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Discussion on Pergolide being withdrawn from the market

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Christine Sizemore
Member
Username: gingin

Post Number: 78
Registered: 11-2003
Posted on Monday, Apr 2, 2007 - 8:22 pm:   Edit PostPrint Post

I just heard today that the FDA announced that the manufacturers of Pergolide are voluntarily withdrawing this drug from the market.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html.
What other options will there be for us horse owners? Does anyone know how the veterinary community deals with withdrawals like this?

Thanks much!
Christine
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Kristin
Member
Username: freshman

Post Number: 59
Registered: 1-2007
Posted on Monday, Apr 2, 2007 - 11:31 pm:   Edit PostPrint Post

Compounded pergolide should still be available, unless I am mistaken. I think that most horse folks, at least that I know, obtain their their pegolide in compounded form already. Will have to check to see if this has any affect on these sources. Perhaps someone else has already researched this?
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Diane Edmonds
Member
Username: scooter

Post Number: 826
Registered: 9-2000
Posted on Thursday, Apr 5, 2007 - 6:40 am:   Edit PostPrint Post

This was in The Horse about the pergolide....for anyone interested.
http://www.thehorse.com/ViewArticle.aspx?ID=9317
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Robert N. Oglesby DVM
Moderator
Username: dro

Post Number: 18172
Registered: 1-1997
Posted on Thursday, Apr 5, 2007 - 11:43 am:   Edit PostPrint Post

Hello All,
For the past week we have been monitoring this issue and Right now there is nothing known about what will happen to the availability of pergolide to horseowners. We have updated the article to address this issue along with suggestions of what you should be doing right now just in case the product completely disappears from the market.
DrO
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Robert N. Oglesby DVM
Moderator
Username: dro

Post Number: 18279
Registered: 1-1997
Posted on Thursday, Apr 19, 2007 - 8:42 am:   Edit PostPrint Post

I just received this from the AAEP:

Dear AAEP Members:

As you may be aware, the FDA has withdrawn the drug pergolide from the market for use in humans. In order for the drug to continue to be available for use in veterinary medicine, the FDA must approve an exception for pergolide to be used by veterinarians and to be compounded in bulk quantities.

The AAEP, through its Drug Compounding Task Force, has been in contact with the FDA, and they are aware of the significant impact of pergolide’s withdrawal from the market on equine medicine. The FDA Center for Veterinary Medicine is working with its counterpart for human medicine, the Center for Drug Evaluation and Research, to allow importation of pergolide for use by compounding pharmacies. The FDA expects to have an official announcement by the end of this week.

The AAEP will continue to communicate with the FDA on this issue.


I will keep you updated.
DrO
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Cheryl Kallenbach
Member
Username: cheryl

Post Number: 300
Registered: 2-2000
Posted on Thursday, Apr 19, 2007 - 9:32 am:   Edit PostPrint Post

I just had Lady's prescription for pergolide refilled. The lady I spoke with said the FDA had blocked shipment to one of the large compounding pharmacy. So unless the AAEP is successful - we will be out of pergolide in the very near future.
Cheryl
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Robert N. Oglesby DVM
Moderator
Username: dro

Post Number: 18437
Registered: 1-1997
Posted on Thursday, May 10, 2007 - 10:45 am:   Edit PostPrint Post

Though there continues to be work on this by the AAEP they are reporting they remain unsuccessful at this time and my understanding is that supplies are running low. See article for possible solutions.
DrO
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Patricia Bell
Member
Username: boomer

Post Number: 257
Registered: 1-2006
Posted on Thursday, May 10, 2007 - 1:30 pm:   Edit PostPrint Post

ok, what is this?
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Robert N. Oglesby DVM
Moderator
Username: dro

Post Number: 18440
Registered: 1-1997
Posted on Friday, May 11, 2007 - 10:58 am:   Edit PostPrint Post

Patricia, the article explains this.
DrO
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Robert N. Oglesby DVM
Moderator
Username: dro

Post Number: 18460
Registered: 1-1997
Posted on Tuesday, May 15, 2007 - 9:34 am:   Edit PostPrint Post

Good news from the AAEP:

Update on pergolide availability in the U.S.
The AAEP has, for the past several years, been working closely with the Center for Veterinary Medicine at the Food and Drug Administration to understand the policies governing compounding as it relates to equine practice. As a result of the recent withdrawal of pergolide from the market due to human health concerns, the AAEP contacted the FDA in an effort to educate and emphasize the importance of this drug to equine practitioners and their clientele.

The AAEP feels, after receiving this communication, that there will not be a crisis due to a pergolide shortage. The FDA recognizes the importance of these drugs and because of a healthy alliance with the AAEP, the Agency learned of the situation quickly and made its decision to apply regulatory discretion to the compounding of pergolide from bulk sources. Compounding pharmacies should not experience any shortage of the bulk product.


I have not yet read the details of the communication but it sounds good so far. I would not let my guard down however and would expect price increases: time to stock up on pergolide is now.
DrO
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Wiley Gillmor
Member
Username: wgillmor

Post Number: 66
Registered: 4-2005
Posted on Tuesday, May 15, 2007 - 4:25 pm:   Edit PostPrint Post

Here is the FDA announcement (nothing contradicts DrO's statement above):

http://www.fda.gov/cvm/pergolide.htm
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