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FDA Suspends Temporary Emergency Permit of Pet Food Maker

From the FDA today:

FDA Suspends Temporary Emergency Permit of Pet Food Maker

June 12, 2009

The U.S. Food and Drug Administration announced today it was suspending the temporary Emergency Permit issued to Evanger’s Dog & Cat Food Co., Inc.

Evanger’s, operating in Wheeling, Illinois, deviated from the prescribed process, equipment, product shipment, and recordkeeping requirements in the production of the company’s thermally processed low acid canned food (LACF) products.  The deviations in their processes and documentation could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.

In April 2008, Evanger’s was issued an “Order of Need for Emergency Permit” after the agency determined that the company had failed to meet the regulatory requirements to process a product that does not present a health risk.   In June, 2008, FDA issued Evanger’s a temporary Emergency Permit.  During inspections conducted between March 2009 and April 2009, FDA determined Evanger’s was not operating in compliance with the mandatory requirements and conditions of the Temporary Emergency Permit.

“The FDA is stopping Evanger’s ability to ship pet food in interstate commerce,” said Dr. Bernadette Dunham. “Today’s enforcement action sends a strong message to manufacturers of pet food that we will take whatever action necessary to keep unsafe products from reaching consumers.”

In order for Evanger’s to resume shipping in interstate commerce, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.

Botulism is a powerful toxin that affects the nervous system and can be fatal. The disease has been documented in dogs and cats. Signs of botulism in animals are progressive muscle paralysis, disturbed vision, difficulty in chewing and swallowing, and progressive weakness to the body. Death is usually due to paralysis of the heart or the muscles used in breathing.

While FDA’s Center for Food Safety and Applied Nutrition is responsible for regulating all human and animal LACF processing, FDA’s Center for Veterinary Medicine has authority over animal feed and foods.  The two centers are collaborating on this enforcement action.

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Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855

June 12, 2009 Posted by | dogs, Pets | , , , | 1 Comment

New treatment for mast cell tumors

poochHere’s some good news reported in The Oregonian this week about a new treatment for mast cell tumors:

Skin-cancer drug approved for dogs

by Jacques Von Lunen, Special to The Oregonian

The U.S. Food and Drug Administration has announced the approval of the first drug developed specifically for the treatment of cancer in dogs.

The drug, Palladia, is manufactured by Pfizer Animal Health. It is approved to treat mast-cell tumors in dogs, a type of cancer responsible for about 20 percent of canine skin tumors, the FDA said in a news release.

While mast-cell tumors are often small, they can be a serious form of cancer in dogs. Some of these tumors are easily removed without further problems, while others can lead to life-threatening disease.

All cancer drugs now used in veterinary medicine originally were developed for use in humans and are not approved for use in animals by the FDA, although since 1994 it has been legal to prescribe certain drugs intended for humans to animals.

Palladia works in two ways: by killing tumor cells and by cutting off the blood supply to the tumor. In a clinical trial, Palladia shrank tumors significantly, compared with a placebo.

The most common side effects associated with Palladia are diarrhea, decrease or loss of appetite, lameness and weight loss.

That’s great news.  I’ve had two dogs that had mast cell tumors.  In both cases they were easily removed but they can appear in places where they are not so easily treated.  Sometiimes the tumors can be so advanced that surgery doesn’t help.  Mast cell tumors are one of the most common forms of cancer in dogs because they occur on the skin.  If you don’t treat them they can make your dog sick in other ways, besides the physical tumor.  The small tumors can produce chemicals that are released throughout your dog’s body.  They can lead to gastric ulcers, nausea and vomiting, internal bleeding, and allergy-type symptoms.

Mast cell tumors seem to occur in all breeds and mixes and no one really knows what causes them.  There’s not much you can do in the way of prevention.  Like some other cancers, they tend to occur more frequently as your dog gets older.

These small tumors can come in different shapes and, once they appear, they can grow.  If your dog has a new, small growth you should have your vet check it out.  They may do a biopsy to see if the growth is cancerous or simply aspirate the growth with a needle to take a few cells.  You can’t tell just by looking at a growth if it’s a mast cell tumor (or cancerous) or not.

The important thing to remember with mast cell tumors, or with any kind of cancer in dogs is that it’s always better to catch it early.  Check your dog regularly for signs of any new growths or strange little protuberances.  Ask your vet about anything new or different about your dog.  Don’t be afraid to ask.  It’s part of your vet’s job to check these things out.

June 12, 2009 Posted by | dogs, Pets | , , , , , | 1 Comment