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Is Your Dog Afraid of Things that Go BOOM! in the Night? Two Animal Drugs are FDA-Approved to Help

Is Your Dog Afraid of Things that Go BOOM! in the Night? Two Animal Drugs are FDA-Approved to Help

Does your dog become a quivering ball of fur hiding under your bed at the sound of fireworks? Do you dread Fourth of July and New Year’s Eve because your dog will try to chew and claw his way through the wall to escape? You’re not alone.

Many dogs have what’s called noise aversion, a sensitivity to loud noises that results in signs of anxiety and fear. Two drugs are FDA-approved to treat noise aversion in dogs—Sileo (dexmedetomidine oromucosal gel) and Pexion (imepitoin tablets). Both drugs are available only with a veterinarian’s prescription.


Signs of Noise Aversion in Dogs
Sileo
Pexion
Client Information Sheets
Reporting Problems
Benefits of FDA Approval
More Information


Signs of Noise Aversion in Dogs

Typical signs of anxiety and fear related to noise aversion in dogs are:

  • Panting;
  • Trembling or shaking;
  • Pacing or acting restlessly;
  • Seeking out people;
  • Cowering or hiding;
  • Barking, whining, or howling;
  • Trying to escape, running around, or bolting;
  • Destructive behavior, such as damaging furniture, doors, dog beds, or other nearby items;
  • Freezing in place behavior (being too scared to move);
  • Refusing to eat food or treats;
  • Vomiting or excessive drooling; and
  • Urinating and defecating (having a bowel movement) inappropriately, even though the dog is normally well house-trained.

Both Sileo and Pexion have been shown to lessen the signs of anxiety and fear caused by loud noises such as fireworks, traffic or street noise, and gun shots. However, neither drug has been evaluated for noise aversion caused by thunderstorms.

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Sileo

Sileo is a gel that you place in your dog’s mouth between the cheek and gum so that it can be absorbed into the bloodstream. Your veterinarian or trained veterinary staff will show you how to apply the gel. Sileo’s Client Information Sheet also has pictures and detailed instructions.

You should give the first dose of Sileo to your dog at one of three times:

  • About 30 to 60 minutes before the anticipated noise event;
  • When you detect a noise that typically triggers your dog’s anxiety and fear, such as fireworks; or
  • Immediately after your dog shows the first signs of anxiety and fear related to noise aversion.

It takes about 30 to 60 minutes for Sileo to take effect. Your dog should show less intense signs of noise aversion, despite the ongoing noise. Talk to your veterinarian about how to give Sileo to your dog and how often.

Sileo has not been evaluated in dogs with dental or gingival (gum) disease that could affect the drug’s absorption. Sileo should not be given to dogs with severe heart or breathing problems or to dogs with liver or kidney disease.

Oral Dosing Syringe

Sileo comes as an oral dosing syringe which has a ring-stop mechanism on the plunger that must be “dialed” and locked into place to set the correct dose. You must use this special dosing syringe when giving Sileo to your dog.

Accidental overdose can occur if the ring-stop mechanism is not fully locked. In two years, from May 2016 to May 2018, FDA received over 50 reports of Sileo overdoses in dogs because the ring-stop mechanism was not properly locked at the intended dose. The drug’s label now better emphasizes the need to lock the ring-stop mechanism to prevent overdose. Zoetis, the drug company that markets Sileo, also has training videos on its website to help veterinary staff teach dog owners how to properly handle and give the gel.

Only adults should administer the gel. Wear disposable gloves when giving Sileo, handling the syringe, or touching your dog’s mouth after application so you don’t accidentally get some of the gel on your skin. Throw out the gloves after each use and then wash your hands with soap and water. If you have cuts on your skin or chapped skin, the drug can be absorbed into your body. If you accidentally get some gel on your skin, you should wash the area immediately with lots of water and remove contaminated clothes.

The oral dosing syringe can be used to give more than one dose. You can use a partially-filled syringe within 4 weeks after first opening it, if there’s enough gel for a complete dose for your dog. Store both unopened and opened syringes at room temperature in the original package, as Sileo is sensitive to light.

Side Effects of Sileo in Dogs

Possible side effects of Sileo in dogs include:

  • Vomiting;
  • Diarrhea;
  • Sedation;
  • Decreased heart rate;
  • Decreased breathing rate; and
  • Pale gums.
Warnings for People about Sileo

Avoid giving Sileo if you’re pregnant, as exposure may cause uterine contractions, decreased fetal blood pressure, or both.

Sileo can be absorbed into your body through your eyes, nose, or mouth. If the drug comes into contact with your eyes, nose, or mouth, flush with water for 15 minutes.

If you’re accidentally exposed to Sileo, your blood pressure may drop. Symptoms of low blood pressure include dizziness; fainting; lack of concentration; blurred vision; nausea; cold, clammy or pale skin; and rapid, shallow breathing. You may also feel sleepy or sedated and have a slow heart rate. Contact your healthcare provider immediately and bring the package information to your appointment. Tell your healthcare provider that Sileo is an alpha-2 adrenoceptor agonist. Read Sileo’s Client Information Sheet for more information.

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Pexion

Pexion is an oral tablet that you give to your dog by mouth twice a day, about 12 hours apart, starting two days before an expected noise event and continuing throughout the event. For example, you would start giving Pexion to your dog two days before New Year’s Eve and continue giving it until the fireworks celebration ends. It may take anywhere from two hours to two days after the first dose for the drug to take effect. Talk to your veterinarian about how to give Pexion to your dog and how often. Pexion’s Client Information Sheet also has detailed instructions.

Side Effects of Pexion in Dogs

Possible side effects of Pexion in dogs include:

  • Difficulty standing and walking and having a wobbly gait (in most dogs, this lessens or goes away by the next day without needing to stop the drug);
  • Increased appetite;
  • Decreased activity level; and
  • Vomiting.

Most side effects start within the first 4 hours after the first dose and go away within 12 to 48 hours without needing to stop the drug.

Certain drugs used to treat anxiety-related disorders, such as Pexion, can lower a dog’s normal self-control. This may cause some dogs to become aggressive when they otherwise wouldn’t. Watch your dog carefully while he is on Pexion. Call your veterinarian if you’re concerned about your dog’s behavior.

Warnings for People about Pexion

If you accidentally ingest Pexion, contact your healthcare provider and bring the package information to your appointment. Tell your healthcare provider that Pexion is a GABAA receptor partial agonist. Read Pexion’s Client Information Sheet for more information.

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Client Information Sheets

Both Sileo and Pexion have a Client Information Sheet. Your veterinarian should give you this sheet every time you receive a prescription for Sileo or Pexion, whether it’s the first time your dog is receiving the drug or it’s the 15th refill. The Client Information Sheet is written specifically for dog owners, in a user-friendly, question-and-answer format. The handout gives you detailed information about the drug and its side effects, helping you use the drug as safely and effectively as possible in your dog.

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Reporting Problems

FDA encourages you to call your veterinarian if you think your dog is experiencing a side effect from Sileo or Pexion. A side effect associated with a drug is called an adverse drug experience. Adverse drug experiences also include a lack of effect (the drug doesn’t do what it’s expected to do) and reactions in people who handle the drug. Call your healthcare provider if you have a reaction to Sileo or Pexion.

FDA also encourages you to work with your veterinarian to report any adverse drug experience—in either pets or people—associated with Sileo or Pexion. How to report animal drug side effects and product problems.

Remember to keep Sileo and Pexion in a secure location out of reach of children, dogs, cats, and other animals to prevent accidental ingestion or overdose.

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Benefit of FDA Approval

Knowing a drug is safe, effective, and high-quality is the benefit of FDA approval. During the approval process for an animal drug, the agency evaluates information submitted by the drug company to make sure the drug is safe and effective for its intended use and that the drug is properly manufactured and properly labeled.

FDA-approved Sileo and Pexion have both been shown to be safe and effective in dogs when used according to the directions on the label. Both drugs are properly manufactured and properly labeled, and each drug’s label provides dosing and safety information specific to dogs.

If your dog needs medication to treat noise aversion, talk to your veterinarian about which FDA-approved drug—Sileo or Pexion—is best for your dog.

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For More Information

See Animal Drugs @ FDA for more information about Sileo and Pexion.

Contact FDA’s Center for Veterinary Medicine at either AskCVM@fda.hhs.gov or 240-402-7002

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