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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.

CONTACT US

1-888-963-8471

We are Mon–Fri, 8:30am–8:00pm ET

This site is intended for U.S. Animal Healthcare Professionals. The product information provided in this site is intended only for residents of the United States. The products discussed herein may not have marketing authorization or may have different product labeling in different countries. The animal health information contained herein is provided for educational purposes only and is not intended to replace discussions with an animal healthcare professional. All decisions regarding the care of a veterinary patient must be made with an animal healthcare professional, considering the unique characteristics of the patient.

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