Page 132 - Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition

Regulatory Considerations in Veterinary Toxicology Chapter | 6 99

VetBooks.ir ABCG2 transporter cause a functional defect of this trans- that the CVM has received from 1987 to April 2013. This
report is currently in the process of development for con-
port protein in cats, leading to dysfunction of the trans-
tinued posting of information.
porter at the blood-retina barrier, accumulation of
photoreactive fluoroquinolones in the retina, and ulti- The CVM utilizes its website to disseminate informa-
mately retinal degeneration and blindness in some cats tion about ADEs and important announcements regarding
(Ramirez et al., 2011). animal drug product safety. One section of the website,
“CVM Updates,” contains brief press releases issued by
the CVM on developments of interest to stakeholders and
Communication of Safety Information
the public. CVM Updates may relate to any topic, but are
FDA-approved animal drug product labeling is the pri- often used to convey information about drug safety issues.
mary source of information about a drug’s safety and Consumer Updates may also be published on the FDA’s
effectiveness, and it summarizes the essential scientific website. For example, in July 2010, the FDA published a
information needed for the safe and effective use of the Consumer Updates article, warning consumers of the dan-
drug. Labeling for prescription animal drug products is gers of inadvertent exposure of children and pets to a top-
directed to healthcare professionals, but may include sec- ical estradiol spray used to treat the symptoms of
tions that are intended for animal owners and that also menopause in women. The CVM had received several
must be FDA-approved. Similar to medication guides for reports of pets exhibiting mammary enlargement and vul-
humans that are commonly distributed with human phar- var swelling in female dogs. Reports had also been
macy prescriptions, Client Information Sheets may be received for children, describing premature puberty and
required by the FDA as part of the approved labeling for breast enlargement in boys and girls. The CVM worked
animal drugs. These are written in “consumer-friendly” together with CDER to develop this safety communica-
language and provide information in easily understood tion (FDA, 2010b).
terms about the benefits and side effects associated with
the use of certain drugs. Examples of animal drugs that Animal Food
include Client Information Sheets as part of the labeling
are the nonsteroidal antiinflammatory drugs intended for A safe animal food supply is essential for the health of
use in companion animals. animals and humans. Among its animal food safety
Certain animal drug labels may be required to bear responsibilities, the CVM monitors and establishes stan-
warnings or precautions as related to human exposure to dards for animal food contaminants, approves safe animal
the product. For example, Regu-Mate (altrenogest) food additives, and manages the FDA’s medicated feed
Solution 0.22% is indicated to suppress estrus in mares. and pet food programs. The CVM carries out its responsi-
The drug label for this product contains specific human bility for the regulation of animal food in cooperation
warnings regarding the potential effects of exposure to the with state and local partners through a variety of mechan-
drug on human female reproduction. There has been no isms: cooperative agreements, contracts, grants, memo-
approved human use of this specific product. The infor- randa of understanding, and partnerships. For instance,
mation contained in the labeling of this product is extrap- the FDA cooperates with the Association of American
olated from data available on other products of the same Feed Control Officials (AAFCO) and the states for the
pharmacological class that have been used in humans. implementation of uniform policies for regulating the use
Effects anticipated are due to the progestational activity of animal food products. This includes the establishment
of altrenogest. Acute effects after a single exposure are of uniform food ingredient definitions and proper labeling
possible; however, continued daily exposure has the to assure the safe use of animal foods. The ingredient
potential for more untoward effects such as disruption of definitions are important because animal foods and ingre-
the menstrual cycle, uterine or abdominal cramping, dients must be correctly and truthfully labeled when they
increased or decreased uterine bleeding, prolongation of enter commerce. Although FDA has the responsibility for
pregnancy, and headaches. regulating the use of these products, the ultimate responsi-
In some cases, if label revisions are made to a product bility for the production of safe and effective animal food
during the postapproval period to update it with new products lies with the manufacturers and distributors of
safety information, the CVM may request that a drug the products.
sponsor issue a “Dear Doctor” letter, which is sent The FFDCA requires that any substance that is added
directly to veterinarians in order to notify them of the to or is expected to become a component of animal food,
new information. Dear Doctor letters issued since 2000 either directly or indirectly, must be used in accordance
are posted on the CVM’s website (FDA/CVM, 2016c). with a food additive regulation unless it is generally rec-
The CVM also maintains a cumulative summary of ADE ognized as safe (GRAS) for that intended use. Typical
reports, which contain a list of clinical signs in the reports food ingredients such as forages, grains, and most