Were you caught out by the Adequan shortage?


Adequan
Adequan is currently not being manufactured while Luitpold Pharmaceuticals addresses FDA concerns with its Shirley, NY facility. The drug will likely not be available until 2014.

Yesterday, Luitpold, the manufacturer of Adequan (R) announced that they would not have product available until the first quarter of 2014. Originally, the company predicted the product would come on line again this July. For many horse and dog owners, that’s really bad news because the drug is almost impossible to find. Even worse, there’s now a shortage of Pentosan as Adequan users have bought up inventory of Wedgewood’s product.

According to a press release from Luitpold:

Luitpold’s NY facility has undergone significant renovations and upgrades to meet enhanced quality standards and address observations made by the U.S. Food And Drug Administration (FDA). These renovations required cessation of manufacturing and affected Luitpold’s ability to release product. This has resulted in shortages in the marketplace.

Luitpold remains committed to resuming its manufacture of Adequan products. We understand how critically important the Adequan brands are to the health and well-being of the animals receiving treatment. The company’s latest expectations for reestablishing Adequan supply to the market is estimated to be first quarter 2014 however, this hinges upon completion of a successful inspection by the FDA.

The truth may be a bit more complicated. In 2011 the FDA cited Luitpold Pharmaceuticals for “significant” manufacturing violations, for injectable drugs (not Adequan). According to an article in Fierce Pharma,

The FDA letter to Luitpold Pharmaceuticals cites “significant” violations–and in a second round of inspections to boot. The facility had been inspected in February and March and then shut down in April for fixes, but the FDA wasn’t satisfied with the results. In fact, Luitpold-made products–distributed by American Regent–have been recalled several times this year, some of them because drug vials contained visible particles.

The key problem is particulates found in injectable drugs. The agency said Luitpold’s failures to fully investigate particulates and look into product failures were “repeat violations” that cropped up in annual inspections since 2008, Dow Jones reports. The Daiichi unit said it believes it has dealt with “most if not all” of the manufacturing shortfalls pointed out by the FDA.

It seems that the Shirley facility has been experiencing issues since 2008 with particulates in the product. IN addition 17 lots of vasopressin injection, which is used to prevent and treat abdominal distention following surgery, were recalled because they were below potency limits and might not be effective for the entire shelf-life.
Adquan is currently the only FDA-approved intramuscular Polysulfated Glycosaminoglycan (PSGAG) treatment for degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. Other products such as Chondroprotec, Polyglycan, etc. are not FDA approved for IM use so injecting them is considered “off label”, this means that the long-term affects of the drug for this use have not been studied.
I am very glad to not have a horse on Adequan or Pentosan right now. What about you? Is the shortage affecting your horse(s)? Are you now trying “off label” treatments to fill in the gap? Has it impacted your competition schedule?
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2 thoughts on “Were you caught out by the Adequan shortage?

  1. My OTTB just had surgery for an OCD lesion on her stifle. Part of the follow-up treatment is a course of Adequan, but the surgeon forgot that he didn’t have any. Then they said they could get me Pentosan, went to call the pharmacy, and said, “…. Actually, maybe not.” So I called my regular vet in a panic, and she was like, “I got you. I have a few boxes of Adequan from before they stopped distributing it.” I’m so relieved that she was thinking ahead like that, and that my girl can have the shots she needs.

  2. Andrea Wayne

    February 2014 now and still NO Adequan! What’s the story Luitpold! I think there’s more to this story than they’re telling us!

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