Client Information Sheets (CIS) for NSAIDs
List of NSAIDs Client Information Sheets and Package Inserts
In this age of information, it is important that pet owners receive
proper information about the drugs prescribed for their pet. The
best source for information is the pet’s veterinarian. Informed
consent is an essential aspect of safe and effective use of medications
in our pets. Veterinarians and pet owners should discuss the benefits
as well as the risks of all medications, and
this includes Non-Steroidal Anti-inflammatory Drugs or NSAIDs.
Pet owners, not wanting their pets to be uncomfortable, are often quite
diligent in administering to their dogs any prescribed pain medications. NSAIDs
are often used for the control of pain and inflammation associated with
osteoarthritis and, in some instances, to control the postoperative pain
associated with some surgical procedures. Therefore, pet owners
should be informed of possible NSAID side effects.
All FDA-CVM approved NSAIDs for use in dogs (there are no oral NSAIDs
approved for use in cats in the US) are packaged with a Client Information
Sheet (CIS), also known as an Owner Information Sheet. Some CISs
are printed on the back of the package insert, some are perforated and
can be torn from the package insert, and many medications come to the
veterinarian with additional tear-off pads of CISs for distribution
to pet owners. These information sheets are written in user-friendly
language intended to provide useful information to pet owners. Pet
owners may refer to CISs while their dogs are receiving an NSAID.
NSAIDs provide many significant benefits to pets. The intent of
the CISs is to inform pet owners of the potential risks associated
with all NSAIDs, to help avoid potential adverse reactions and to educate
owners to watch for certain signs of adverse events in their pets. Pet
owners should be informed to stop administering
any NSAID if a suspected problem arises and to contact their veterinarian
immediately.
The CISs provide pet owners with written information to which
they may refer long after they have left the animal hospital. Often
in veterinary practice, drugs are re-packaged for individual pet dispensing. The
International Veterinary Academy of Pain Management is providing copies
of the Client Information Sheets for NSAIDs on this website as a reference
for pet owners and as a resource for veterinary practices.
If the pet owner and/or veterinarian suspect a reaction associated with
an NSAID (or any other medication), that reaction should be reported
to the pharmaceutical company. All NSAIDs approved for use in dogs
have a toll free number on the package insert and Client Information
Sheet for reporting suspected reactions. If they are unable to
report problems directly to the appropriate pharmaceutical company, veterinarians
and pet owners are encouraged to report veterinary Adverse Drug Experiences
(ADE) and suspected product failures to the government agency that regulates
the product in question. In the case of NSAIDs, adverse drug experiences
may be reported to the Center for Veterinary Medicine (CVM).
Questions regarding ADE Reporting should be addressed to:
Center for Veterinary Medicine
Division of Surveillance, HFV-210
7519 Standish Place
Rockville, MD 20855
1-888-FDA-VETS
Information reported to CVM is often used for updating labeling and
adding “post-approval” language to the package insert. You
can get more information about NSAIDs and other pet medications by going
to CVM’s website, www.fda.gov/cvm/default.html. Once
there, go to the “Greenbook” navigational button, where
you can look up medications by the brand name or active ingredient.
|