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APVMA RESPONSE TO THE RECALL OF THE VETERINARY MEDICINE ‘PROHEART 6’ IN THE UNITED STATES
10 September 2004
The veterinary medicine manufacturer, Fort Dodge in the United States, has voluntarily recalled ‘ProHeart 6’ a veterinary medicine used to prevent heartworm in dogs, after a request by the US Food & Drug Administration (FDA). The FDA raised concerns over the product’s safety and they will convene an independent scientific committee to review this.
The Australian subsidiary of Fort Dodge has a similar veterinary medicine ‘ProHeart SR-12’ on the Australian market, registered by the Australian Pesticides and Veterinary Medicines Authority, the national regulator of veterinary medicines. ProHeart SR-12 can be used by veterinarians. Although the APVMA has received some adverse experience reports related to the use of ProHeart SR-12 in Australia, the number of reports actually represents only a small fraction of the total number of dogs treated with the product each year (for example during the 2003-2004 financial year this was less than 0.01%). In light of the US recall the APVMA has re-assessed the adverse experience reports it has received related to ProHeart SR-12 and believes that, in light of the small number of reports received, removal of the product from the Australian marketplace is not warranted for this product at this stage.
The APMVA will however be monitoring the FDA actions and will continue to investigate any future adverse experience reports that are received in Australia. We will provide updates on our website if our assessment of the situation alters.
Dr Peter Dagg, the APVMA Adverse Experience Reporting Program Coordinator says, “Under the Adverse Experience Reporting Program, veterinarians, animals owners and other chemical users are encouraged to report any problems that they encounter with the use of veterinary medicines to the APVMA. Product registrants are also requested to provide the APVMA with any adverse experience reports that they become aware of.”
Dog owners who may be concerned about adverse experiences associated with any veterinary medicine should contact their veterinarian. Reports of adverse experiences are published on the APVMA website at:
http://www.apvma.gov.au/qa/aerp2003.pdf (for 2003), and
http://www.apvma.gov.au/qa/aerp1995_2003.pdf (for 1995-2003).
For further APVMA information, contact:
Dr Peter Dagg, Adverse Experience Reporting Program Coordinator
Ph (02) 6272 3651
Media contact:
Dennis O'Leary, APVMA Public Relations Manager
Ph: 02 6272 3797 or Mob: 0408 644245