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Safety and ProHeart® 6 (moxidectin)

Keeping Your Canine Patients Safe

Working to ensure patient safety is a factor with any medication or procedure. ProHeart® 6 (moxidectin) is no exception.

Five-Year Safety Update4

(July 2008–June 2013)

  • More than 3.5 million doses sold during reporting period
  • 0.045% adverse event cases reported (4.5/10,000)
  • These results parallel the international experience with ProHeart 6

Safety in Special Populations

ProHeart 6 has been evaluated and found safe in conjunction with many other veterinary medications and in special populations, including:

  • Pregnant and lactating females and breeding males
  • Ivermectin-sensitive Collies
  • Puppies ≥6 months of age

RiskMAP (Risk Minimization Action Plan) Update

In 2013, certain RiskMAP restrictions for ProHeart 6 were lifted. Now:

  • No age restrictions on dogs ≥6 months of age.
  • A pet owner’s consent signature is not required.
  • Veterinary technicians and assistants also can administer ProHeart 6 under the direction of a ProHeart 6–certified veterinarian.
  • A free, 20-minute online ProHeart 6 certification course is required for all practice members who will be administering ProHeart 6.
  • Veterinarians and staff must be certified before they can order ProHeart 6.
IMPORTANT SAFETY INFORMATION: PROHEART 6 should be used in healthy dogs. Do not administer to sick, debilitated, underweight dogs or dogs that have a history of weight loss. Prior to administration, PROHEART 6 certified veterinarians should continue to assess patient health through a medical history, physical examination and if deemed appropriate, diagnostic testing. Continue to use caution when administering PROHEART 6 concurrently with vaccinations. Adverse events, including anaphylaxis, have been reported following the concomitant use of PROHEART 6 and vaccines. In some cases, anaphylactic reactions have resulted in death. Use with caution in dogs with pre-existing or uncontrolled allergic disease (food allergy, atopy or flea allergy dermatitis). Dogs receiving PROHEART 6 should be tested for existing heartworms as per the product label. In people, avoid PROHEART 6 contact with eyes. If contact with the eyes occurs, rinse thoroughly with water for 15 minutes and seek medical attention immediately. PROHEART 6 is available only to veterinarians through a restricted distribution program. Only certified veterinarians and staff can administer it. To obtain additional information including a copy of the product labeling, click here or call 1-888-ZOETIS1 (963-8471).
  1. Login JA, Morton TR, Thebo-Park R. Technical bulletin: ProHeart® 6 (moxidectin) 5-year pharmacovigilance safety update.
    Zoetis Inc.; 2014.
  2. Market Dynamics, Inc. June 2004 monthly heartworm market sales report.

More About the RiskMAP Update

The ProHeart 6 RiskMAP was developed by Zoetis and the FDA to ensure safe, appropriate use to achieve maximum benefits of heartworm disease prevention while minimizing risk to dogs.

  • The FDA agreed to revisions of this RiskMAP in 2013, based on a review of safety history over a 4.5-year period.
  • ProHeart 6 demonstrated predictable safety and efficacy that remained consistent while its usage levels increased dramatically.
  • These data show that ProHeart 6 is a safe and effective product for the prevention of canine heartworm disease.
  • The specifics of the RiskMAP are reviewed in a 20-minute training program readily accessible at www.proheart6training.com.

History of ProHeart® 6 (moxidectin)

2001 ProHeart 6 is introduced in the United States.
2002 Decision is made to only use batches of technical material with undetectable residual solvents for manufacturing of product.
2003 1 of every 5 dogs on heartworm disease preventatives is receiving ProHeart 6 injections.5
2004 The FDA expresses concerns regarding consumer reports of adverse events. ProHeart 6 is voluntarily withdrawn from the U.S. market to further evaluate its safety profile.
2005‑2007 The ProHeart 6 safety profile is found to be similar to that of current oral heartworm preventatives.
2008 ProHeart 6 is reintroduced in the United States using a RiskMAP (Risk Minimization Action Plan).
2008‑2013 ProHeart 6 maintains a predictable, expected adverse event profile that remains consistent as product use steadily increases.
2013 The RiskMAP is revised, allowing use in healthy dogs older than 7 years, permitting administration by certified veterinary staff and removing a client consent signature requirement.
Today Zoetis continues education on the proper use of ProHeart 6. More than 30,000 veterinarians and clinical staff have been certified to administer it.