3 goldens
03-31-2006, 10:56 PM
Okay, this is copied from the Health Canada VDD. As we read it, they are allowing PH6 to stay on the market with new labels and warnings. The 3rd paragraph, as we understand it, says it is to be given only to dogs that can not be given other heartworm preventatives for some reason. It seems Canada does not think it is all that safe either.
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Home > Drugs & Health Products > Veterinary Drugs > Adverse Drug Reactions (ADRs)
An Update on the Safety Evaluation of ProHeart®6 Sustained Release Injection
February 2006
Health Canada's Veterinary Drugs Directorate (VDD) has been working with Wyeth Animal Health, the manufacturer of ProHeart®6, to investigate the safety of this product. VDD's Pharmacovigilance Unit requested data from the manufacturer regarding the safety of this product under the recommended conditions of use. VDD has received and evaluated the data and recommends:
specific changes to the approved label of ProHeart®6, and
that Wyeth Animal Health notify veterinarians of these changes.
Wyeth Animal Health has revised the label to reflect Health Canada's safety concerns. The following advisory statement has been added to the Cautions section of the label and package insert:
Because of its potential for serious adverse drug reactions and the absence of identifiable risk factors associated with those reactions, ProHeart®6 is only indicated for those dogs in which alternative preventatives cannot be effectively administered.
In addition, the label provides information for veterinarians about Canadian and international adverse drug reactions to ProHeart®6.
Wyeth Animal Health is also preparing a continuing education letter regarding the label revisions which will be distributed to veterinarians in the near future.
ProHeart®6 will, therefore, remain on the market and continue to be available to veterinarians across Canada.
************************************************** *******
Home > Drugs & Health Products > Veterinary Drugs > Adverse Drug Reactions (ADRs)
An Update on the Safety Evaluation of ProHeart®6 Sustained Release Injection
February 2006
Health Canada's Veterinary Drugs Directorate (VDD) has been working with Wyeth Animal Health, the manufacturer of ProHeart®6, to investigate the safety of this product. VDD's Pharmacovigilance Unit requested data from the manufacturer regarding the safety of this product under the recommended conditions of use. VDD has received and evaluated the data and recommends:
specific changes to the approved label of ProHeart®6, and
that Wyeth Animal Health notify veterinarians of these changes.
Wyeth Animal Health has revised the label to reflect Health Canada's safety concerns. The following advisory statement has been added to the Cautions section of the label and package insert:
Because of its potential for serious adverse drug reactions and the absence of identifiable risk factors associated with those reactions, ProHeart®6 is only indicated for those dogs in which alternative preventatives cannot be effectively administered.
In addition, the label provides information for veterinarians about Canadian and international adverse drug reactions to ProHeart®6.
Wyeth Animal Health is also preparing a continuing education letter regarding the label revisions which will be distributed to veterinarians in the near future.
ProHeart®6 will, therefore, remain on the market and continue to be available to veterinarians across Canada.