Pergolide Gourmeds

SWEDESBORO, N.J., May 24 /PRNewswire/ -- The March 29 voluntary withdrawal of pergolide mesylate, a drug used to treat Parkinson's disease, is having an unintended but serious side effect in barns, stables and pastures throughout the United States. The drug was withdrawn voluntarily by two manufacturers who supply it because it was reported to carry a risk of serious heart-valve damage in humans. But equine veterinarians also prescribe the drug for horses with equine Cushing's Syndrome to prevent the type of painful laminitis that ultimately resulted in the death of Barbaro, the thoroughbred who shattered his leg in the last year's Preakness Stakes. Removing pergolide from the market has left veterinarians scrambling to find alternative -- and legal -- sources of this critical medicine.

Wedgewood Pharmacy, one of the nation's largest compounding pharmacies, has become a key source for the drug, providing it in suspension form and in naturally flavored, chewable Gourmeds(TM) tablets, by veterinary prescription only.

Under the Animal Medicinal Drug Use Clarification Act of 1994, veterinarians are permitted to prescribe drugs intended for human use in "extra-label" uses in animals. According to the FDA's Center for Veterinary Medicine (CVM), compounding pergolide from bulk substances for animal use is permitted in response to a valid veterinary prescription to treat an affected horse. The FDA is sufficiently concerned about the situation that it has announced that it will "work with sponsors interested in seeking approval of a new animal drug application for the use of pergolide to treat Cushing's Syndrome in horses."

George Malmberg, R.Ph., FACA, the pharmacist president and CEO of Wedgewood Pharmacy noted, "It is precisely because of circumstances such as this that compounding pharmacies are an indispensible component of the healthcare system."

About Wedgewood Pharmacy

Wedgewood Pharmacy is the largest veterinary compounding pharmacy in the United States, serving more than 20,000 prescribers of animal and human compounds. A compounding pharmacy creates customized medications for individual patients in response to a licensed practitioner's prescription.

Background: About Compounding

Because every patient is different and has different needs, customized, compounded medications are a vital part of quality medical care.

The basis of the profession of pharmacy has always been the "triad," the patient-physician-pharmacist relationship. Compounding is extremely important to the veterinary community, which often requires more flavors, dosages and strengths than commercially available medications supply. Through this relationship, patient needs are determined by a doctor, who chooses a treatment regimen that may include a compounded medication. Physicians and veterinarians often prescribe compounded medications for reasons that include (but are not limited to) the following situations:

  -- When needed medications are discontinued by or generally
     unavailable from pharmaceutical companies, often because the
     medications are no longer profitable to manufacture;
  -- When the patient is allergic to certain preservatives, dyes or
     binders in available off-the shelf medications;
  -- When treatment requires tailored dosage strengths for patients with
     unique needs (for example, an infant);
  -- When a pharmacist can combine several medications the patient is
     taking to increase compliance;
  -- When the patient cannot ingest the medication in its commercially
     available form and a pharmacist can prepare the medication in
     cream, liquid or other form that the patient can easily take; and
  -- When medications require flavor additives to make them more
     palatable for some patients, most often children and pets.

For additional information, visit the International Academy of Compounding Pharmacists' Web site at http://www.iacprx.org/ and http://www.compoundingfacts.org/ .

  Marcy Kelly
  Vice President, Marketing
  mkelly@wedgewoodpharmacy.com
  856.832.1303

  David Kirk, APR, Fellow PRSA
  davidkirk@thePRguy.com
  610.422.0048