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  Discussion on Pergolide being withdrawn from the market
Author Message
Member:
gingin

Posted on Monday, Apr 2, 2007 - 8:22 pm:

I just heard today that the FDA announced that the manufacturers of Pergolide are voluntarily withdrawing this drug from the market.
https://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
Member:
freshman

Posted on Monday, Apr 2, 2007 - 11:31 pm:

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?
Member:
scooter

Posted on Thursday, Apr 5, 2007 - 6:40 am:

This was in The Horse about the pergolide....for anyone interested.
https://www.thehorse.com/ViewArticle.aspx?ID=9317
Moderator:
DrO

Posted on Thursday, Apr 5, 2007 - 11:43 am:

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
Moderator:
DrO

Posted on Thursday, Apr 19, 2007 - 8:42 am:

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As you may be aware, the FDA has withdrawn the drug pergolide from the market for use in humans.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
Member:
cheryl

Posted on Thursday, Apr 19, 2007 - 9:32 am:

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
Moderator:
DrO

Posted on Thursday, May 10, 2007 - 10:45 am:

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
Member:
boomer

Posted on Thursday, May 10, 2007 - 1:30 pm:

ok, what is this?
Moderator:
DrO

Posted on Friday, May 11, 2007 - 10:58 am:

Patricia, the article explains this.
DrO
Moderator:
DrO

Posted on Tuesday, May 15, 2007 - 9:34 am:

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
Member:
wgillmor

Posted on Tuesday, May 15, 2007 - 4:25 pm:

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

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