Tag: FDA

FDA Warns About Accidental Overdose Risk of Noise Aversion Drug Sileo

The Fourth of July is no holiday for many dogs who are terrified by the sound of fireworks. If you plan on giving your dog the noise aversion drug Sileo, please take heed of the U.S. Food and Drug Administration’s continued warning to avoid an accidental overdose.

Since the prescription gel Sileo was introduced just two years ago, the FDA has received 54 adverse event reports from dog owners. The problem is that Sileo is packaged in an oral dosing syringe with a ring-stop mechanism on the plunger that must be turned and locked into place to set the correct dose — and the ring-stop mechanism does not always lock, causing an overdose.

Last year the FDA advised Sileo’s manufacturer, Zoetis, to improve the product’s labeling to emphasize the need to secure the ring-stop mechanism. Zoetis changed the labeling and added videos on its website that show how to properly administer Sileo.

Yet the FDA reissued an advisory today about Sileo “because adverse events are continuing to occur,” it stated. “The agency continues to advise veterinarians to carefully educate owners and handlers how to properly use the syringe to avoid accidental overdosing.”

Fortunately, no dogs have died — yet. But some have experienced the clinical signs of an overdose, which include loss of consciousness, trouble breathing, impaired balance, muscle tremors, slow heart rate, low blood pressure and lethargy. The FDA says it has not determined whether the overdoses were caused by improper use of the ring-stop mechanism.

If you still want to give your dog Sileo, make sure your veterinarian shows you exactly how to use the syringe. Be sure to keep an eye on your dog for any of the above symptoms of an overdose, and and immediately contact your vet or an emergency animal hospital if your dog shows any of these signs.

Noise Aversion without Drugs

My dogs Leroy and Ella luckily have no fear of fireworks, but that wasn’t the case years ago with my dogs Larry and Sophie. Once, and only once, I gave them a sedative prescribed by their veterinarian to help relax them on the Fourth of July. They did sleep through most of the noise, but then I read that tranquilizers don’t actually help relieve the anxiety of dogs and cats. In fact, drugs like acepromazine are like a “chemical straitjacket,” according to Dr. James Nicholas.

“This is because acepromazine does little to nothing to help mitigate the fear and anxiety that these suffering pets experience from fireworks and thunderstorms,” Dr. Nicholas wrote. “What it does do though, and do well, is make them unable to move and/or exhibit any of the other outward signs of their fear and anxiety.”

The following Fourth of July, I created a “safe room” in the bathroom, with their beds, toys and a radio loudly playing classical music. Larry and Sophie were still a little agitated, but much less so than in previous years. Even after the holiday, the dogs would instinctively run into the bathroom when they heard a firecracker or other loud noise. One time I had the radio on while cleaning the house, and the dogs suddenly retreated to their safe room. Why? The song “You Dropped a Bomb on Me” by the Gap Band, which includes fireworks sound effects, was playing!

If you want your dog to have a safe and sane Fourth of July without drugs, here are some helpful tips I’ve compiled from American Humane and Humane Society of the United States.

Do:

  • Bring your dog inside your home.
  • Play loud music, or turn up the volume on the TV or radio.
  • Create a “safe area” in a bathroom or other quiet, escape-proof spot, filled with blankets and your dog’s favorite toys.
  • If possible, have someone stay with your dog if you’re going to a fireworks display or party.

Don’t:

  • Coddle your dog by saying something like, “It’s okay” or “Poor baby!” Just act naturally and go about your business as usual.
  • Take your dog to fireworks displays. (Duh.)

Photo: anneheathen

 

 

FDA Finally Adds Pet Food Manufacturing Requirements

For the first time ever, the U.S. Food and Drug Administration (FDA) announced today it is establishing requirements for the current good manufacturing practice (CGMP) for food for animals.

“In addition, we are adding requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals,” the FDA stated.

It’s about time.

After thousands of dogs and cats in the United States died eight years ago as a result of eating contaminated pet food, Congress passed the FDA Amendments Act of 2007. It requires improved regulations for pet food safety, including stronger labeling requirements, an early warning system for tainted food, and establishing standards for ingredients and manufacturing.

“However, eight years later, most provisions of the pet food safety law have not been implemented and protections Congress enacted are not in place,” wrote U.S. Senators Dianne Feinstein and Dick Durbin in a letter to FDA Commissioner Margaret Hamburg in March.

The senators were requesting an FDA investigation into the class-action lawsuit filed in February claiming that thousands of dogs were sickened or died after eating Beneful dry kibble.

“To our knowledge, the FDA has not issued any investigations, warnings, consumer guidance or product recalls to address these alarming issues,” the senators wrote.

Regarding its new CGMP requirements, which go into effect Nov. 16, the FDA stated, “We are taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals, and to implement new statutory provisions in the FDA Food Safety Modernization Act (FSMA).

“The rule is intended to build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.”

The Preventive Controls for Animal Food Rule is one of two rules finalized today that will implement the FSMA. The other is the Preventive Controls for Human Food Rule, which will create new safety requirements for facilities that process, package and store food for human consumption.

Photo credit: Tony Alter

Beware of Deadly ‘Real Ham Bone’ Dog Treats

More than six dogs have died and hundreds have gotten sick after eating Real Ham Bone treats, sold by Walmart and other stores.

After receiving hundreds of complaints from pet parents over the past five years, the Better Business Bureau (BBB) has contacted U.S. senators, asking them to order Dynamic Pet Products of Washington, Mo., to stop manufacturing the harmful treats.

A class action lawsuit against the manufacturer was filed last month by Khristie Reed, whose Basset Hound, Fred, died after eating a Real Ham Bone.

David Frick, president of Dynamic Pet Products, has refused interview requests from the media.

“At Dynamic Pet Products, we are taking seriously the concerns people have raised,” the company said in a statement sent to FOX6. “We have millions of customers who want a natural bone for their pets and safely use this product with a high level of satisfaction.”

According to the company website, a Real Ham Bone “is the actual femur bone from a hog that has been seasoned and smoked with hickory wood. This is a natural bone, made in the USA. We adhere to strict quality regulations in our plants.”

Tracy Hardgrove, vice president of the BBB in St. Louis, told KSDK that because the bones are smoked, they are especially brittle and likely to splinter inside a dog’s gastrointestinal tract.

That’s exactly what happened to Dave Marklein’s dog, Gunner, after he ate a Real Ham Bone.

“In the middle of the night he had diarrhea and bloody diarrhea — he was almost dead,” Marklein told KSDK. A veterinarian told him the bone had splintered in Gunner’s stomach, blocking his colon.

A few hours after Lisa Nickerson of Onset, Mass., gave her dog, Nala, a Real Ham Bone, Nala became violently ill and was sick for a week.

“Every day I thought I was going to lose her,” Nickerson told CBS Boston. “I was crying every day. I missed work. It was awful.”

Reed, who filed the class action lawsuit against Dynamic Pet Products after her dog died, also started a Change.org petition urging the company to take Real Ham Bones off the market. The petition currently has more than 14,000 signatures.

Reed also started the Facebook group, “Fight for Fred…Ban products that are unsafe for dogs to consume.”

The morning after Fred ingested part of a Real Ham Bone, he was vomiting, having diarrhea and bleeding from his rectum. He was rushed to an animal hospital and placed in intensive care. Unfortunately, the veterinarian recommended that Fred be euthanized.

“I am never going to forgive myself for buying him that deadly treat,” Reed wrote on Change.org.

No Bone Is Safe for Dogs

On its website, the U.S. Food and Drug Administration (FDA) advises pet parents not to give their dogs any bones, and to always supervise your dog with any chew toy, especially one your dog hasn’t had before.

The Real Ham Bone label warns that it’s “to be chewed over several sittings, not eaten…remove bone immediately if splintering occurs or small fragments break off.”

However, it’s difficult to stop most dogs from swallowing the treat, as Ron Witt, whose dog, Panda, became seriously ill after eating it, told FOX6.

He said it was similar to telling a human to “go to your favorite restaurant and only just smell your wonderful dinner — don’t consume that.”

The BBB’s Hardgrove told KSDK, “Some of these dogs have suffered horribly, some have died and they are family members.” She said that since only about 5 percent of people file complaints with the BBB, many other dogs may have been sickened or died after eating Real Ham Bones.

Missouri Senator Clair McCaskill has contacted the FDA to see what action it’s taking regarding the harmful treats.

“I don’t need to be convinced a product killing families pets needs to be looked into,” she told KSDK. “Their mandate is to look at whether a pet product is safe and we’ll hold their feet to the fire.”

Some retailers have removed Real Ham Bones from their shelves. Walmart, however, continues to sell them.

“At Walmart, we are committed to providing our customers and their pets with safe, quality pet treats,” the company wrote in a statement to FOX6. “We are saddened to learn of this report of illness alleged to be associated with this product and we are working with the supplier to promptly investigate it. If you have additional questions, we recommend you contact the supplier directly at 636-266-9814.”

Buyer beware.

If your dog has been sickened or worse after eating a Real Ham Bone, please file a complaint with the BBB and your senator, and submit a report to the FDA’s Safety Reporting Portal.

Photos via Fight for Fred… Facebook page

US Senators Want FDA to Investigate Beneful-Related Dog Deaths and Illnesses

In response to the class-action lawsuit filed last month claiming that thousands of dogs were sickened or died after eating Beneful dry kibble, U.S. Senators Dianne Feinstein and Dick Durbin sent a letter to U.S. Food and Drug Administration Commissioner Margaret Hamburg earlier this week.

They asked Hamburg to have the FDA investigate the claim and provide updates about measures being taken to prevent contamination of pet food.

“To our knowledge, the FDA has not issued any investigations, warnings, consumer guidance or product recalls to address these alarming issues,” the senators wrote.

After thousands of dogs and cats died eight years ago as a result of eating contaminated pet food, Congress passed the FDA Amendments Act of 2007. It requires improved regulations for pet food safety, including stronger labeling requirements, an early warning system for tainted food, and establishing standards for ingredients and manufacturing.

“However, eight years later, most provisions of the pet food safety law have not been implemented and protections Congress enacted are not in place, amid allegations of contaminated Beneful dry kibble,” the senators wrote.

“To put it frankly, the food safety system Congress fought to develop has not been put in place by the FDA.”

Beneful Contains Automotive Antifreeze Ingredient

Frank Lucido, who filed the suit against the Nestlé Purina Petcare Company in a California federal court, said he began feeding his three dogs Beneful dry dog food in December. Within a month, all three began suffering stomach and liver problems. His English Bulldog died on Jan. 23 due to internal bleeding and lesions on his liver. His other two dogs, a German Shepherd and Labrador, are showing similar symptoms.

These were far from being isolated cases. According to the lawsuit, there are thousands of complaints on the internet (including several hundred on ConsumerAffairs.com) “about dogs becoming ill, in many cases very seriously ill, and/or dying after eating Beneful.”

All of these dogs had the same symptoms: vomiting and liver problems.

The suit says the food’s main ingredient, propylene glycol — which is also a component of automotive antifreeze — is toxic to dogs. This ingredient apparently helps keep the kibble moist, but it has lead to problems including internal bleeding, liver malfunction or failure, vomiting, diarrhea, dehydration, weight loss, seizures, bloat or kidney failure in at least 3,000 dogs who digested it, according to the lawsuit.

Beneful may also contain mycotoxins, which are toxic byproducts of mold.

“If it’s a hundred or so [dogs], it’s like, ‘Okay, a lot of dogs eat Beneful; things happen,’” Jeff Cereghino, one of Lucido’s attorneys, told The Daily Beast. “But when I look at 4,000? Holy hell, there’s a lot of people out here.”

Nestlé Purina Says Lawsuit is ‘Baseless’

Nestlé Purina Petcare Company issued a dismissive statement in response to the class-action lawsuit.

“We at Beneful want you, our valued customers, to know that this lawsuit is baseless; you can continue to feel confident feeding your dogs our food,” the company stated on its website Feb. 26.

“Adding to the confusion, social media outlets can be a source of false or incomplete information, as many other pet food brands have experienced themselves.”

Keith Schopp, vice president of corporate public relations, said in a statement to The Daily Beast, “We intend to vigorously defend ourselves.”

Photo credit: Jason Meredith

RECALL ALERT: Buster’s Natural Pet Supply Beef Trachea Treats

More than 1,000 Buster’s Natural Pet Supply Beef Trachea Pet Treats sold in two Colorado cities are being voluntarily recalled because they have the potential to be contaminated with Salmonella.

According to a recall notice from the U.S. Food and Drug Administration (FDA), Pet International of Miami is recalling 1,500 units of the product that were sold in retail stores in Conifer and Lakewood, Colo.

The recall was initiated after a routine sampling program of the product, obtained from Buster’s Natural Pet Supply in Conifer, tested positive for Salmonella. The sample was tested by the Colorado Dept. of Agriculture and analyzed by the FDA.

The product sampled had a Buster’s Natural Pet Supply label, but was manufactured by Pet International. Buster’s Natural Pet Supply has recalled the entire product from the two stores in which it is sold. Pet International is investigating what caused the problem.

Salmonella can affect animals as well as people who handle the contaminated treats. The symptoms for both people and animals include nausea, vomiting, diarrhea, abdominal cramping and fever. If you or your pet experiences these symptoms after handling or eating the recalled product, see a doctor or veterinarian.

This recall is limited to 12-pack plastic pouch bags of 6-inch Buster’s Natural Pet Supply Beef Trachea Pet Treats.

  • Lot Code: 8501450
  • UPC Code: 8501450

If you purchased the recalled product, do not feed it to your dog. For a refund, return it with the receipt to the place of purchase. A form will be provided that must be filled out in order to receive a refund. Both the receipt and the completed form are needed for the refund.

Consumers with questions about the recall can call 305-591-3338 Monday through Friday, 9 a.m. to 5 p.m. EST, or email sergioh@petint.com.

Photo: U.S. Food and Drug Administration

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