June 06, 2008

Deadly ProHeart® 6 Heartworm Prevention in the Market Again

Rabies vaccine is not the only miscreant in the adverse reactions that negatively affect our dogs and cats.

FDA and Fort Dodge are bringing the heartworm preventative ProHeart® 6 back on the market after it was
voluntarily withdrawn by Fort Dodge in 2004 due to “serious, life-threatening adverse reactions. These include loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.”

Reports of adverse reactions and death in dogs injected with this heartworm preventative began in 2002. It was implicated in the death of untold hundreds of dogs before it was pulled in 2004.


An independent website has been created that posts reports of adverse side effects to the ProHeart6 shot. It is updated regularly and can be reached via this link: ProHeartInformation.


For a manufacturer and the FDA, "hundreds of dogs" is not statistically important enough to ban the product entirely. It's the "untold" stories that demand more investigation.

Now it's back with no change in formulation but only revised warning language on the label (which pet owners will never see.)


"ProHeart® 6 is generally well tolerated. Do not use in sick, debilitated or underweight animals, animals with a history of weight loss, or within one month of vaccination. Use with caution in dogs with pre-existing allergic disease. A small percentage of dogs showed mild, transient swelling or itching at the injection site. While rare, allergic, digestive, hematological, or neurological reactions may occur. In addition, death has been reported. ProHeart 6 is available only through a restricted distribution program. Only veterinarians enrolled in this program can receive and administer ProHeart 6. In addition, ProHeart 6 must only be administered to clients whose owners have been advised of the risks of ProHeart 6 and sign an Owner Consent Form. To obtain additional information including a copy of the product labeling, visit the website at www.proheart6dvm. com or call 1-800-533-8536."

Way to go, Fort Dodge. Don't fix the problem; cover your ass.

It is extremely important, if you suspect your dog has had an adverse reaction to ProHeart® 6, that you report both to Fort Dodge Animal Health and to the FDA. The toll-free number for Fort Dodge is: 1.800.533-8536 . You can file a report with the FDA by telephone at: 1-888-332-8387 (or 1-888-FDA-VETS)


or:


You may also report an adverse drug experience using a form that is available on the FDA website. Access to the form is at

http://www.fda.gov/cvm/index/ade/adetoc.htm


Just print out the form, complete it and mail it. It is two-sided and postpaid.


If you you would like to be in touch with others whose dogs have experienced adverse reactions to ProHeart® 6, contact these people:
  • Myra Kirkland, MKirkland@carolina.rr.com
  • Janice Storey, jstorey1@swbell.net
  • You may also wish to join the "doghealth2" E-mail list, which has ongoing discussions about canine medications and health. doghealth2@yahoogroups.com

No comments: