Animal Drug Safety-Related Labeling Changes
This online resource provides information on recently approved safety-related labeling changes for animal drugs from January 2021 forward in an effort to improve transparency and communication with veterinarians and the public.
When adverse events are reported or safety concerns are identified for an animal drug, the FDA may work with the sponsor to revise the labeling to reflect this information. This webpage includes safety-related labeling changes initiated by the company or the FDA. Awareness of these safety-related labeling changes is essential for the safe use and administration of FDA-approved animal products.
There is often a lag between the approval of labeling changes and the new labeling becoming available in the marketplace. You can check this webpage for recent safety-related labeling changes as it will be updated on a monthly basis when changes to the drug labeling are approved by the FDA. Safety-related labeling change information will be available here for two years after it is first listed.
For more information about the most current labeling for a particular animal drug, veterinarians should reach out to the drug’s sponsor.
Disclaimer
This reflects recently approved safety-related labeling changes approved by the FDA. The labeling for an approved animal drug, such as its carton or package insert, might not reflect the changes for a year or more in the marketplace as the drug company distributes its inventory of the drug with labeling printed prior to the approval of the labeling changes.
Any reference to a commercial product, process, service, or company is not an endorsement or recommendation by the U.S. government, the Department of Health and Human Services, the FDA or any of its components. The FDA is not responsible for the contents of any non-FDA website referenced by or linked to the agency's website.
Indications for Use: For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing’s Disease) in horses.
Summary of Changes: Labeling was revised to update the Human Warnings section.
The following safety-related changes were made to the labeling:
Human Warnings:
(Additions and/or revisions underlined)
Not for use in humans. Do not ingest the product. Keep this and all medications out of the reach of children. PRASCEND should not be administered by persons who have had adverse reactions to ergotamine or other ergot derivatives.
Pergolide, like other ergot derivatives, may cause emesis, dizziness, lethargy or low blood pressure.
Pregnant or lactating women should wear gloves when administering this product. It has been reported that pergolide tablets may cause eye irritation, an irritating smell, or headache when PRASCEND Tablets are split or crushed. PRASCEND Tablets should not be crushed due to the potential for increased human exposure and care should be taken to minimize exposure when splitting tablets. Store this product separately away from human medicinal products and handle this product with care to avoid accidental ingestion. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
Indications for Use: Control of American Foulbrood caused by Paenibacillus larvae, and European Foulbrood caused by Melissococcus plutonius susceptible to oxytetracycline.
Summary of Changes: The labeling was updated to improve the clarity of the instruction for safe use in honey bees.
The following safety-related changes were made to the labeling:
- The Terramycin 100MR Type A medicated article labeling was revised to improve the clarity of the instructions for safe use in honey bees. These revisions address the three modes of feeding Terramycin 100MR Type A medicated article to honey bees: dusting, syrup, and extender patty.
- The Type C Medicated Feed Blue Bird label for Terramycin 100MR was revised to reflect the revisions to the Type A medicated article labeling.
- Directions for the feeding of Terramycin 100MR medicated syrup and extender patties were added to the Type C Blue Bird labels and reflect the revisions to the Type A medicated article labeling.
- The Veterinary Feed Directive (VFD) for Terramycin 100MR for honey bee use was revised to reflect the revisions to the Type A and Type C labeling.
Indications for Use: Control of American Foulbrood caused by Paenibacillus larvae, and European Foulbrood caused by Melissococcus plutonius susceptible to oxytetracycline.
Summary of Changes: The labeling was updated to improve the clarity of the instruction for safe use in honey bees.
The following safety-related changes were made to the labeling:
- The labeling for the TM-100D and TM-50D Type A medicated articles was revised to improve the clarity of the instructions for safe use in honey bees. These revisions address the three modes of feeding TM-100D and TM-50D Type A medicated articles to honey bees: dusting, syrup, and extender patty.
- The Type B and Type C Medicated Feed Blue Bird labels for TM-100D and TM-50D were revised to reflect the revisions to the Type A medicated article labeling.
- Directions for the feeding of TM-100D and TM-50D medicated syrup and extender patties were added to the Type C Blue Bird labels and reflect the revisions to the Type A medicated article labeling.
- A revised Veterinary Feed Directive (VFD) for honey bee use is consistent with the labeling revisions for the drug.
Indications for Use: For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
Summary of Changes: Labeling revised to emphasize prevention of ocular injury in humans and dogs, that the product should not be used in cats, and to add a post-approval experience section.
The following safety-related changes were made to the labeling:
- The statement “Do not use in Cats” was added was added to the product identification.
- Dosage and Administration:
(Additions and/or revisions underlined)
OSURNIA should be administered by a veterinary professional.
Wear eye protection when administering OSURNIA (see Human Safety Warnings, Precautions, Post-Approval Experience, Animal Safety).
Splatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure.
1. Clean and dry the external ear canal before administering the initial dose of the product.
2. Verify that the tympanic membrane is intact prior to each administration (see Precautions, Contraindications, Animal Safety, Post-Approval Experience).
3. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
4. Open tube by twisting the soft tip. Insert the flexible tip into the affected external ear canal(s) and squeeze entire tube contents into the external ear canal(s). After application, gently massage the base of the ear to allow the gel to penetrate to the lower part of the ear canal.
5. Restrain dog to minimize post application head shaking to reduce potential for splatter of product and accidental eye exposure in people and dogs (see Post-Approval Experience, Animal Safety).
6. Do not clean the ear canal for 45 days after the initial administration to allow contact of the gel with the ear canal. Cleaning the ear may affect product effectiveness (see Effectiveness). If alternative otic therapies are required, it is recommended to clean the ear(s) before application. - WARNINGS:
(Additions and/or revisions underlined)
Human Safety Warnings:
OSURNIA may cause eye injury and irritation (see Precautions, Post-Approval Experience, Animal Safety).
In case of accidental eye contact, flush thoroughly with water for at least 15 minutes. If symptoms develop, seek medical advice.
Not for use in humans. Keep this and all medications out of the reach of children. Consult a physician in case of accidental ingestion by humans. In case of accidental skin contact, wash area thoroughly with water. - PRECAUTIONS:
(Additions and/or revisions underlined)
Wear eye protection when administering OSURNIA and restrain the dog to minimize post application head shaking. Reducing the potential for splatter of product will help prevent accidental eye exposure in people and dogs and help to prevent ocular injury (see Human Safety Warnings, Post-Approval Experience, Animal Safety).
The use of OSURNIA in dogs with perforated tympanic membranes has not been evaluated. The integrity of the tympanic membrane should be confirmed before administering this product. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment.
Proper patient selection is important when considering the benefits and risks of using OSURNIA. The integrity of the tympanic membrane should be confirmed before administering each dose of this product.
Changes to the middle ear such as ulceration of the mucosal lining have been associated with OSURNIA administration (see Animal Safety).
Signs of tympanic membrane rupture, internal ear disease such as head tilt, ataxia, nystagmus, facial paralysis, and keratoconjunctivitis sicca have also been reported (see Post-Approval Experience).
Do not administer orally.
Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see Animal Safety).
Use with caution in dogs with impaired hepatic function (see Animal Safety and Adverse Reactions).
The safe use of OSURNIA in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated. - The following Post-Approval Experience section was added to the labeling:
Post-Approval Experience Section (2020):
The following adverse events are based on post-approval adverse drug experience reporting for OSURNIA. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data.
In humans, accidental exposure leading to corneal ulcers and other ocular injuries such as eye irritation, burning, stinging, and itchiness have been reported to occur when the dog shook its head after application of OSURNIA.
In dogs, the adverse events reported for OSURNIA are presented below in decreasing order of reporting frequency:
Deafness, ear discharge, pinnal irritation and ear pain, emesis, head shaking, internal ear disorder (head tilt and vestibular), ataxia, vocalization, corneal ulcer, keratoconjunctivitis sicca, nystagmus, tympanic rupture, and cranial nerve disorder (facial paralysis).
OSURNIA is not approved for use in cats. The adverse events reported following extra-label use in cats are presented below in decreasing order of reporting frequency:
Ataxia, anorexia, Horner’s syndrome (third eyelid prolapse and miosis), internal ear disorder (head tilt and vestibular), anisocoria, lethargy, head shake, emesis, nystagmus, deafness, and tympanic rupture. - The following Information for Dog Owners section was added to the labeling:
INFORMATION FOR DOG OWNERS:
Owners should be aware that adverse reactions may occur following administration of OSURNIA and should observe dog for signs such as deafness, ear pain and irritation, vomiting, head shaking, head tilt, incoordination, eye pain and ocular discharge (see Animal Safety and Post-Approval Experience). Owners should be advised to contact their veterinarian if any of the above signs are observed.
Owners should also be informed that splatter may occur if the dog shakes its head following administration of OSURNIA which may lead to ocular exposure. As a result, eye injuries in humans and dogs have been reported including corneal ulcers. Owners should be careful to avoid ocular exposure (see Precautions, Post-Approval Experience). - The following Contact Information section was added to the labeling:
CONTACT INFORMATION:
To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Dechra at 1-866-933-2472.
For additional information about adverse drug experience reporting for animal drugs, contact the FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.
Indications for Use: For control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Summary of Changes: Labeling revised to reflect that Apoquel modulates the immune system, new neoplastic conditions have been observed during clinical studies and reported in the post-approval period, and to add a post-approval experience section.
The following safety-related changes were made to the labeling:
- The drug class “Immunomodulator” was added to the product identification.
- Warnings (Additions and/or revisions underlined)
Warnings:
APOQUEL is not for use in dogs less than 12 months of age (see Animal Safety).
APOQUEL modulates the immune system. APOQUEL is not for use in dogs with serious infections.
APOQUEL may increase susceptibility to infection, including demodicosis, and exacerbation of neoplastic conditions. (see Precautions, Adverse Reactions, Post-Approval Experience and Animal Safety).
New neoplastic conditions (benign and malignant) were observed in dogs treated with APOQUEL during clinical studies and have been reported in the post-approval period (See Adverse Reactions and Post-Approval Experience).
Consider the risks and benefits of treatment prior to initiating APOQUEL in dogs with a history of recurrent serious infections or recurrent demodicosis or neoplasms (see Adverse Reactions, Post-Approval Experience, and Animal Safety).
Keep APOQUEL in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. - Newly added Post-Approval Experience and Contact Information sections:
Post-Approval Experience (2020)
The following adverse events are based on post-approval adverse drug experience reporting for APOQUEL. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.
The following adverse events reported in dogs are listed in decreasing order of reporting frequency.
Vomiting, lethargy, anorexia, diarrhea, elevated liver enzymes, dermatitis (i.e. crusts, pododermatitis, pyoderma), seizures, polydipsia, and demodicosis.
Benign, malignant, and unclassified neoplasms, dermal masses (including papillomas and histiocytomas), lymphoma and other cancers have been reported.
Death (including euthanasia) has been reported.
Contact Information:
To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae
Indications for Use: For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius)
Summary of Changes: Labeling revised to emphasize prevention of ocular injury in humans and dogs, that the product should not be used in cats, and to add a post-approval experience section.
The following safety-related changes were made to the labeling:
- The statement ‘Do Not Use in Cats’ was added to the product identification.
- The following statements and graphic were added to the Dosage and Administration section:
Wear eye protection when administering CLARO®. (see Human Warnings, Precautions, Post Approval Experience).
Splatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure.
Verify the tympanic membrane is intact prior to administration. (see Contraindications, Precautions, Post Approval Experience).
Restrain the dog to minimize post application head shaking to reduce potential for splatter of product and accidental eye exposure in people and dogs (see Post Approval Experience).
-
Human Warnings
(Additions and/or revisions underlined)
Human Warnings:
CLARO® may cause eye injury and irritation (see Precautions, Post Approval Experience).
If contact with eyes occurs, flush copiously with water for at least 15 minutes. If irritation persists, contact a physician.
Humans with known hypersensitivity to any of the active ingredients in CLARO® should not handle this product.
Not for use in humans. Keep this and all drugs out of the reach of children. Avoid skin contact. In case of accidental ingestion by humans, contact a physician immediately. -
Precautions
(Additions and/or revisions underlined)
Precautions:
For use in dogs only. Do not use in cats (see Post Approval Experience).
Wear eye protection when administering CLARO® and restrain the dog to minimize post application head shaking. Reducing the potential for splatter of product will help prevent accidental eye exposure in people and dogs and help to prevent ocular injury (see Dosage and Administration, Human Warnings, Post Approval Experience).
Proper patient selection is important when considering the benefits and risks of using CLARO®. The integrity of the tympanic membrane should be confirmed before administering the product.
CLARO® has been associated with rupture of the tympanic membrane. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment.
Signs of internal ear disease such as head tilt, vestibular signs, ataxia, nystagmus, facial paralysis, and keratoconjunctivitis sicca have been reported (see Post Approval Experience) with the use of CLARO®.
Do not administer orally.
Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see Animal Safety).
Use with caution in dogs with impaired hepatic function (see Animal Safety).
The safe use of CLARO® in dogs used for breeding purposes, during pregnancy, or
in lactating bitches, has not been evaluated. -
The following Post-Approval Experience section was added to the labeling:
Post Approval Experience Section (2019):
The following adverse events are based on post-approval adverse drug experience reporting for CLARO®. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.
In humans, accidental exposure leading to corneal ulcers and other ocular injuries such as eye irritation and redness have been reported. Exposure occurred when the dog shook its head after application of CLARO®. Skin irritation has also been reported.
In dogs, the adverse events reported are presented below in decreasing order of reporting frequency:
Ear discharge, head shaking, ataxia, internal ear disorder (head tilt and vestibular), deafness, emesis, nystagmus, pinnal irritation and ear pain, keratoconjunctivitis sicca, vocalization, corneal ulcer, cranial nerve disorder (facial paralysis), tympanic membrane rupture.
CLARO® is not approved for use in cats. The adverse events reported following extra-label use in cats are presented below in decreasing order of reporting frequency:
Ataxia, anorexia, internal ear disorder (head tilt and vestibular), Horner’s syndrome (third eyelid prolapse and miosis), nystagmus, lethargy, anisocoria, head shake, emesis, tympanic rupture, and deafness.
To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Bayer HealthCare at 1-800-422-9874.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae. -
The following Information for Dog Owners section was added to the labeling:
Information for Dog Owners:
Owners should be aware that adverse reactions may occur following administration of CLARO® and should be instructed to observe the dog for signs such as ear pain and irritation, vomiting, head shaking, head tilt, incoordination, eye pain and ocular discharge (see Post Approval Experience). Owners should be advised to contact their veterinarian if any of the above signs are observed.
Owners should also be informed that splatter may occur if the dog shakes its head following administration of CLARO® which may lead to ocular exposure. Eye injuries, including corneal ulcers, have been reported in humans and dogs associated with head shaking and splatter following administration. Owners should be careful to avoid ocular exposure (see Precautions, Post Approval Experience).
In addition, the following safety-related changes were made to the language on the packaging.
1. The statement ‘Do Not Use in Cats’ was added.2. The statement ‘Wear eye protection when administering CLARO®’ was added.