Reporting Adverse Drug Reactions

With a new drug such as Deramaxx®, it is vitally important that all unexpected and adverse reactions be reported to the manufacturer or the Center for Veterinary Medicine of the Food and Drug Administration.

The easiest way to report this information is for your veterinarian to call Novartis. Manufacturers of drugs are required to provide CVM with full details of every adverse reaction.

The identity of owners is confidential:

The identities all persons and animals is held in strict confidence by FDA and protected to the fullest extent of the law. The reporter's identity may be shared with the manufacturer or distributor unless requested otherwise. However, FDA will not disclose the reporter's identity to a request from the public, pursuant to the Freedom of Information Act.

Novartis Animal Health can be reached at: 1-800-332-2761.

The Center for Veterinary Medicine provides two ways to report: One is to file a written FDA Form 1932a. The other is to call the CVM at: 888-FDA-VETS.

Full details on reporting an Adverse Event to the FDA may be obtained from the CVM.