On June 29, 2018, the FDA updated it's warning regarding the noise aversion drug, Sileo, from Zoetis.  Please keep your pets inside during the 4th of July and during thunderstorms. While you may enjoy the fireworks, you don't know how your pet will react. It is always better to be safe.

If you've been following our blog, you know that we use natural and holistic methods with not only ourselves, but our pets. 

Thankfully, there are essential oils to help support your dog during these noisy times. We have been using them over the past 4 holidays and during thunderstorms. While the thunderstorms are rare in AZ, we still have them during monsoon. 

We do a 4 step approach -

First, we grab our diffuser and get that bubbling with 2 drops each of T-Away essential oil, Lavender essential oil and Ylang Ylang essential oil. If we're out of T-Away as it can be seasonal, we'll use 2 drops of Peace & Calming essential oil instead. 

Second, turn on some soothing music and turn it up semi-loud. If there's a lot going on in the house, we will put them in one room.

Third, we turn down the lights, not off, but just not bright.

Fourth, we will dilute lavender with water and gently pet our dogs along their backs. If it's really loud, we'll also add some T-Away or Peace & Calming as extra support.

We only use and recommend Young Living essential oils. If you are interested in purchasing essential oils and a diffuser, please visit our website. You can get an Essential Oils Premium Starter Bundle that will come with the diffuser or your choice and 11 5ml bottles of essential oils along with samples of other products. The 5ml bottles contain approximately 85 drops of oil and that goes a long way.

We have not used a Thundershirt because our dogs do not like clothes. I know people that use them but for us, it would cause more stress just putting it on.

Updated: From May 2016, when Zoetis began marketing Sileo, to May 16, 2018, the FDA has received a total of 54 adverse event reports involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose. In the year since the FDA published its original Animal Drug Safety Communication on this issue, the agency has received 26 additional reports of accidental Sileo overdoses in dogs.

The FDA is reissuing this advisory because adverse events are continuing to occur. The agency continues to advise veterinarians to carefully educate owners and handlers how to properly use the syringe to avoid accidental overdosing.

In 2017, after becoming aware of the adverse events related to ring-stop locking issues, the FDA asked Zoetis to revise its labeling to better emphasize the need to secure the ring-stop mechanism to prevent overdose. This revised labeling is now in use. Zoetis has also provided enhanced training videos on its website to help veterinarians teach owners and handlers how to properly handle and administer Sileo.

May 23, 2017

The U.S. Food and Drug Administration is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo. Sileo is a prescription gel that is given to dogs by mouth to treat noise aversion (signs related to anxiety or fear due to noise).

Sileo is packaged in an oral dosing syringe with a ring-stop mechanism on the plunger that must be “dialed” and locked into place in order to set the correct dose for the dog. Overdose can result if the ring-stop is not fully locked. Therefore, it is very important that the person administering the product understands how to operate the syringe correctly before giving the product to the dog.

Some dogs have experienced clinical signs of overdose, including lethargy, sedation, sleepiness, slow heart rate, loss of consciousness, shallow or slow breathing, trouble breathing, impaired balance or incoordination, low blood pressure, and muscle tremors. No deaths have been reported. At this time, the FDA has not determined if these overdoses were due to improper use of the ring-stop.

All prescribing veterinarians and users should be aware of the possibility for accidental overdose if the Sileo syringe is not properly locked before dosing. Veterinary staffs are strongly encouraged to provide education in proper operation of the syringe to dog owners before dispensing the drug. Dog owners should be aware of potential signs of overdose and they should contact their veterinarian if their dog exhibits any of these signs. Zoetis has also provided online resources which demonstrate the proper operation of the syringe and administration technique in detail for veterinarians at Sileodvmus.com, and for dog owners at Sileodogus.com.

FDA original article - 6/29/18