AVMA Home | AVMA Journals Home | JAVMA online | Current JAVMA NewsApril
15, 2004 Minimizing the risk factors associated with veterinary NSAIDs
FDA-CVM offers suggestions based on postmarketing experience
Veterinary practitioners must weigh the serious risks associated with
nonsteroidal, anti-inflammatory drug usage. Specific strategies can be
implemented to reduce the likelihood of harming patients. Moreover,
practitioners can educate their clients by communicating the serious
risks that accompany the benefits of those medications.
Vital to the mission of the Food and Drug Administration's Center for
Veterinary Medicine of fostering public and animal health is its pre-
and postapproval regulation of drug labeling. Label content is
painstakingly crafted during products' approval negotiations and is
based on thorough review of all scientific data submitted to support
claims of safety and effectiveness. That content is amended, as needed,
to communicate postmarketing experience that reflects what happens to
patients in the real world.
Postmarketing experience is reported to the CVM by drug sponsors, as
required by the Code of Federal Regulations governing approved drug
applications. The companies report adverse drug experiences upon
notification by veterinary practitioners, pet owners, and other
stakeholders. The reports are stored in the CVM's Adverse Drug
Experience database and analyzed by clinical veterinarians. They review
the reports and classify the likelihood that clinical signs are or are
not linked to the use of a veterinary drug product.
The four most commonly reported clinical signs are vomiting, anorexia,
depression, and diarrhea. Further down the list of adverse events are
gastric ulceration, intestinal ulceration, renal failure, hepatic
failure, and death. Many of those injuries result from product misuse
and could be prevented by understanding the risks imposed by NSAIDs.
Another safeguard is exercising more judicious use of these products in
such ways as screening patients for hydration and for hepatic or renal
disease, and avoiding any overlapping treatment with other NSAID
products.
Drug risk information is communicated to veterinary practitioners and to
the public through the product labeling. Labeling includes the package
insert, the vial or bottle label, the carton label, the client
information sheet, and some types of promotional materials. Drugs that
come with client information sheets are intended to be dispensed to
clients with the client information sheet accompanying the prescription.
In many cases of adverse drug experiences, pet owners report they never
received the client information sheet from their veterinarian. In the
Jan. 15, 2004, JAVMA, staff at the CVM published an article titled
"Emerging issues regarding informed consent." That article reported
evidence that pet owners are increasingly concerned about risks and
benefits of commonly prescribed veterinary drugs. The article stated
that most of the calls received by the CVM concerning adverse drug
experiences now come from consumers rather than veterinarians.
All FDA-approved veterinary NSAID products have similar risk information
on their labels, including the following:
The products are for use in dogs only.
All dogs should undergo a thorough history and physical examination
before the initiation of NSAID therapy.
Appropriate laboratory tests should be considered to establish
hematologic and serum biochemical baseline data prior to, and
periodically during, administration of any NSAID.
The products may be associated with gastrointestinal, hepatic, and renal
toxicosis.
Concomitant use with other anti-inflammatory drugs, such as other NSAIDs
and corticosteroids, should be avoided or closely monitored.
Patients at greatest risk for renal toxicosis are those that are
dehydrated, are on concomitant diuretic treatment, or have renal,
cardiovascular, and/or hepatic dysfunction.
Many NSAIDs possess the potential to produce GI ulceration.
The risk information is there for good reason. Adverse events reported
to the CVM have included substantial numbers of reports of renal
toxicosis in cats (an extralabel use), and gastric and duodenal
ulceration and perforations. GI injuries occur most commonly in dogs
when higher-than-label doses are administered, following surgical
procedures, and after treatment with more than one product, or when
treatments with different products overlap.
For example, suppose a referring veterinarian treated a patient for
osteoarthritis with product A, and the referral practice treats the
patient with a "postsurgical pain" dose of product B. Did the latter
ensure an adequate washout period for the patient to eliminate product
A? Did they provide fluid support during surgery? The most common
factors predisposing patients to injury are overdose, surgical
anesthesia, and in-tandem administration of another NSAID and/or
corticosteroid.
The following practices could help veterinarians administering NSAIDs to
reduce the likelihood of adverse drug experiences and injuries:
Some products have two dosage levels—one for long-term use for
patients with osteoarthritis; another, higher dosage for short-term,
postoperative pain. Choose dosages strictly according to body weight.
Individualize dosing by titrating the dose to desired effect. (Nies AS.
Principles of therapeutics. In: Hardman JG, Limbird LL, eds. Goodman &
Gilman's the pharmacological basis of therapeutics. 10th ed. New York:
McGraw-Hill Book Co, 2001; 45-65.)
The NSAIDs can be nephrotoxic and hepatotoxic. Screen patients for renal
and hepatic disease, and monitor patients during treatment.
Optimize patients' hydration status. Provide parenteral fluids for
surgical patients. Do not administer NSAIDs to patients that are
dehydrated.
Allow an adequate washout period for patients to eliminate the last
NSAID or corticosteroid they were treated with prior to administering a
new NSAID. The duration that constitutes "adequate" has yet to be
determined. Contact product manufacturers to determine current
recommendations.
Most important—read the label. Understand the risk. Make informed
treatment decisions. Provide client information sheets. Communicate the
important risk information to clients.
If client information sheets did not arrive with a shipment of an NSAID
product, contact the distributor and the manufacturer and request that
they immediately send that information. We encourage you to report this
problem to the CVM as well.
The CVM has a Web site that explains its monitoring program for adverse
events associated with the use of drugs in animals, and provides
reported reactions for veterinary drugs:
www.fda.gov/cvm/index/ade/adetoc.htm. Veterinarians and pet owners can
report adverse drug experiences to the CVM by calling us at (888)
FDA-VETS.
–Dr. Thomas J. Moskal, Office of Surveillance and Compliance, FDA
Center for Veterinary Medicine
Return to top
AVMA Journals | JAVMA News | Discussion Groups | Veterinary Career
Center
Professional Resources | Member Center | Care for Animals | AVMA Home
American Veterinary Medical Association
Copyright © 2004
AVMA Home | AVMA Journals Home | JAVMA online | Current JAVMA NewsApril
15, 2004 Minimizing the risk factors associated with veterinary NSAIDs
FDA-CVM offers suggestions based on postmarketing experience
Veterinary practitioners must weigh the serious risks associated with
nonsteroidal, anti-inflammatory drug usage. Specific strategies can be
implemented to reduce the likelihood of harming patients. Moreover,
practitioners can educate their clients by communicating the serious
risks that accompany the benefits of those medications.
Vital to the mission of the Food and Drug Administration's Center for
Veterinary Medicine of fostering public and animal health is its pre-
and postapproval regulation of drug labeling. Label content is
painstakingly crafted during products' approval negotiations and is
based on thorough review of all scientific data submitted to support
claims of safety and effectiveness. That content is amended, as needed,
to communicate postmarketing experience that reflects what happens to
patients in the real world.
Postmarketing experience is reported to the CVM by drug sponsors, as
required by the Code of Federal Regulations governing approved drug
applications. The companies report adverse drug experiences upon
notification by veterinary practitioners, pet owners, and other
stakeholders. The reports are stored in the CVM's Adverse Drug
Experience database and analyzed by clinical veterinarians. They review
the reports and classify the likelihood that clinical signs are or are
not linked to the use of a veterinary drug product.
The four most commonly reported clinical signs are vomiting, anorexia,
depression, and diarrhea. Further down the list of adverse events are
gastric ulceration, intestinal ulceration, renal failure, hepatic
failure, and death. Many of those injuries result from product misuse
and could be prevented by understanding the risks imposed by NSAIDs.
Another safeguard is exercising more judicious use of these products in
such ways as screening patients for hydration and for hepatic or renal
disease, and avoiding any overlapping treatment with other NSAID
products.
Drug risk information is communicated to veterinary practitioners and to
the public through the product labeling. Labeling includes the package
insert, the vial or bottle label, the carton label, the client
information sheet, and some types of promotional materials. Drugs that
come with client information sheets are intended to be dispensed to
clients with the client information sheet accompanying the prescription.
In many cases of adverse drug experiences, pet owners report they never
received the client information sheet from their veterinarian. In the
Jan. 15, 2004, JAVMA, staff at the CVM published an article titled
"Emerging issues regarding informed consent." That article reported
evidence that pet owners are increasingly concerned about risks and
benefits of commonly prescribed veterinary drugs. The article stated
that most of the calls received by the CVM concerning adverse drug
experiences now come from consumers rather than veterinarians.
All FDA-approved veterinary NSAID products have similar risk information
on their labels, including the following:
The products are for use in dogs only.
All dogs should undergo a thorough history and physical examination
before the initiation of NSAID therapy.
Appropriate laboratory tests should be considered to establish
hematologic and serum biochemical baseline data prior to, and
periodically during, administration of any NSAID.
The products may be associated with gastrointestinal, hepatic, and renal
toxicosis.
Concomitant use with other anti-inflammatory drugs, such as other NSAIDs
and corticosteroids, should be avoided or closely monitored.
Patients at greatest risk for renal toxicosis are those that are
dehydrated, are on concomitant diuretic treatment, or have renal,
cardiovascular, and/or hepatic dysfunction.
Many NSAIDs possess the potential to produce GI ulceration.
The risk information is there for good reason. Adverse events reported
to the CVM have included substantial numbers of reports of renal
toxicosis in cats (an extralabel use), and gastric and duodenal
ulceration and perforations. GI injuries occur most commonly in dogs
when higher-than-label doses are administered, following surgical
procedures, and after treatment with more than one product, or when
treatments with different products overlap.
For example, suppose a referring veterinarian treated a patient for
osteoarthritis with product A, and the referral practice treats the
patient with a "postsurgical pain" dose of product B. Did the latter
ensure an adequate washout period for the patient to eliminate product
A? Did they provide fluid support during surgery? The most common
factors predisposing patients to injury are overdose, surgical
anesthesia, and in-tandem administration of another NSAID and/or
corticosteroid.
The following practices could help veterinarians administering NSAIDs to
reduce the likelihood of adverse drug experiences and injuries:
Some products have two dosage levels—one for long-term use for
patients with osteoarthritis; another, higher dosage for short-term,
postoperative pain. Choose dosages strictly according to body weight.
Individualize dosing by titrating the dose to desired effect. (Nies AS.
Principles of therapeutics. In: Hardman JG, Limbird LL, eds. Goodman &
Gilman's the pharmacological basis of therapeutics. 10th ed. New York:
McGraw-Hill Book Co, 2001; 45-65.)
The NSAIDs can be nephrotoxic and hepatotoxic. Screen patients for renal
and hepatic disease, and monitor patients during treatment.
Optimize patients' hydration status. Provide parenteral fluids for
surgical patients. Do not administer NSAIDs to patients that are
dehydrated.
Allow an adequate washout period for patients to eliminate the last
NSAID or corticosteroid they were treated with prior to administering a
new NSAID. The duration that constitutes "adequate" has yet to be
determined. Contact product manufacturers to determine current
recommendations.
Most important—read the label. Understand the risk. Make informed
treatment decisions. Provide client information sheets. Communicate the
important risk information to clients.
If client information sheets did not arrive with a shipment of an NSAID
product, contact the distributor and the manufacturer and request that
they immediately send that information. We encourage you to report this
problem to the CVM as well.
The CVM has a Web site that explains its monitoring program for adverse
events associated with the use of drugs in animals, and provides
reported reactions for veterinary drugs:
www.fda.gov/cvm/index/ade/adetoc.htm. Veterinarians and pet owners can
report adverse drug experiences to the CVM by calling us at (888)
FDA-VETS.
–Dr. Thomas J. Moskal, Office of Surveillance and Compliance, FDA
Center for Veterinary Medicine
Return to top
AVMA Journals | JAVMA News | Discussion Groups | Veterinary Career
Center
Professional Resources | Member Center | Care for Animals | AVMA Home
American Veterinary Medical Association
Copyright © 2004