Reevaluating Compounding

Concerns with use of compounded pergolide

Pergolide has been the drug of choice to treat PPID.1 However, until PRASCEND® (pergolide mesylate) became available, no drug specifically has been approved by the FDA for treating horses with PPID in the US. As a result, compounded pergolide mesylate has been the only product available to veterinarians. But now, there is another option—PRASCEND.

Compounded preparations, unlike FDA-approved products, are not supported by clinically controlled studies used to demonstrate safety and efficacy in the labeled animal species for the specified condition.

Furthermore, since they are not approved by the FDA, compounded products are not required to meet consistency in manufacturing specifications between compounding companies or even between each dose. The lack of therapeutic consistency, stability, and quality control requirements present serious concerns for practitioners.2

Studies show inconsistent strength and stability of compounds

In a study conducted by Drs. Stanley and Knych, liquid, capsule, and powder formulations of pergolide mesylate were tested.3 Samples were obtained from 7 compounding pharmacies. Two samples of each formulation were ordered and stored at various temperatures to test the difference in concentration of the active ingredient, pergolide mesylate, over time.

Data provided by Jennifer L. Davis, DVM3
Data provided by Jennifer L. Davis, DVM3

A new choice offers proven stability

FDA-approved PRASCEND offers a reassuring new treatment option. PRASCEND is rigorously tested to be safe and effective for use in horses and ponies to treat clinical signs associated with PPID.4 It's produced by a leading manufacturer in state-of-the-art facilities with strict adherence to manufacturing guidelines. You can count on each batch of PRASCEND to be of the same high quality and strength you expect. When you prescribe PRASCEND, it's easy to calculate just the right amount to give your patients for the results you and your clients want.

and get the latest information on PPID diagnosis and treatment for free.

Important safety information

PRASCEND is for use in horses only. Treatment with PRASCEND has been observed to cause inappetance, with most cases being transient. Weight loss, lethargy, and behavioral changes may be observed in some horses. If severe, a temporary reduction of dose may be necessary. PRASCEND has not been evaluated in breeding, pregnant, or lactating animals. As PRASCEND is a dopamine agonist, it may interfere with reproductive hormones involved in these groups of animals. The concurrent use of dopamine antagonists should be avoided since these agents may diminish the effectiveness of PRASCEND. PRASCEND should not be used in horses with hypersensitivity to pergolide mesylate or other ergot derivatives. Refer to the package insert for complete product information.

References:

  1. McFarlane D. Equine pituitary pars intermedia dysfunction. Vet Clin North AmEquine Pract. 2011;27(1):93-113.
  2. American Veterinary Distributors Association. Veterinary compounding. Available at: http://www.avda.net/compounding2011finalversion.pdf. Accessed August 16, 2011.
  3. Stanley SD, Knych HD. Comparison of pharmaceutical equivalence for compound preparations of pergolide mesylate. Presented at: 56th Annual Convention of the American Association of Equine Practitioners; December 4–8, 2010; Baltimore, MD.
  4. PRASCEND® (pergolide mesylate) [Freedom of Information Summary]. St. Joseph, MO: Boehringer Ingelheim Vetmedica, Inc.; 2011.