Life after the FDA's powdered glove banOctober 18, 2018In January 2017, the FDA banned the use of powdered gloves. As a result, physicians, nurses, dentists, kitchen workers, and veterinary professionals cannot buy them or use them.
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Animal food companies convicted for selling adulterated, misbranded pet food ingredientsOctober 16, 2018Wilbur-Ellis Company and Diversified Ingredients, Inc., were convicted in federal court after pleading guilty of introducing adulterated and misbranded pet food ingredients into interstate commerce.
FDA issues alert for isoxazoline class of flea, tick productsSeptember 21, 2018The U.S. Food and Drug Administration is alerting veterinarians and pet owners of the potential for neurologic adverse events in dogs and cats when treated with isoxazoline class flea and tick products, including Bravecto, Nexgard, and Simparica. Data received by the agency as part of its routine post-marketing activities indicates that some animals receiving Bravecto, Nexgard, or Simparica have experienced adverse events such as muscle tremors, ataxia, and seizures, said the FDA in a statement. Credelio, another isoxazoline class product, recently received FDA approval. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations. The FDA said it is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events, as they were seen consistently across the isoxazoline class of products. These products continue to be safe and effective for the majority of animals, said the FDA, adding that it carefully reviewed studies and other data on Bravecto, Credelio, Nexgard, and Simparica prior to approval. The agency is asking the manufacturers to change product labeling in order to provide veterinarians and pet owners with the information they need to make treatment decisions …
FDA, Health Canada issue pet product alert for King Bio due to microbial contaminationAugust 29, 2018The Food and Drug Administration and Health Canada are warning pet owners not to use products, including those labeled as homeopathic drug products, made by King Bio Inc. in Asheville, N.C., and labeled as Dr. King's, due to high levels of microbial contamination identified at the manufacturing site. King Bio has expanded a voluntary recall to include all water-based drug products marketed for animals. The FDA and Health Canada recommend consumers stop using and dispose of these products immediately. King Bio manufactures pet products for urinary incontinence and digestion relief. The full list of products is listed on the King Bio website. Pets who use these products could have an increased risk of serious infection that could require veterinary attention due to high levels of microbial contamination, according to the FDA. Pet owners who have purchased these products should contact their veterinarian if they have concerns or observe signs of an infection after use of these products. According to King Bio, after a recent FDA inspection, several microbial contaminants were found in its products, including Burkholderia multivorans, which is a strain of bacteria called Burkholderia cepacia complex that can cause illness …
FDA approves NexGard expanded label claimsAugust 22, 2018Merial, part of Boehringer Ingelheim, received approval from the U.S Food and Drug Administration to expand the label claims for NexGard (afoxolaner). The flea and tick control product is now approved to prevent Borrelia burgdorferi infections as a direct result of it killing Ixodes scapularis vector ticks, commonly called black-legged, or deer, ticks. NexGard is the first and only flea and tick product to receive FDA approval for preventing infections that cause Lyme disease by killing the vector ticks, the company stated. The approval comes just as veterinarians and pet owners in many parts of the country are being warned about the potential of an increased number of Lyme disease cases in 2018. The FDA approval is based on two well-controlled laboratory studies that showed that NexGard effectively prevented the transmission of B. burgdorfei infections after dogs were infested with wild-caught I. scapularis ticks 28 days after treatment with NexGard, said the manufacturer. "Both studies measured the transmission of B. burgdorferi to dogs after exposure to infected ticks," said Zach Mills, DVM, head of US Pet Veterinary Professional Services. "All dogs treated with NexGard tested negative for B. burgdorferi infection, demonstrating that transmission was prevented as a direct result …
FDA five-year plan to combat rising threat of antibiotic overuseAugust 3, 2018In its ongoing effort to combat antimicrobial resistance, the U.S. Food and Drug Administration (FDA) announced it will implement a five-year blueprint outlining the administration's strategy to "advance antimicrobial stewardship in veterinary settings." As part of the FDA's regulatory mission, its Center for Veterinary Medicine (CVM) is responsible for ensuring the safety and effectiveness of animal drugs, including antimicrobials. Progress has been made, but additional work is needed to address the complex challenge of antimicrobial resistance, the organization said in a statement. "At FDA, we believe that the concept of antimicrobial stewardship encompasses several important principles of judicious use," said FDA Commissioner Scott Gottlieb, MD. "These are critical to slowing the rate at which bacteria develop resistance to antimicrobial drugs. In simple terms, we believe medically important antimicrobial drugs should only be used when necessary to treat, control or prevent disease. In addition, when such use is necessary, these antimicrobials should be used in an optimal manner. They should only be used under the oversight of a licensed veterinarian." The administration's plan, which will cover fiscal years 2019 - 2023, will focus three goals: Aligning antimicrobial drug product use with the principles of antimicrobial stewardship Supporting …
Increase in DCM in dogs may be linked to dietJuly 19, 2018Instances of canine dilated cardiomyopathy may be correlated to specific ingredients in pet foods, says the U.S. Food and Drug Administration.
FDA warns of possible bone treat dangersNovember 30, 2017U.S. Food and Drug Administration (FDA) said in a statement that it has received about 68 reports of pet illnesses related to processed and packaged "bone treats." A variety of commercially available bone treats for dogs—including treats described as "Ham Bones," "Pork Femur Bones," "Rib Bones," and "Smokey Knuckle Bones"—were listed in the reports. The products may be dried through a smoking process or by baking, and may contain other ingredients such as preservatives, seasonings, and smoke flavorings. "Giving your dog a bone treat might lead to an unexpected trip to your veterinarian, a possible emergency surgery, or even death for your pet," said Carmela Stamper, DVM, a veterinarian in the Center for Veterinary Medicine at the FDA. Illnesses reported Illnesses reported to FDA by owners and veterinarians in dogs that have eaten bone treats have included: Gastrointestinal obstruction (blockage in the digestive tract) Choking Cuts and wounds in the mouth or on the tonsils Vomiting Diarrhea Bleeding from the rectum Approximately 16 dogs reportedly died after eating a bone treat. The reports, sent in by pet owners and veterinarians, involved about 90 dogs (some reports included more than one dog). In addition, FDA received seven reports of product problems, …
FDA withdraws draft guidance regarding animal drug compoundingNovember 14, 2017 The U.S. Food and Drug Administration (FDA) is withdrawing draft Guidance for Industry No. 230, "Compounding Animal Drugs from Bulk Drug Substances," in order to clarify that the agency intends to issue a new draft for public comment next year. The draft guidance issued in May 2015 proposed conditions under which the FDA generally would not take action against the compounding of animal drugs from bulk drug substances, with the goal of making such animal drugs available for patient care without jeopardizing the safety of animals and humans or compromising the animal drug approval process. Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes circumstances exist where there is no approved drug that can be used or modified through compounding to treat a particular animal with a particular condition. In those limited situations, an animal drug compounded from bulk drug substances may be an appropriate treatment option. In developing the new draft, the FDA will carefully consider the issues specific to compounding animal drugs, including the significance of using compounded drugs as a treatment option in various veterinary settings and animal species. FDA will publish the new draft …
SCA Pharmaceuticals issues recall on morphine, fentanylOctober 26, 2017A voluntary recall has been issued by SCA Pharmaceuticals, a sterile compounding company. The recall is for 11 lots of its injectable morphine and fentanyl products due to possible microbial contamination. The products associated with this recall were distributed nationwide to human and veterinary hospitals. The company not received any customer complaints or reports of adverse events related to this issue, the manufacturer stated. SCA Pharmaceuticals is notifying its customers via telephone, email, and the USPS, and is arranging for return/replacement of all recalled products. Customers who have product being recalled should discontinue use immediately and return the product to SCA Pharmaceuticals at SCA Pharmaceuticals, 8821 Knoedl Court, Little Rock, AR 72205. Consumers can contact SCA Pharmaceuticals at 877-550-5059 between the hours of 8 a.m. and 5 p.m. Central Standard Time, Monday through Friday. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online at fda.gov.medwatch/report.htm; to submit by regular mail or fax, download the form at fda.gov/MedWatch/getforms.htm or call (800) 332-1088 to …
