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"Dear Doctor" Letters

"Letters issued to veterinary medicine professionals by drug manufacturers alerting the professionals to important safety information."

Some examples - note, there are more recent ones at the FDA/CVM Web Page listed above.

 

Excerpted from the How would WE know if a medication prescribed for our Companion turns out to be ineffective or dangerous? Well, this is HOW IT WORKS Web Page

(edited with highlights/bold type/italics, for emphasis)

"CVM is likely to ask the drug sponsor to make labeling changes or take other steps, such as sending a “Dear Doctor” letter to its client-veterinarians, if certain trigger points appear in the database. (To see “Dear Doctor” letters, go to CVM’s website and search using that term.)

For instance, if certain adverse experience signs show up frequently in the database, and the causality scores are in the possible-to-probable range, CVM officials are likely to contact the drug sponsor about label changes or other steps.

Also, if the scores are in the definite range and the adverse experience is severe, such as death, CVM officials are likely to ask the manufacturer to take some steps, even though the adverse events are not frequent.

Sometimes the ADE finding leads the company to revise the label—for instance to add safety warnings or to highlight information already there. And often the company will send out the “Dear Doctor” letter highlighting the change for veterinarians."

 

FDA "Warning Letters"

 

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