allergan's Response to Inquiry/Kathy

Re : Re: Allergan's Response to Inquiry/Kathy --- Shirley-Arkansas-USA
Posted by Ann Doyle ® , May 03,2002,16:01 Top of Thread Archive
Shirley, I only wrote to Allegran Co. about quality control and they wrote back about keeping it frozen. I got another letter from Allegran Cosmetic, that I didn't even know existed and the letters were identical. work for word. Ann Doyle



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