Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Product Safety Information

Product Safety Information

                        Adverse Event Reports for Animal Drugs and Devices
          Animal Drug Shortage Information
          Arsenic-based Animal Drugs
          Bovine Somatotropin (bST)
          Letters to Veterinary Professionals
          Risk Minimization Action Plans (RiskMAPs) for Approved Products
          Steroid Hormone Implants Used for Growth in Food-Producing Animals
          Veterinary Medication Errors
          Veterinary Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Home
          Animal & Veterinary
          Safety & Health
          Product Safety Information
          Risk Minimization Action Plans (RiskMAPs) for Approved ProductsProduct Safety Information Risk Minimization Action Plans (RiskMAPs) for Approved Products
  
  	
    Share
    Post
    Linkedin

    Email
    PrintWhen a drug has unusual risks but also has unusual benefits, the Sponsor may voluntarily implement a Risk Minimization Action Plan (RiskMAP).
	RiskMAPs use tools such as provider training and certification programs, informed owner consent, and enhanced Pharmacovigilance programs to achieve specific goals and objectives designed to minimize the risk while preserving the benefit of the drug. The Center for Drug Evaluation and Research published a guidance which describes how a RiskMAP has been utilized for human drugs.
	RiskMAPs have evaluation plans to periodically assess the effectiveness of the RiskMAP and whether it is achieving it goals.
	The RiskMAP documents for certain approved products are listed below:RISK MINIMIZATION ACTION PLAN (RiskMAP) FOR:

PROHEART® 6 (moxidectin) for extended-release injectable suspension (NADA 141-189)
and 
PROHEART® 12 (moxidectin) for extended-release injectable suspension (NADA 141-519)

Persons using assistive technology may not be able to fully access information in this RiskMAP. For assistance, please email AskCVM@fda.hhs.gov or call 240-402-7002.

For more information about these products, visit our Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal Drugs page.

                                                                                  Content current as of:
      04/19/2023Product Safety Information

          
                        Adverse Event Reports for Animal Drugs and Devices
          Animal Drug Shortage Information
          Arsenic-based Animal Drugs
          Bovine Somatotropin (bST)
          Letters to Veterinary Professionals
          Risk Minimization Action Plans (RiskMAPs) for Approved Products
          Steroid Hormone Implants Used for Growth in Food-Producing Animals
          Veterinary Medication Errors
          Veterinary Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop