Author: mom

FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

November 16, 2020

Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to treat non-metastatic MCTs located under the dog’s skin (subcutaneous), in particular areas of a dog’s leg. Stelfonta is injected directly into the MCT (intratumoral injection). Stelfonta works by activating a protein that spreads throughout the treated tumor, which disintegrates tumor cells. Continue reading FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

FDA update on Vitamin D toxicity recalls

More brands have been added to the FDA’s list of pet foods containing dangerous amounts of vitamin D
December 11, 2018

The FDA encourages veterinarians treating vitamin D toxicity to ask their clients for a diet history. Vitamin D toxicity may also present itself as hypercalcemia, similar to when dogs consume rodenticide, the administration warns.

The list of recalled dry dog food products provided to the FDA includes:

Nutrisca Chicken and Chickpea Dry Dog Food (4 lb., 15 lb., and 28 lb.)
Natural Life Pet Products Chicken and Potato Dry Dog Food (17.5 lb.)
Evolve Chicken and Rice Puppy Dry Dog Food (14 lb. and 28 lb.)
Sportsman’s Pride Large Breed Puppy Dry Dog Food (40 lb.)
Triumph Chicken and Rice Recipe Dry Dog Food (3.5 lb., 16 lb., and 30 lb.)
ANF Lamb and Rice Dry Dog Food (3 kg and 7.5 kg)
Lidl Orlando Grain-Free Chicken and Chickpea Superfood Recipe Dog Food
(#215662)
Kroger Abound Chicken and Brown Rice Recipe Dog Food (4 lb., 14 lb., and 24 lb.)
ELM Chicken and Chickpea Recipe (3 lb. and 28 lb.)
ELM K9 Naturals Chicken Recipe (40 lb.)
Nature’s Promise Chicken and Brown Rice Dog Food (4 lb., 14 lb., and 28 lb.)
Nature’s Place Real Country Chicken and Brown Rice Dog Food (5 lb. and 15 lb.)

Nutrisca Issues Recall of Dry Dog Food

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D
Nutrisca, of Saint Louis, Missouri is voluntarily recalling one formula of Nutrisca® dry dog food (described below) due to it containing elevated levels of vitamin D.

4 lbs Nutrisca® Chicken and Chickpea Dry Dog Food Bag UPC: 8-84244-12495-7
15 lbs Nutrisca® Chicken and Chickpea Dry Dog Food Bag UPC: 8-84244-12795-8
28 lbs Nutrisca® Chicken and Chickpea Dry Dog Food Bag UPC: 8-84244-12895-5

The products were distributed to retail stores nationwide.

Nutrisca became aware of the elevated levels of vitamin D after receiving complaints from three pet owners of vitamin D toxicity after consuming the product. An investigation revealed a formulation error led to the elevated vitamin D in the product. Continue reading Nutrisca Issues Recall of Dry Dog Food

Natural Life Pet Products Issues Recall of Dry Food

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D
Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

17.5 lbs. Natural Life Chicken & Potato Dry Dog Food Bag UPC: 0-12344-08175-1

Bags affected have a Best By Date code of May 29, 2020 through August 10, 2020. The Best By Date code can be found on the back or bottom of each bag. Continue reading Natural Life Pet Products Issues Recall of Dry Food

Silver Star Brands Recall PetAlive products

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

PET PRODUCTS
PRODUCT, INDICATION, NDC UPC LOT, EXPIRATION DATE
PetAlive Plump-Up Pet oral spray Improves appetite in underweight dogs and cats 68703-290- 02 818837013908 K011617E 01/20
PetAlive Allergy Itch Ease oral spray Relieves skin itch 68703-135- 59 818837011102 K111617B 11/20

Silver Star Brands, Inc. is notifying its distributors and customers by letter and is arranging for return and replacement (or refund) of the recalled products.

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals and animals. To date, Silver Star Brands, Inc. has not received any reports of adverse events related to this recall. Continue reading Silver Star Brands Recall PetAlive products

Flea & Tick FDA warning

Fact Sheet for Pet Owners and Veterinarians about Potential Adverse Events Associated with Isoxazoline Flea and Tick Products
Fast Facts
The FDA is alerting pet owners and veterinarians of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class.
The FDA-approved drugs in this class are Bravecto, Credelio, Nexgard and Simparica. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations.
Although these products can and have been safely used in the majority of dogs and cats, pet owners should consult with their veterinarian to review their patients’ medical histories and determine whether a product in the isoxazoline class is appropriate for their pet.
What should I know?
The FDA considers products in the isoxazoline class to be safe and effective for dogs and cats but is providing this information so that pet owners and veterinarians can take it into consideration when choosing tick and flea removal products for their pets.
Isoxazoline products have been associated with neurologic adverse reactions, including muscle tremors, ataxia, and seizures in some dogs and cats;
Although most dogs and cats haven’t had neurologic adverse reactions, seizures may occur in animals without a prior history;
Many products are available for prevention and control of flea and tick infestations. You can discuss all options with your veterinarian to choose the right product for your pet.

What products are in the isoxazoline class?
The FDA-approved drugs in this class are
Bravecto
Credelio
Nexgard
Simparica
These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations.

What should I do if my pet has an adverse drug event while using an isoxazoline product?
If your dog or cat experiences any adverse event while using an isoxazoline product, first consult your veterinarian.
The FDA continues to monitor adverse drug event reports for these products and encourages pet owners and veterinarians to report adverse drug events. You can do this by reporting to the drugs’ manufacturers, who are required to report this information to the FDA, or by submitting a report directly to the FDA.To report suspected adverse drug events for these products and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact the appropriate manufacturers at the following phone numbers:
Merck Animal Health (Bravecto): 800-224-5318
Elanco Animal Health (Credelio): 888-545-5973
Merial (Nexgard): 888-637-4251
Zoetis (Simparica): 888-963-8471
If you prefer to report directly to the FDA, or want additional information about adverse drug experience reporting for animal drugs, see How to Report Animal Drug Side Effects and Product Problems (/AnimalVeterinary/SafetyHealth/Repor taProblem/ucm055305.htm).

Pet owners and veterinarians who have additional questions can contact AskCVM@fda.hhs.gov
(mailto:AskCVM@fda.hhs.gov) or call 240-402-7002.
Additional Information
Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products
(/AnimalVeterinary/NewsEvents/CVMUpdates/ucm620934.htm)
More in Animal Health Literacy
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CVM Kid’s Page (/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm136153.htm) Continue reading Flea & Tick FDA warning

United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew for Dogs Due to Possible Chemical Contamination

United Pet Group, a division of Spectrum Brands, Inc. is voluntarily recalling multiple brands of packages of rawhide dog chew products that were distributed to retail outlets and sold online in the U.S. The recall involves the brands and products described below.

The recall was initiated after  United Pet Group identified that certain of its rawhide chew manufacturing facilities located in Mexico and Colombia, as well as one of its suppliers in Brazil, were using a quaternary ammonium compound mixture as a processing aid in the manufacturing of rawhide chews. The compound is an anti-microbial chemical that is approved for cleaning food processing equipment, but it has not been approved in the U.S. as a processing aid in the production of rawhide chews for dogs.

Continue reading United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew for Dogs Due to Possible Chemical Contamination