Adverse Reactions

How to prevent, recognize symptoms, and report allergic reactions to medications and vaccines.  Candid, honest information to protect your dog - and your veterinarian.

Adverse Drug Reactions (ADR) account for nearly 10% of all human hospital admissions.  If pet owners could better recognize the onset of allergic or adverse reactions, admission numbers would explode for animals, but deaths would steeply decline.

© TheDogPlace 2002  / If, when confronted with a drug or vaccine reaction, vets honestly diagnosed and reported adverse events,  animal statistics would more than triple.  What owners must accept is that fear of a malpractice suit in a suit-happy society leads to caution instead of candor.  Most vets react spontaneously and honestly to save a pet.  The bitter truth however is that dead dogs don't talk and necropsy is rarely sought when an animal dies.

JAMA's reports on adverse drug reactions to patients while in the hospital equates to having three World Trade Center collapses every month!  Meanwhile we are bombarded with drug advertisements; "talk to your doctor” to see if (blank) is "right for you."  Your dog can't do that and when there are no prescription inserts to alert you to possible reactions, and no required reporting, your pets are especially vulnerable.

In human medicine, when an allergic or adverse reaction occurs, help is usually as close as the hospital.  The patient can convey critical information to the doctor.  When a dog has an adverse reaction, he may be home alone or outside and thus, symptoms go unnoticed until it is too late.  Even when your dog by your side, he can't tell you what is happening and if symptoms are relatively mild, you may not realize he is having a medication reaction. 

The danger is that having received no prescription insert or client information sheet, you will unknowingly repeat the dose.  What was a mild first reaction can then become an emergency situation.

Symptoms Of Adverse Reactions

Adverse drug (or food) reactions and side effects are usually limited to nausea, loss of appetite, diarrhea, rashes, swelling, and/or lethargy. 

Unlike low tolerance reactions, anaphylactic reaction can occur within minutes but may be delayed for several hours after the causative agent.  Anaphylactic shock is life threatening.  If untreated, anaphylactic shock results in respiratory and cardiac failure, and if not reversed, death.

Vaccines can cause seizures, partial paralysis, or general malaise.  Many people fail to relate vaccines or other injections to the sudden onset of anaphylactic shock and when the adverse reaction is less dramatic, owners are even less likely to connect it to the injection.

Adverse Event Precautions & Medication Records

Always note (on the calendar is good!) when your dog receives a new medication, puppy shot or adult booster and be alert for any side effects for at least 36 hours.

When your pet receives any new medication, orally or by injection, ask your veterinarian for the prescription insert or CIS (client information sheet) and the manufacturer, date, serial number, etc.  This is not being negative, it is being wisely prepared.  Refer to adverse incident statistics above!

How To Report Adverse Drug or Vaccine Reactions - FDA form 1932

If your dog has a reaction, no matter how mild, be sure it is properly reported.  If there is any question about accuracy in the form or to insure the form is properly filed, you and your vet should complete FDA form 1932 and you should send it.  Vets usually rely on staff to make such reports and slipups occur.

FDA states "Pretesting by the manufacturer and review of the data by the government does not guarantee absolute safety and effectiveness due to the inherent limitation imposed by testing the product on a limited population of animals."  Doublespeak is not what you go to the FDA Animal Veterinary Safety website read.

Typical of bureaucratic runaround, the FDA then says "you should first call the drug company to report an ADE..."  ADE is insider lingo for "adverse drug experience."  This tells you that you're off to a slow start.  If you received the prescription insert, the phone number should be on that sheet.  You can call and leave a message stating your animal has had an adverse reaction to their product and you are requesting FDA form 1932.  Someone will call you.

You could call the FDA directly at 1-888-FDA-VETS and leave a message, including the brand name, your phone number, and a request for FDA form 1932.  Better yet, we've provided it; click to print FDA form 1932

No one knows how many beloved pets die each month from adverse reactions to lifesaving veterinary drugs, vaccines, and even dog food.  We hope you will help us continue to protect dogs and inform owners.  to Project: Prescription Inserts & Adverse Reactions or if you have information of a serious adverse reaction, share it here

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An interesting August 2006 sidebar from Jean Sinclair having to do with Animal Suffering & Pfizer: