Novartis Animal Health U.S. Inc.’s Deramaxx (deracoxib) received U.S. Food and Drug Administration approval for control of postoperative pain and inflammation associated with dental surgery in dogs, the company has reported.

Deramaxx was previously approved for the control and inflammation associated with canine osteoarthritis, and a clinical field study of 62 dogs showed the product to also be effective for canine dental surgery pain and inflammation. Dogs in the study received either a placebo or 1-to-2 mg of Deramaxx per kg of body weight at least one hour prior to surgery, and again for two more days. Among dogs that received Deramaxx, 14.8 percent required additional pain medication compared with 66.7 percent of dogs that received the placebo. The study used a modification of the Glasgow Composite Pain Scale to assess and measure pain prior to surgery and again at regular intervals following dental extractions.

Side effects that are normally mild, but possibly serious, involving the digestive system, kidneys or liver may occur with the use of Deramaxx, the company said. The product should not be used with other non-steroidal anti-inflammatory drugs or corticosteroids.

Merial has released a video showcasing the proper use of its Vet Jet transdermal vaccination system in response to a September advisory of a possible fracture risk associated with the use of the device on kittens.

The Vet Jet is the exclusive delivery system for Merial’s Purevax Recombinant Feline Leukemia Vaccine. The U.S. Food and Drug Administration issued the advisory following three adverse event reports involving the use of the product. In two of those cases, the respective users may have failed to properly lock the device’s nozzle into place before using it, causing the nozzle to dislodge and fracture the each kitten’s femur.

The nearly 13-minute long video features instructions on the proper steps involved with using the Vet Jet. More than 90 seconds of the video are dedicated to instructions on properly locking the nozzle into place, including the following warning:

“A nozzle that is not seated and locked securely may detach itself with significant force upon injection, which could cause injury to the cat or clinic staff.”

The video also includes instructions on assembling the system, operating the plunger and identifying the proper injection site. It is available for download here until Dec. 24, 2011.

Advanced Animal Nutrition recalled several lots of its dry Dog Power Dog Food due to aflatoxin levels above the acceptable limit.

The company is the third to recall food due to aflatoxin in the past week, following recalls from Procter & Gamble and Cargill.

The affected products were manufactured between Jan. 4, 2011, and Nov. 18, 2011, and include:

• Dog Power Adult Maintenance Formula 21-12 Dog Food, 50 lb. bags;

• Dog Power Hunters Formula 27-14 Dog Food, 50 lb. bags;

• Dog Power Hi-Pro Performance Formula 26-18 Dog Food, 50 lb. bags.

The recall applies to the above products with Packaging Date Codes [lot numbers] K0004 through K1322. The affected products were distributed in Missouri, Arkansas and Louisiana. Retailers have been instructed to remove the affected brands and products from their shelves.

The company said consumers should return affected products, whether opened or unopened, to their place of purchase for a full refund. They can also call 1-866-648-7646 for more information.

Advanced Animal Nutrition said it implemented the recall as a precautionary measure, and no adverse health effects related to these products have been reported.

Aflatoxins are produced by toxigenic strains of Aspergillus flavus and A. parasiticus on peanuts, soybeans, corn and other cereals, either in the field or during storage when moisture content and temperatures are sufficiently high for mold growth, according to the Merck Veterinary Manual. High doses of aflatoxins result in severe hepatocellular necrosis, and prolonged low dosages result in reduced growth rate and liver enlargement. Pets that have consumed the affected product and are exhibiting symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian, the company said.

BioVeteria Life Sciences, LLC (BioVeteria) announced they have partnered with IMULAN BioTherapeutics, LLC to distribute a new 60-count version of LeukoSTAT®. LeukoSTAT® contains a patented, orally active amino acid complex termed the Immune Selective Anti-Inflammatory Derivatives, or ImSAIDs®. The ImSAIDs® aid in modulating leukocyte related inflammatory conditions and have been studied in a variety of inflammatory models including pancreatitis, endotoxemia, asthma, anaphylaxis, and arthritis. BioVeteria has started programs to examine LeukoSTAT® for intestinal and oral health in cats and dogs where leukocyte (lymphocyte, plasmacyte, granulocyte) activity is considered a primary factor.

Targeting leukocyte activation and transmigration is becoming a popular target for inflammatory intervention since leukocytes participate and coordinate all inflammatory events. The ImSAIDs® are a new class of naturally occurring immuno-nutritional complexes that help support a reduction in leukocyte over-activation. In a recent edition of the Journal of Inflammation [1], the immuno-pharmacology of the ImSAIDs® is reviewed in detail and discusses the novel immunological mechanisms which includes reduction in over-exuberant immune cell activation (leukocytes, granulocytes) and their production of reactive oxygen species.

[1] Mathison et al.: Salivary gland derived peptides as a new class of anti-inflammatory agents: review of preclinical pharmacology of C-terminal peptides of SMR1 protein. Journal of Inflammation 2010 7:49 ; Hyperlink to Paper: http://www.journal-inflammation.com/content/7/1/49

Cargill Animal Nutrition has recalled two regional brands of dog food—River Run and Marksman—due to aflatoxin levels that were detected above the acceptable limit.

The recalled products were manufactured at Cargill’s Lecompte, La., facility between Dec. 1, 2010, and Dec. 1, 2011.

No illnesses have been reported in association with these products to date, and no other Cargill Animal Nutrition pet food products are involved in this recall, Cargill reported.

The affected products are:

• Professional Formula River Run Hi-NRG 24-20 Dog Food, 50-pound bags
• River Run Professional Formula 27-18 Dog Food, 50-pound bags
• River Run 21% Protein Dog Food, 40- and 50-pound bags
• River Run Hi-Pro No-Soy Dog Food, 40- and 50-pound bags
• Marksman Dog Food 24% Protein 20% Fat, 40-pound bags
• Marksman Dog Food 20% Protein 10% Fat, 40- and 50-pound bags
• Marksman Dog Food 28% Protein 18% Fat, 40-pound bags

The recall only applies to the above products with the following packaging date codes (lot numbers): 4K0335 through 4K0365, LL0335 through LL0365, 4K1001 through 4K1335 and LL1001 through LL1335.

The affected dry dog food products were distributed in the following 15 states/territories – Kansas, Missouri, Northeast Oklahoma, Arkansas, Louisiana, Mississippi, Tennessee, Western Kentucky, Southeast Indiana, Southern Illinois, Hawaii, Guam, the U.S. Virgin Islands and limited areas of Florida and California.

Retailers have been instructed to remove the affected brands and products from store shelves. Consumers are urged to return affected products—whether in opened or unopened packages—to their place of purchase for a full refund.

Aflatoxin  is a naturally occurring mold by-product. Pets that have consumed any of the above recalled products and exhibit symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian.

Cargill encouraged consumers to go to the company’s website or call 855-460-1532 for more information.

Cargill’s recall follows the recent dog food recall by The Procter and Gamble Co. P&G voluntarily recalled a single-production lot of Iams Proactive Health Smart Puppy dry dog food due to aflatoxin levels detected above the acceptable limit.

FLAVORx, a supplier of medication compliance solutions for people and pets, has announced a major enhancement to their veterinary line. The new Digital Flavorist software gives veterinarians and pharmacists complete veterinary compounding and flavoring instructions with just a few quick keystrokes. Following the recipes generated by the Digital Flavorist, veterinarians and pharmacists can easily turn solid-form medications into flavored liquids, which most pets are more likely to take without a fight.

“The Digital Flavorist is a major improvement to the FLAVORx Veterinary System,” said Chad Baker, vice president of marketing at FLAVORx. “For pet owners who struggle to give pills to their cat or dog, a flavored liquid form of the medication can be a godsend. The Digital Flavorist makes it easy for vets and pharmacists to provide this invaluable service to their patients.”

Since the FLAVORx Veterinary system was first introduced in 1997, millions of prescriptions have been compounded and flavored for pet owners. Grilled Tuna, Chicken Pot Pie, Crispy Bacon and Red Angus Beef are just a few of the FLAVORx flavor options available for nearly all veterinary medications. Based on the species of pet, the veterinarian or pharmacist can make recommendations on which flavors will work best for each medication. Pet owners can also look up the top flavors for their pet on the web-based Favorable Flavors Guide.

When a veterinary hospital or pharmacy decides to offer the FLAVORx service to their customers, they receive all the tools, flavors, and guidance needed to turn pills into flavored liquids and make a positive impact on pet medication compliance. With the Digital Flavorist, formulating the compounding and flavoring recipes, once considered a labor-intensive process, has been reduced to a few quick and easy steps.

The UK-based manufacturer and distributor of animal health products Animalcare Ltd has been reprimanded by the National Office of Animal Health (NOAH) trade body for a breach of its Code of Practice for the Promotion of Animal Medicines.

On the 16th of September 2011 Animalcare were found to be in breach of Clause 18.2 for offering and supplying infusion pumps/equipment in exchange for veterinary practices entering into written contracts for the purchase of a range of their products including their POM-V Benazecare®.

On the 18th of October 2011 Animalcare were reprimanded by the Board of NOAH for their conduct as they had failed to comply with the requirements of the Rules of Procedures for the Code of Practice and this Press Release was issued.

The NOAH Board of Management required Animalcare to submit the information originally requested by the Code of Practice Committee Secretary, which Animalcare duly did. The information confirmed that the equipment was offered: its value equated to the discount agreed with the veterinary practice, which was applied as the medicinal products were purchased. The equipment was supplied on the signing of a contract. The terms of the contract required a particular quantity of medicinal products to be purchased, and if the veterinary practice failed to meet that requirement, there was a liability to pay a pro-rata element of the equipment purchase price.

To assist the Board in its deliberations, the Code of Practice Committee reconvened on the 8th of November to consider the information now supplied by Animalcare. The Committee were of the view that this new information would not have made any difference to their earlier decision, which was that a piece of equipment was neither ‘price’ nor ‘product’ within the meaning of Clause 18.2 of the Code of Practice; and as such amounted to a gift being offered in relation to the sale; or purchase; or prescription of animal medicine.

Furthermore the Committee took into account that Guidance Note 4, paragraph 7, states that the word “gift” includes any pecuniary advantage being offered, with the exception of price or product itself.

In short, to comply with Code of Practice Clause 18.2, the offer or inducement based on price had to be one of cash as rebated discount. If then there were facilities to enable the veterinary practice to use that rebated discount to purchase the equipment from the supplier, that might be acceptable, but there was a necessity for cash as rebated discount to be provided in the first instance.

Animalcare were required to sign the Undertaking in its original form and this signed document has now been received.

NOAH encourages those interested in finding out more to read the full details of the Committee’s rulings on the NOAH website at www.noah.co.uk/code. The full report of this particular case will be available shortly.

The Procter and Gamble Co. voluntarily recalled a single-production lot of Iams Proactive Health Smart Puppy dry dog food due to aflatoxin levels detected above the acceptable limit, the Cincinnati-based company has reported.

The product has been retrieved from store shelves, and no illnesses have been reported in association with the lot to date, according to the company. The recall includes Iams Proactive Health Smart Puppy dry dog food with Use By or Expiration Dates of Feb. 5 or 6, 2013 and the following attributes:

The affected product lot was distributed to retailers in the Eastern U.S., including the following states: Alabama, Connecticut, Delaware, Florida, Georgie, Lousiana, Maryland, Maine, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina and Virgina. Consumers who purchased the product should stop using it and contact Iams for a replacement voucher, the company said.

Aflatoxins are produced by toxigenic strains of Aspergillus flavus and A. parasiticus on peanuts, soybeans, corn, and other cereals either in the field or during storage when moisture content and temperatures are sufficiently high for mold growth, according to the Merck Veterinary Manual. High doses of aflatoxins result in severe hepatocellular necrosis, and prolonged low dosages result in reduced growth rate and liver enlargement. Pets that have consumed the affected product and are exhibiting symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian, the company said.

Bayer HealthCare LLC, Animal Health Division has reached successful settlements in its trademark infringement cases against India-based Cipla Ltd. and Vanuatu-based Archipelago Suppliers, the company has announced. Both companies have entered into settlements and agreed to immediately stop selling products that infringe Bayer’s Advantage® and Advantix® trademarks and disgorge profits from such sales.

Bayer manufactures a number of leading pet products, including the popular flea preventatives, Advantage® II and K9 Advantix® II. Bayer recently became aware of Cipla’s manufacture of an infringing product, DA Double Advantage, and of sales by various websites to U.S. consumers, in violation of Bayer’s Advantage® trademark rights. The company sought a preliminary injunction to quickly block any further illegal sales into the country.

As a result of the settlement, Cipla agreed to discontinue all use of the DA Double Advantage trademark (in the U.S. and on a global basis). Cipla will also: stop use of the trademark Advance for a companion animal product; refrain from manufacturing any product with the same formula as Bayer’s patented Advantix® (Global) and K9 Advantix® II (U.S.) products during the remaining term of those patents; and disgorge its total profits from the sale of DA Double Advantage, in excess of $100,000. Cipla also paid an additional $100,000 to reimburse Bayer for attorneys’ fees and agreed to recall any product remaining in the sales pipeline.

A similarly successful outcome was achieved with respect to Archipelago Suppliers, which agreed to a Consent Decree. Under the Court’s order, Archipelago Suppliers, operator of several websites at issue, is prohibited from selling DA Double Advantage or any product with the same formulation as DA Double Advantage. The Consent Decree also prohibits Archipelago Suppliers from selling Advantix® into the U.S.

U.S. Marshals, at the request of the FDA, recently seized all dietary supplements by a Wisconsin maker for false claims made about their safety and effectiveness in treating a number of diseases.

The products manufactured at the Hillsboro, Wis., facility of Syntec Inc. are not FDA-approved and a complaint filed in the United States District Court for the Western District of Wisconsin alleges that several of Syntec Inc.’s products are unapproved new drugs that may not be introduced into interstate commerce and are misbranded in violation of the Federal Food, Drug, and Cosmetic Act.

The government alleges that the company claimed in videos and promotional materials that some of its products could be used to prevent, treat, or cure diseases such as asthma, cardiovascular disease, cataracts, glaucoma and infections. The products are not FDA-approved as safe and effective for treating any diseases.

The company’s dietary supplements are sold under several brand names including SynBio, SynOPC, BoneCare, SynBio-X, SynOPC-X, VisionCare, CardioCare, SynGevity, SynVita, SynCell, SynPhyto-K, DigestiveCare, JointCare and SynOmega.

According to the complaint, the company also failed to follow the current good manufacturing practice (cGMP) requirements for dietary supplements, as required by federal law.

The FDA sent the company a warning letter regarding the disease claims in March 2009. During inspections in October and November 2010, June 2011 and September 2011, FDA investigators documented serious cGMP violations, in addition to the company’s continued use of disease claims for some of its products.