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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, October 14, 2021

Bi-partisan bill introduced to change animal testing mandates


WASHINGTON – U.S. senators Rand Paul and Cory Booker introduced the FDA Modernization Act on Thursday to end animal testing mandates.

The bill would end an outdated FDA mandate that experimental drugs must be tested on animals before they are tested on humans in clinical trials. The bill would not ban animal testing outright, but would allow the option for drug sponsors to use alternative methods.

Current mandates were passed in 1938, but since then, research has proven that animal testing is highly inconsistent at predicting toxic responses in humans. Senator Rand Paul says he believes the bill can pass both the House and the Senate without being challenged.

To read more on this story, click here: Bi-partisan bill introduced to change animal testing mandates


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Thursday, August 19, 2021

FDA Says Violations at Pet Food Plants ‘Likely' Contributed to Hundreds of Sick, Dead Dogs


The agency said it is aware of more than 130 pet deaths and more than 220 pet illnesses that are possibly be linked to brands of pet food manufactured by Midwestern Pet Foods

Violations of federal protocols at manufacturing plants that produce multiple brands of pet food, nearly a dozen of which were recalled earlier this year, likely caused hundreds of pets to become ill and die.

The U.S. Food and Drug Administration on Tuesday announced it warned Midwestern Pet Foods, Inc. in a letter that inspectors found the company's food safety program to be inadequate, discovering salmonella and toxic levels of aflatoxin at four of its plants in Chickasha, Oklahoma; Waverly, New York; Evansville, Indiana; and Monmouth, Illinois.

To read more on this story, click here:  FDA Says Violations at Pet Food Plants ‘Likely' Contributed to Hundreds of Sick, Dead Dogs



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Monday, August 16, 2021

Dog Heartworm is Risky to Treat, But Prevention is Key


While heartworm disease is certainly a serious health risk, the good news is that it is also one of the most easily prevented conditions. Monthly heartworm preventives come in convenient oral forms (such as Heartgard Plus or Sentinel) or easily-applied topical applications (such as Revolution).

It is recommend using a heartworm preventive every month year-round. In the long run, maintaining your dog’s heartworm protection is money well spent.

The fact is, heartworm infection is still an extremely serious health concern for your dog, and the risk of it is widespread.

The American Heartworm Society notes that adult heartworm disease has been reported in dogs in all 50 states. Adult heartworm disease can cause severe damage to the heart, lungs and other organs, and can eventually lead to death. While it is true that there is a treatment for adult heartworm disease, the treatment can be costly, requires hospitalization, and is not without the risk of side effects.

The Heartworm Life Cycle depends on the mosquito. When the insect bites an infected dog, it takes in tiny
heartworm larvae (microfilariae) that have been circulating in the animal’s bloodstream. Once inside the mosquito, the microfilariae mature into infective larvae, eventually migrating to the mosquito’s mouthparts, to be transmitted when the insect bites another animal.

In the new host, the larvae continue to develop, eventually migrating through the bloodstream to the lungs, heart and associated vessels, where they cause inflammation  and obstruct blood flow. As the larvae become adult worms, they mate and produce more microfilariae, continuing the cycle. The heartworm life cycle, from larva to adult worm, generally takes about 6 months.

If a dog develops heartworm infection, the drug Immiticide (melarsomine hydrochloride) is the only one that is approved by the FDA for the treatment of adult heartworm disease in dogs. Immiticide is given by deep injection into the muscles of the back, usually in two or three doses over the course of about a month.

As the drug works, dead and dying worms in the heart and lungs can cause an inflammatory reaction in the body. While Immiticide is better tolerated by the body than the previously used drug Caparsolate, the dog must still remain hospitalized during treatment to be observed for the development of possible side effects.

After treatment the dog's activity level must be quite limited to reduce the chance of pulmonary thromboembolism (obstruction of blood flow in the arteries of the lungs, caused by dead heartworms), which can lead to death.

Dogs should be confined to a crate and leash walked outside to eliminate only. Heartworm positive dogs must be exercise restricted from the time of diagnosis until four weeks after the final Immiticide injection.

Follow-up diagnostic testing may be needed after treatment, also. Although treatment will kill the adult heartworms, it cannot repair any damage that they may have done prior to treatment.






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Saturday, September 22, 2018

FDA Warns Common Flea and Tick Meds Linked to Neurological Problems in Dogs and Cats


COLUMBUS, Ohio — The U.S. Food and Drug Administration is alerting pet owners and veterinarians that some flea and tick medications can cause adverse reactions in dogs and cats.

Some animals receiving drugs in the isooxazoline class have experienced adverse events such as muscle tremors, ataxia, and seizures, according to the FDA.

The medicine includes Bravecto, Nexgard, and Simparica. Another product in this class is Credelio, which recently received FDA approval. The FDA says these products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations.

To read more on this story, click here: FDA Warns Common Flea and Tick Meds Linked to Neurological Problems in Dogs and Cats


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Saturday, December 2, 2017

After Dogs Die Eating Packaged Dog Bone Treats, Government Warns Dog Owners About Their Dangers


Our dogs are like our family members and if something ever happened to them we’d be devastated. That’s why the Food and Drug Administration is warning dog owners not to buy bone treats after 15 dogs died from them.

“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,” Carmela Stamper, a veterinarian at the FDA, said according to Business Insider.

The Food and Drug Administration received reports about 15 deaths and 68 reports of dogs who became ill after consuming packaged dog bone treats.

“Veterinarians see many problems related to chewing and ingestion of bones by dogs of all sizes and breeds. Bones can be swallowed whole or they can crack and splinter, leading to choking, vomiting or blockages in the digestive tract,” Spokesperson for the American Veterinary Medical Association Michael San Filippo said. “In extreme cases, splintered bones can perforate a dog’s esophagus, stomach or intestines, which can be fatal without emergency intervention.”

To read more on this story, click here: After Dogs Die Eating Packaged Dog Bone Treats, Government Warns Dog Owners About Their Dangers



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Tuesday, May 3, 2016

Truth About Pet Food


The latest Pet Food privilege announced by the FDA is regarding prescription cat and dog food. All pet food consumers and veterinarians should take note of this recent FDA Compliance Policy.

For decades the FDA has strictly enforced their idea that drugs are the only cure or treatment for illness – refusing to allow any food to make health or wellness claims. A claim such as ‘An apple a day keeps the doctor away’ is forbidden.

But in the FDA’s infinite collusion with Big Industry, the agency allows pet food the same privilege of a drug (to claim it can cure or treat disease) without any of the requirements of a drug. Pet food is allowed to claim it can cure or treat disease without having to prove the effectiveness or even the safety of the pet food.

Kidney Function Canine Formula Dry/Kibble. This dog food, sold through a veterinarian, is allowed to make the claim of treating kidney disease in dogs.

Ingredients (bold added for emphasis): “Whole grain corn, brewers rice, dried egg product, animal fat preserved with mixed-tocopherols (form of Vitamin E), sugar, dried whey, sodium caseinate, animal digest, calcium carbonate, vegetable oil, potassium chloride, L-Lysine monohydrochloride, fish oil, salt, potassium citrate, choline chloride, zinc sulfate, ferrous sulfate, Vitamin E supplement, niacin, manganese sulfate, Vitamin A supplement, calcium pantothenate, thiamine mononitrate, copper sulfate, riboflavin supplement, Vitamin B-12 supplement, pyridoxine hydrochloride, garlic oil, folic acid, Vitamin D-3 supplement, calcium iodate, biotin, menadione sodium bisulfite complex (source of Vitamin K activity), sodium selenite.”


To read more on this story, click here: Truth About Pet Food

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Thursday, November 12, 2015

Cat Treats Recalled Due to Chemical Contamination


Written by BEA KARNES (Patch Staff)

Blue Buffalo Company has voluntarily recalled Kitty Yums Chicken Recipe Cat Treats because they contain propylene glycol, a solvent not approved for pet food, according to the U.S. Food and Drug Administration (FDA).

The treats were sold in 2 oz., plastic stand up pouches. Only these specific code dates of this product are involved:

Blue Kitty Yums Tasty Chicken Recipe, UPC: 859610007820 - Best If Used By: April 24, 2016.
Blue Kitty Yums Tasty Chicken Recipe, UPC: 859610007820 - Best If Used By: July 24, 2016.
No other pet foods or treats are affected by the recall.

To read more on this story, click here: Cat Treats Recalled Due to Chemical Contamination
  

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Wednesday, May 6, 2015

Bones Are Unsafe No Matter What Their Size: Giving Your Dog a Bone May Make Your Pet a Candidate for a Trip to Your Veterinarian's Office


The stereotypical pairing of a happy dog with a big old bone may soon be history if enough people heed a recent FDA warning about the danger of bones.

The idea of a federal agency warning about something that's been going on for at least 15,000 years, if you consider dogs' predecessors going out and shopping for food in the wild themselves) seemed ludicrous, an affront to one of the oldest associations known to mankind.

If the problems the FDA describes are true, then it's a good idea to educate the public. The agency isn't banning bones. It can't. You buy a hunk of beef, and the bone is yours to do with as you please. The FDA is just warning about them. Here's the exact message:

The idea that it's natural for dogs to chew on bones is a popular one. However, it's a dangerous practice and can cause serious injury to your pet.

"Some people think it's safe to give dogs large bones, like those from a ham or a roast," says Carmela Stamper, D.V.M., a veterinarian in the Center for Veterinary Medicine at the Food and Drug Administration. "Bones are unsafe no matter what their size. Giving your dog a bone may make your pet a candidate for a trip to your veterinarian's office later, possible emergency surgery, or even death."

"Make sure you throw out bones from your own meals in a way that your dog can't get to them," adds Stamper, who suggests taking the trash out right away or putting the bones up high and out of your dog's reach until you have a chance to dispose of them. "And pay attention to where your dog's nose is when you walk him around the neighborhood--steer him away from any objects lying in the grass."

Here are 10 reasons Why It's a Bad Idea to Give Your Dog a Bone:

  • Broken teeth: This may call for expensive veterinary dentistry.
  • Mouth or tongue injuries: These can be very bloody and messy and may require a trip to see your veterinarian.
  • Bone gets looped around your dog's lower jaw: This can be frightening or painful for your dog and potentially costly to you, as it usually means a trip to see your veterinarian.
  • Bone gets stuck in esophagus: The esophagus is the tube that food travels through to reach the stomach. Your dog may gag, trying to bring the bone back up, and will need to see your veterinarian.
  • Bone gets stuck in windpipe: This may happen if your dog accidentally inhales a small enough piece of bone. This is an emergency because your dog will have trouble breathing. Get your pet to your veterinarian immediately!
  • Bone gets stuck in stomach: It went down just fine, but the bone may be too big to pass out of the stomach and into the intestines. Depending on the bone's size, your dog may need surgery or upper gastrointestinal endoscopy, a procedure in which your veterinarian uses a long tube with a built-in camera and grabbing tools to try to remove the stuck bone from the stomach.
  • Bone gets stuck in intestines: This can cause a blockage. It may be time for surgery.
  • Constipation due to bone fragments: Your dog may have a hard time passing the bone fragments because they're very sharp and they scrape the inside of the large intestine or rectum as they move along. This causes severe pain and may require a visit to your veterinarian.
  • Severe bleeding from the rectum: This is very messy and can be dangerous. It's time for a trip to see your veterinarian.
  • Peritonitis: This nasty, difficult-to-treat bacterial infection of the abdomen is caused when bone fragments poke holes in your dog's stomach or intestines. Your dog needs an emergency visit to your veterinarian because peritonitis can kill your dog.
"Talk with your veterinarian about alternatives to giving bones to your dog," says Stamper. "There are many bone-like products made with materials that are safe for dogs to chew on."

"Always supervise your dog with any chew product, especially one your dog hasn't had before," adds Stamper. "And always, if your dog 'just isn't acting right,' call your veterinarian right away!"

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Monday, April 20, 2015

Pain Relief Medications Pill And Creams Proves Toxic And Fatal To Cats


Veterinarians have long warned that pain medications like ibuprofen are toxic to pets. And it now looks like merely using a pain relief cream can put cats at risk.

That's what happened in two households, according to a report issued Friday by the Food and Drug Administration. Two cats in one household developed kidney failure and recovered with attention from a veterinarian. But in a second household, three cats died.

When the veterinarians performed necropsies on the three dead cats, they found toxic levels of nonsteroidal anti-inflammatory drugs, or NSAIDs. NSAIDs include ibuprofen, like Advil and Motrin, and naproxen, which is in Aleve.

Ibuprofen is the most common drug that pets eat, according to the American Veterinary Medical Association, perhaps since many of the pills are candy-coated. In pets, the drugs can cause stomach or intestinal ulcers and kidney failure.

But these cats died by flurbiprofen, another NSAID. In the case of its most recent victims, the cat owner applied a lotion or cream containing flurbiprofen to treat muscle or arthritis pain. And it's highly unusual for a cat to show up at the vet's office; usually it's the dogs that get into trouble from exposure to NSAIDs.

"I can't even remember the last cat I've seen that got into ibuprofen or an NSAID," Erica Reineke, an assistant professor at the University of Pennsylvania's School of Veterinary Medicine, tells Shots. "We've seen more cats that get into antidepressants."

Reineke says that she probably treats a pet for some sort of ingestion problem every day, but usually it's chocolate or chewing gum, or the owner's medication. As little as 50 milligrams of ibuprofen for every kilogram a cat weighs can cause problems; for dogs, it's 100 milligrams for every kilogram. Reineke says she's never seen flurbiprofen toxicity in her office and would have a hard time estimating how much would be toxic to a cat or dog.

This isn't an animal mistreatment issue — none of the cats died because owners were applying their medications to the cats. The owners reported using the product on their necks or feet, and somehow the animals were exposed. The third cat died after the owner had stopped using the medication.

The FDA recommends that pet owners store all medications away from pets and to discard anything used to apply the medication. If any furniture or carpeting becomes contaminated, clean it immediately.

And keep an eye on those pets – if they show signs of lethargy, vomiting or lack of appetite, go see a vet immediately.

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Monday, March 30, 2015

Cat Food Recall: Primal Pet Foods is Voluntarily Recalling a Single Batch Production Code of Feline Turkey Raw Frozen Formula 3-Pound Bag


Primal Pet Foods is voluntarily recalling a single batch production code of Feline Turkey Raw Frozen Formula 3-pound bag. FDA tested product in response to a single consumer complaint. Primal Pet Foods was alerted by FDA that the testing of two bags of this lot resulted in a low thiamine level. Neither FDA nor Primal have received any other reports concerning Thiamine in Primal products. No other product manufactured by Primal Pet Foods is involved in this voluntary recall.

Only the product with the following Best By date and production code is included in the voluntary recall.  It is best to check the production code on the back of the bag to determine if the product has been recalled or not.

The lot involved in this voluntary recall is:

Primal Pet Foods Feline Turkey Raw Frozen Formula 3-pound bag (UPC# 8 50334-00414 0) with Best By date 060815 B22.

Primal takes very seriously, the need for adequate Thiamine levels in our feline diets. We include Organic Quinoa Sprout Powder as a natural B-Complex supplement to ensure that adequate levels of Thiamine are met. Additionally, Thiamine occurs naturally in other ingredients contained in our Feline Turkey Formula such as: Turkey Muscle Meat (including heart), Turkey Liver, Organic Sunflower Seeds, Dried Organic Kelp, Organic Collard Greens and Organic Squash.

Consumers who still have bags of cat food from this lot should stop feeding it to their cats and call at (866) 566-4652 Monday through Friday, 9:00 am – 4:00 pm PST.

Cats fed only diets low in thiamine for several weeks may be at risk for developing a thiamine deficiency. Thiamine is essential for cats. Symptoms of deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. Early signs of thiamine deficiency may include decreased appetite, salivation, vomiting, and weight loss. In advanced cases, neurologic signs can develop, which may include ventriflexion (bending towards the floor) of the neck, wobbly walking, circling, falling, and seizures. If your cat has consumed the recalled lot and has these symptoms, please contact your veterinarian. If treated promptly, thiamine deficiency is typically reversible.

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Tuesday, March 24, 2015

California Family Believes 'Dynamic Pet's Real Ham Bone', Purchased from Walmart, Killed Their Dog


A family from Vista, California, believes that their dog died after eating a Dynamic Pet's Real Ham Bone' that they purchased at Walmart.

It seems that this family is not the only ones full of anger and anguish over Dynamic Pet's Real Ham Bone.

Lily Reed, who is an eighth grader, could not help but break down when talking about the unexpected loss of her furry friend, Fred.

Fred was the family's nine-year-old basset hound, and they had to put him down on Monday.

Lily held onto his toys to feel a little closer.

"I don't know," Lily said through tears. "I just want to remember him."

Fred's owner, Victor Paulson, already misses their guy time.

"He would lay on me and he would love to just lay there in my recliner and just fall asleep," Paulson said.

Paulson still has the bone he believes killed his dog. They bought the Real Ham Bone by Dynamic Pet Products from Walmart. Paulson said they were all in the room when Fred enjoyed it for an hour.

However, the next day was a horrific one.

"There was vomit and diarrhea, and he was lying in a puddle of his own blood," Paulson explained.

Fred was in such bad shape when they took him to California Veterinary Specialists in Carlsbad that the family said their good byes, and put him down.

The veterinarians told 10News they did not have a definitive answer about what made Fred ill because the family could not afford to run the tests.

The family seems certain the bone broke apart and ripped apart Fred's insides.

"It couldn't have been anything else," Lily said. "It just couldn't have."

The warning on the Real Ham Bone is more detailed than most. It says:
"Supervise your pet while enjoying any natural bone product. Bone is to be chewed over several sittings, not eaten. Always provide a fresh supply of water to pet. Not recommended for dogs with digestive problems or aggressive chewers. Remove bone immediately if splintering occurs or small fragments break off. Recommended size is slightly larger than your pets mouth. Pet owner assumes liability associated with the use of this or any natural bone product."

10News found dozens, if not hundreds, of comments online with a similar story. Owners gave their dog a ham bone, often the same brand, and the dog started vomiting. Some dogs had surgery, while others died, according to some of the online comments.

10News reached out to Dynamic Pet Products, and they issued this statement:
ST. LOUIS, March 4, 2015 – Dave Frick, President, Dynamic Pet Products, released the following statement today in response to the complaint filed by a consumer regarding Real Ham Bone for Dogs.

"At Dynamic Pet Products, our goal is to offer the best pet products to owners and their dogs. We are saddened to learn of the illness of any of our customers' pets.

Dynamic Pet Products has been producing 100% Human food grade bones approved by the FDA since 2001, including the Real Ham Bone for Dogs. The quality of our products and the safety of the pets that enjoy our products are our top priorities. That is why every package contains a label that provides detailed instructions to owners on how they can help their pets best enjoy our products. We strongly encourage owners to supervise their pets with any treats or snacks. We will continue to provide quality, safe products to our customers."

On a Consumer Affairs web page, the product ranked one of five stars.

The Food and Drug Administration says bones are unsafe across the board. They say problems range from broken teeth to blocking the windpipe, and bone chards can poke holes in the stomach or intestines.

Giving your dog a bone can result in a vet visit, surgery or death. Read more here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm208365.htm

Walmart told 10News: "We did reach out to the manufacturer and they are aware of this situation and had been in touch with the customer."







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Monday, March 16, 2015

Two Senators Are Urging the Food & Drug Administration to Open an Investigation into the Purina’s Beneful Brand Dog Food Allegations


A lawsuit filed in California claimed that thousands of dogs became ill or died after eating Purina’s Beneful kibble. Two senators are urging the Food & Drug Administration to open an investigation into the allegations.

Illinois Senator Dick Durbin, along with California Senator Dianne Feinstein, sent a letter [PDF] to the FDA calling for the agency to quickly investigate claims that Purina PetCare Company’s Beneful brand dry dog food contains toxins.

The senators also called for immediate updates on the implementation of FDA
requirements that could prevent such harmful contamination from occurring in pet foods.

In late February, it was revealed that a California man had filed a class action-seeking lawsuit against Purina saying the company’s dry dog food contains substances that are known to be toxic to animals and can lead to internal bleeding and other serious health issues for pets.

The man alleges that less than a month after beginning to exclusively feed his dogs Beneful dry kibble, all three became ill and his 8-year-old English Bulldog eventually died.

According to the lawsuit, illnesses experienced by thousands of dogs across the country were a result of toxins in Beneful such as, but not limited to, Propylene glycol and Mycotoxins.

Propylene glycol, the lawsuit states, is an automotive antifreeze component that is a known animal toxin. However, the substance is also an FDA-approved food additive for humans.

As for Mycotoxins, the lawsuit states they are a group of toxins produced by fungus that occurs in grains.

Representatives for Purina have said that the lawsuit was “without merit” and that the company would vigorously defend itself.

In their letter to the FDA, Durbin and Feinstein are asking for updates to the agency’s implementation of a 2007 law enacted to help prevent contaminated pet food from reaching animals.

Under the 2007 law, the FDA is required to ensure that pet food companies report to the agency within 24 hours of determining they have an adulterated product in their supply chain.

Additionally, the law requires the FDA to set ingredient and processing standards for pet food, strengthen labeling requirements, establish early warning systems for contaminated products and mandate that companies report contaminated food and make key records available during investigations.

“The components of the law that FDA has implemented are important to the public and veterinarians, namely the searchable online recall list posted on the agency’s website,” the letter states. “We appreciate that FDA has implemented an online database to inform consumers of pet food recalls. However, eight years later, most provisions of the pet food safety law have not been implemented and protections Congress enacted are not in place.” FOLLOW US!
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Monday, January 19, 2015

The FDA Issued a Warning Letter to a Purina Pet Food Canning Facility Finding 'Significant Deviations' from Pet Food Regulations


The FDA issued a Warning Letter to a Purina Pet Food canning facility finding 'significant deviations' from pet food regulations. Though no recalls have been issued, FDA had serious concerns about this pet food plant.

The FDA Warning Letter stated their inspection lasted for two weeks – from September 15, 2014 through October 1, 2014. Inspection revealed “that your facility has significant deviations from the LACF (low-acid can food) regulations.”

The inspection found that this Purina plant deviated from the required processing of the pet food – and further did not document the deviation (as required by law). The FDA Warning Letter stated “your firm did not provide documentation associated with the evaluation of the entire lot of product affected by the process deviation and did not provide documentation and/or the specifics of your corrective action plan in order to ensure that your firm will prevent these occurrences in the future.”

FDA also found temperature drop concerns with the pet food manufactured at this plant. Law requires canned pet food to be heated to specific temperatures and any variations of these required temperatures are required to be noted in a log. This Purina plant did not document the drop in temperatures.

FDA “observed” that the conveyor system in this plant did “not have adequate protection in place to prevent an unprocessed can” from ultimately reaching the consumer. An ‘unprocessed can’ of pet food would be an uncooked can of pet food – uncooked can of feed grade ingredients that could be full of dangerous bacteria. Purina responded to FDA they are in the process of correcting this issue, however FDA stated “We do not consider this response acceptable because you did not provide specifics of your corrective action plan in order to INSURE that your firm will prevent these occurrences in the future.”

The public FDA Warning Letter to Purina  – posted on the FDA website – does not provide lot numbers of products involved. The only information consumers have is product names – listed below. All of these products are canned/moist foods.

Alpo PRIME Cuts with Beef
Alpo Chop House Originals Filet Mignon
Alpo Chop House Originals roasted Chicken
Friskies Mariner’s Catch
Friskies Mixed Grill
Friskies Gravy Sensations with Turkey and Giblets
Friskies Supreme Supper
Friskies Indoor Chicken
Friskies Salmon Dinner
Mighty Dog Chicken Egg & Bacon Country Platter
Mighty Dog Chop House Originals Filet Mignon
Mighty Dog Lamb and Rice
ProPlan Senior Beef and Rice Entrée

If you are feeding your pet one of these products – please pay close attention to your pet’s health. Should any illness occur, notify your veterinarian first, the FDA second.

You can report a pet illness to the FDA here: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htm


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Wednesday, November 5, 2014

It Shall Be Suitable For Use In Animal Food


“It shall be suitable for use in animal food.” These nine little words are found in numerous places within pet food regulations, but they are not found within federal food law. These nine little words allow a multi-billion dollar a year industry to mislead pet food consumers. What – exactly – do these nine little words mean?

To read more on this story, click here: It Shall Be Suitable For Use In Animal Food











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Wednesday, August 13, 2014

Owners, Vets Reporting Even More Deaths Suspected to be Connected to Trifexis


Channel 2 consumer investigator Jim Strickland has discovered that hundreds more pet deaths are now blamed on a popular dog medicine.
       
Since Strickland first reported data collected by the Food and Drug Administration eight months ago, the number of death complaints is up nearly 40 percent, now coming in at a rate greater than one dog per day.
       
The FDA cautions there is no solid evidence linking Trifexis to any dog's death.  The reports are simply complaints from owners and vets in which the pill is suspected.
       
"It's just horrendous to watch an animal die such a horrible, painful, excruciating death," said Acworth resident Anita Bergen.

Bergen's case is included in the FDA data.

Her Scottie named Fergus was 10 years old when she tried Trifexis.
       
"The initial reaction from taking that one pill was horrible," Bergen said.
       
"One pill?" asked Strickland.
       
"One Trifexis pill was all he ever had."
       
Bergen says the dog lost all muscle control, lost his thirst and suffered liver failure.  She euthanized him two months after giving him the pill.
       
"I do feel deceived. I do not feel there was full disclosure," Bergen said.
       
Trifexis is a once-a-month pill to kill fleas, control parasites and prevent heartworm. TV commercials list side effects like vomiting and lethargy, but not death.
       
Strickland learned through the Freedom of Information Act that the FDA lists 965 complaints of dog deaths blamed on Trifexis.

That's an increase of 38 percent in the last eight months, and close to the total of 1,000 deaths linked to Chinese-made chicken jerky pet treats.
       
Drug maker Elanco maintains it can find no link between the pill and any dog fatalities.
         
"I see that as a cause for investigation, and as they're looking at those causes. I feel confident the FDA will follow through, but from our experience, we haven't seen it," said Cobb County veterinarian Toby Carmichael.
       
Carmichael says he and his partners have prescribed 75,000 doses of Trifexis with no adverse complications.
       
"My dogs have been on Trifexis since it came out and haven't had an issue once,” Carmichael said.

Physician Rochelle LePor has given her 7-year-old rescue dog Cooper nearly 40 pills over three years.
       
"I can only speak of my experience. For me, it’s like a wonder drug," she said.
       
"The FDA is not going to allow a product on the market that's going to hurt animals," added Carmichael.
       
Reports to Elanco's customer hotline have had an impact. There are now nearly 1,500 complaints of lost muscle control; a condition called ataxia.

Elanco added ataxia to its list of side effects two years ago.
       
Elanco also added seizures, the malady that hit a prize bulldog named Foxy, owned by 50-year veteran breeder Nancy Harrison.

The dog developed additional symptoms beyond her veterinarian's control.
       
"So you were forced to euthanize her?" Strickland asked.
       
"Yeah, if you saw it, you wouldn't want to live with it either. And never in 52 years had I had one before,” Harrison said.
       
Harrison stopped using the drug, even though her other dogs handled it without issue.
       
"It's hard to lose a dog. They're my children," said Harrison.

The mystery of their dogs’ deaths eats at her and Bergen.
       
"All the tests that are done, they're all inconclusive.  No one can ever say this death is absolutely the result of administering this particular medication. But all the owners, all the pet caregivers know," said Bergen.
       
The FDA says it's continuing to monitor reports, and considers the product label a living document.  To date, there are no plans to list death as even a rare but potential side effect.



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What You Should Know About Online Pet Medication Scams


What you don’t know about the Internet could make your dog sick and you broke.

Last year, Americans spent nearly $56 billion on their pets — an all-time high — and are expected to spend $60 billion this year . Plenty of that went to veterinary care, which includes prescription medication, as well as over-the-counter meds. In aggregate, Americans spend more than $14 billion a year at the vet and more than $13 billion on supplies and over-the-counter medication. This means that some pet owners must shell out hundreds, even thousands, for medications for their pets each year.

Thanks in part to these high costs, more pet owners are turning online for their pet’s medication. “Consumers realize that pets often require medicine that is absurdly expensive when compared to the human drug equivalent, because of the veterinary markup over wholesale and dispensing fees charged at many vet offices,” says Laura Nativo, pet expert from Hallmark Channel’s “Home & Family” show. “With the growing number of Internet pharmacies, savvy pet parents realize that shopping online can amount to lower prices, added convenience.”

But that convenience and cost savings can come with a serious downside: the risk of scams. SiteJabber , a website where customers can review online businesses, has seen a 60% year-over-year increase in the number of consumer complaints over businesses selling pet medications online. “It’s one of the fastest-growing areas of complaints on the site,” says Jeremy Gin, the founder of SiteJabber.

SiteJabber analyzed more than 1,000 consumer complaints about online pet medication companies to determine the most-complained about issues. Here are three.

1. Automatic shipments that won’t stop (and you keep paying for)

More than 15% of the customer complaints about online pet medication businesses involved auto-shipments, according to the SiteJabber analysis. Here’s what often happens: A pet owner sets up an auto-shipment of certain medications because her pet has a recurring condition that needs regular medication. But when she tries to cancel the auto-shipments, she finds it nearly impossible to do so — and keeps getting charged for medications she no longer needs.

What consumers can do: Gin recommends that right after consumers call the pet med company to cancel auto-payment of their medications, they also call their credit card company to let them know that they should not authorize any more automatic payments from that company.

2. Shipments that take forever — or never come

One in five pet owners who bought pet medication online complained about pet medication shipments that took far longer than promised or never even came, the SiteJabber data revealed. This may be a particularly acute problem if you order from a company based abroad, as customs may be an issue, he says.

Not only is this annoying, but it can be harmful to your pet’s health if they aren’t getting the medication they need.

What consumers can do: Have a backup pharmacy in town that you know will have the medication (call to make sure they have it in stock) — even if it will cost more, says Gin. That’s because even if you call the company to confirm the delivery date of your medication — or even if they have a guaranteed delivery date — the company may still not get it to you on time. To try to get your money back if they don’t deliver when promised, request it both in writing and verbally; that may not work though, in which case, you may have to go through your credit card company, says Gin.

3. Fake pharmacies that send fake medications

“Many online pharmacies are not safe,” says Amber Anderson, a veterinarian based in Rancho Palos Verdes, Calif.; and indeed, of the 420 online pet pharmacies reviewed on SiteJabber, more than one in three were identified as non-legitimate pharmacies, meaning that they likely violated laws or regulations around the sale of drugs. These pharmacies may give you medication that isn’t what you asked for (and thus does not help your pet), sugar pills or other fake pills, diluted versions of the medication, medication with additives that may be bad for your pet, and more.

What consumers can do: Consumers need to verify that the pharmacy they are using is legitimate, and because there are so many that aren’t, this isn’t an easy process. The FDA recommends that you only order from a website that is designated Vet-VIPPS, which stands for the Veterinary-Verified Internet Pharmacy Practice Sites; this is given by the National Association of Boards of Pharmacy to online pet med pharmacies who comply with NABP’s criteria, including licensing and inspection requirements, quality and validity of prescription orders. Gin says that you should make sure the site is verified by LegitScripts.com, and Nativo recommends looking at online TopConsumerReviews.com as well as searching for the company online and through social media to see what other customers are saying.

Steve McFarland, the president and CEO of the Better Business Bureau of Los Angeles and Silicon Valley, says that you should also ask your vet how to get less expensive medication that is safe or ask friends for referrals. And Nativo says she likes sites like PetCareRx.com , DrsFosterSmith.com and even Costco.com .

Finally, “many online pharmacies touting too-good-to-be true advertising such as ‘Discount pet drugs! No RX required!’ are not regulated, but may seem legitimate, which causes unfair confusion for consumers,” says Nativo. “Remember, if it’s too good to be true, it probably is — and saving money is not worth potentially short changing your pet’s wellness.”

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Tuesday, May 20, 2014

Dog Owners Please Read! Jerky Treats Lead to 4,800 Complaints, Including Over 1,000 Dead Dogs and 3 People Who Fell Ill


The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are teaming up to investigate over 1,000 dog deaths and three people who fell ill after consuming  chicken, duck and sweet potato pet jerky imported from China. Following the FDA’s last update back on October 22, 2013, 4,800 complaints of illness, some including multiple pets in one household, have been reported to the agency involving 5,600 dogs, 24 cats and three people.

According to the FDA’s latest report, around 60 percent of the cases were tied to gastrointestinal and liver disease, 30 percent kidney or urinary disease, and 10 percent that included neurologic, dermatologic, and immunologic symptoms. Approximately, 15 percent of kidney and urinary cases also tested positive for Fanconi syndrome, a rare kidney disease tied to reported cases of pet and human illnesses. The FDA has still been unable to identify an exact cause for the sudden outbreak.

The FDA and CDC are collaborating on a study tracking food consumed by sick dogs reported to the agency compared to what healthy dogs ate. Researchers hope the analysis will be able to tell what type of food (human or pet food) is making pets and people sick. The FDA has already performed 26 post mortem examinations on 26 dogs reported to the agency since October 2013. It was discovered that 13 of these dogs had consumed pet jerky and 11 showed signs of kidney disease while two were identified with gastrointestinal disease.

“The agency continues to review case records, test treat samples from reported cases, screen tissue, blood, urinary and fecal samples, and communicate with the attending veterinarians and pet owners to thoroughly investigate select cases,” the FDA said in a statement. “Because of the volume of information received in response to the Dear Veterinarian letter, the agency has not completed an update to our online case spreadsheets. FDA plans to complete and post these updates in the coming months.”

Of the three humans who fell ill as a result of consuming pet jerky, two were toddlers who ingested it accidently and one adult who was snacking on the pet treat for unknown reasons, NBC News reported. One of the toddlers was diagnosed with a salmonella infection and the other suffered from a gastrointestinal illness and fever, similar to the symptoms experienced by dogs in the same household. The adult reportedly suffered from symptoms including nausea and headache.

“Testing of jerky pet treats from China has also revealed the presence of the drug amantadine in some samples containing chicken,” the FDA added. “These samples were from jerky pet treats that were sold a year or more ago. Amantadine is an antiviral that is FDA-approved for use in people. It has also been used in an extra-label manner (using an approved drug in a way that isn’t listed on the label) in dogs for pain control, but FDA prohibited its use in poultry in 2006.”





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Wednesday, October 23, 2013

Check Your Pet Treats - Mysterious Outbreak of Illnesses Tied to Jerky Treats Made in China - 600 Pets Have Died and More Than 3,600 Have Been Sickened


Nearly 600 pets have died and more than 3,600 have been sickened in an ongoing, mysterious outbreak of illnesses tied to jerky treats made in China, federal animal health officials said Tuesday.

Most of the cases have been in dogs of all breeds, ages and sizes — although 10 cats have been sickened, too — after eating chicken, duck and sweet potato jerky treats. The pace of the reported illnesses appears to have slowed, but federal Food and Drug Administration officials are now seeking extra help from veterinarians and pet owners in solving the ongoing puzzle.

“To date, testing for contaminants in jerky treats has not revealed a cause for the illnesses,” Martine Hartogensis, a deputy director for the FDA’s Center for Veterinary Medicine, said in the new report. “Despite these warnings, we have continued to receive reports of illnesses in both cats and dogs.”

The new numbers are up from some 500 deaths and 3,200 illnesses tallied in January, but the rate of reports has fallen sharply since then, mostly because two of the largest sellers of pet jerky treats announced recalls    tied to the presence of unapproved antibiotic residue detected in the products.

FDA officials don’t think that antibiotic residue is the big problem that has stumped the agency since 2007, when pet owners started reporting their animals were suffering gastrointestinal and kidney problems after eating the popular jerky treats.

Instead, it’s likely that the recall of Nestle Purina PetCare Co.’s Waggin Train and Canyon Creek Ranch treats, plus Del Monte Corp.’s Milo’s Kitchen Chicken Jerky and Chicken Grillers home-style dog treats simply resulted in fewer treats being available. Three other smaller retailers also recalled the treats because of the problem.

In fact, FDA officials remain as uncertain as ever about the source of the problem that has led to reports of illnesses and warnings about the possibility of Fanconi syndrome and other kidney problems in animals that ate jerky treats.

“We still are extensively testing treats for a number of things,” Hartogensis told NBC News. “We do seem to be getting some leads, but we still have a little bit of a ways to go.”

Kendal Harr, a veterinary clinical pathologist who has been tracking the problem, says that the specific compound responsible for the illnesses continues to elude experts.

"I think that what it tells us is that the intoxicant is something that we're not used to dealing with as a toxin in North America," she said.

Now, in an open letter to US veterinarians, FDA officials are asking the vets to track and send detailed information about any animals sickened by jerky treats, including results of blood and urine tests. In addition, the agency is asking vets to send urine samples from suspect pets for analysis.

“This testing will allow FDA to get a better idea of how many of the suspected cases involve Fanconi syndrome, whether or not the pets display symptoms of kidney or urinary disease,” the report said.

About 60 percent of reports cite gastrointestinal illness in the animals, and about 30 percent flag kidney or urinary troubles, the report said. About 135 cases of Fanconi syndrome, a specific kind of kidney disease, have been reported.

At the same time that they’re seeking help from vets, FDA officials are putting out a fact sheet for owners that can be posted at veterinary hospitals, pet supply stores and other sites.

The agency has repeatedly cautioned that the treats are not necessary for a balanced diet, but the warnings stop short of a recall, Hartogensis said. The agency is still validating tests to detect the same kind of antibiotic residue that New York officials found earlier this year.

“If we do find an adulterated product, we will recall them,” Hartogensis said. “In terms of doing a blanket recall, at this point we don’t have enough evidence to do a blanket recall within the authority that we have.”

Because there's no formal recall, it's not possible to list affected brands, although a previous FDA analysis indicated that three of the top-selling brands of jerky treats sold in the U.S. were mentioned in connection with pet illnesses.

That doesn't sit well with pet owners like Robin Pierre of Pine Bush, N.Y., who contends that Waggin' Train chicken jerky treats were responsible for the sudden death in 2011 of her previously healthy 2-year-old pug, Bella, who developed kidney failure. She has long called for FDA to crack down on treat makers — and manufacturers.

"I am disgusted that our government continues to protect corporate American and China," she told NBC News. "They need to start protecting the American consumer so that this does not happen again. As soon as a product is in doubt, a warning label should be placed at the point of sale so that consumers can make an educated choice."

If a pet does become ill after eating the treats, FDA is asking owners to provide detailed information — up to and including results of a necropsy to test an animal’s tissues after death.

In the meantime, officials are trying to reach pet owners who might still have treats on hand to make sure they know about the potential problems.

“Right now, the focus for us is to make the public aware that these cases are still coming in,” she said.


Toby, a 6-year-old Boston terrier, died in 2012 after his owners say he was sickened by chicken jerky pet treats made in China.



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Wednesday, May 23, 2012

If You Have a Dog, Please Read - Chinese Pet Treats Linked to 900 Dog Deaths, Illnesses



Just six months after issuing its latest warning about chicken jerky dog treats made in China, the Food and Drug Administration confirms it has logged more than 900 complaints from pet owners who say their dogs either were sickened or died after eating the treats.

The number of complaints has nearly doubled since the story was first reported by ABC News in March. The FDA says its investigation is ongoing and that it continues to test samples of the popular treats, which dog owners across the country say have caused kidney failure in their pets, resulting in severe illness or death.

Consumers have largely blamed two brands for the reported illnesses. Waggin' Train and Canyon Creek Ranch, both produced by Nestle Purina and made in China, are reportedly included in the samples being tested by the FDA. The agency told ABC News it has solicited samples of treats from the owners of the pets allegedly affected, but will not say whether it is tested those samples. To date, the FDA has not been able to determine a cause for the reported illnesses.

The FDA issued its first warning about chicken jerky treats from China in 2007 and again in 2008, both times based on consumer complaints. But it wasn't until a third warning -- in late 2011 -- that the momentum of complaints accelerated as an angry population of pet owners demanded to know what in the Chinese treats might be sickening their dogs.

"It's hard to believe that we're still fighting the same battle," said Terry Safranek, whose 9-year old Fox Terrier named Sampson died of kidney failure in January.

"The last thing that he ate and then threw up was the chicken jerky," said Safranek. "It kills me that the treats I fed him killed him."

Safranek is a member of a Facebook group called "Animal Parents Against Pet Treats Made In China," which has grown to 4,500 members and includes hundreds of photos of dogs whose owners claim were sickened or died from chicken jerky treats.

"We're just the ones who are online. There literally could be tens of thousands of people whose dogs were affected," said Safranek.

The group also keeps its own spreadsheet of victims, ranging from a 1-year old, five-pound Chihuahua named Kiarra to a 111-pound German Shepherd named Floyd.

"The problem with the issue is getting the word out," said Dr. Richard Goldstein, Chief of Medicine at The Animal Medical Center in New York City. Goldstein has been studying the connection between pet illnesses and chicken jerky treats made in China since 2007 and says although deaths have been rare in his experience, it's still crucial to seek veterinary care if a dog shows symptoms such as vomiting or lethargy.

"These are still on the shelves and cases are still popping up," said Goldstein, urging pet owners to be vigilant.

The issue has gained attention in Washington, and Sen. Sherrod Brown, D.-Ohio, who has been urging Congress to look closely at products coming from China, recently blasted the head of the FDA over the issue. At a Senate Appropriations hearing in April, Brown told Dr. Margaret Hamburg he was concerned that pet owners were still buying the treats, unaware they may possibly be tainted. "The FDA must be as aggressive as possible to find the source of this contamination," he said later in a press release.

A spokesperson for Nestle Purina told ABC News in March that the safety of pets is the company's utmost priority and that production of the treats in China is held to the highest quality and safety standards. Nestle Purina has not been named in any of the FDA warnings and the company points out that reported illnesses may be the result of eating things other than the chicken treats. "We've looked at this, and we continue to look at this," Keith Schopp told ABC News.

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Friday, May 4, 2012

If You Have a Dog - PLEASE READ - Multiple Diamond Dog Foods Now Linked to Salmonella Outbreak in Humans



It now appears multiple Diamond Dog Food products have been linked to salmonella infections in the human population.

In a bulletin dated May 3, 2012, the Centers for Disease Control (CDC) has announced the agency is collaborating with public health officials in multiple states along with the Food and Drug Administration (FDA) investigate an ongoing multistate outbreak of human Salmonella Infantis infections.
According to the report.

Public health investigators used DNA “fingerprints” of Salmonella bacteria obtained through diagnostic testing with pulsed-field gel electrophoresis, or PFGE, to identify cases of illness that may be part of this outbreak. They used data from PulseNet, the national subtyping network made up of state and local public health laboratories and federal food regulatory laboratories that performs molecular surveillance of foodborne infections. The outbreak strain is rare and typically 0-3 isolates are reported per month.

Multiple brands of dry pet food produced by Diamond Pet Foods at a single manufacturing facility in South Carolina have been linked to some of the human Salmonella infections. People who think they might have become ill after contact with dry pet food or with an animal that has eaten dry pet food should consult their health care providers.

So far, among the 14 individuals reported having the infection, five were hospitalized — and no deaths have been reported.

Public health investigations are ongoing to determine if other brands of dry dog food produced at the South Carolina facility are also contaminated with Salmonella – and possibly linked to human illnesses.

The Bottom Line
What’s especially troubling about this story is that the illnesses date back to October 8, 2011 – almost 7 months ago.

This fact alone makes the health complaints reported by many of our readers under some of the Diamond product reviews on this website more noteworthy. For this reason, we’re now becoming increasingly suspicious of the actual extent of Diamond’s Salmonella contamination issue.

And so, we must recommend special caution if you’re feeding any product manufactured by Diamond at its South Carolina plant.

Unfortunately, it’s still unclear which products are produced at that location. So, without more information from Diamond Pet Foods or the FDA, it’s impossible for anyone to reliably predict if – or when – another recall may materialize.

What to Do
I can’t stress enough how important it is to check the Diamond Pet Foods Recall website for exact products, images and production codes associated with the recall.


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