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FDA cites Zoetis for false claims for Apoquel...

https://www.fda.gov/media/113909/download?fbclid=IwAR3h0GcykP2VhjPc2v-RGUt2FVcq1C41G08pskKIzNH28d1rQLI8fTbbftw


Zoetis, manufacturer of Apoquel, cited by FDA for making “false or misleading representations about the risks associated with Apoquel”.

Below is a post taken from renowned holistic veterinarian Dr. Will Falconer:

“Vital Animal News: December 22, 2019. By: Will Falconer, DVM

FDA calls out Apoquel's Lies!

Astute Vital Animal Pack member Lorraine Sullivan brought this to my attention after last week’s newsletter.

Have you ever wondered if Apoquel’s claims of safety were legitimate? Well, the US FDA did, and sent a warning letter to its Big Pharma maker with the odd name of Zoetis, Inc. The official letter to the Zoetis vet in charge of “Regulatory Affairs” makes it clear that Apoquel was being promoted with…

"false or misleading representations about the risks associated with APOQUEL." My bet is, if you received a prescription for your itchy allergic dog for this expensive immune suppressing drug, you weren’t told there were safety risks at all. Many of the commenters on my Apoquel expose article, (the most commented upon out of all my blog posts) indicate that no safety warnings were given. The drug was sent home for the dog and now the animal was either suffering from chronic ear inflammation, bladder infection or worse, cancer. Many wrote saying their dog died of cancer after using Apoquel, and a goodly number were young dogs whose age would not be consistent with a high risk of cancer.

Here’s the most damning quote from that FDA letter:

"These claims misleadingly suggest that APOQUEL is safer than steroids without providing comparative studies to support the claim. Moreover, they misleadingly minimize the risk associated with the use of APOQUEL by citing a short term study to support the claim that the side effects are minimal and were similar to placebo when a higher frequency of adverse reactions in Apoquel treated dogs was seen in a longer-term study." It’s worth pointing out that the authors of both the short term study and the long term study were the same authors!

Can you say “cherry picking the data to make more sales?”

If you’d like to review the damning letter, please see Lorraine’s comment here on my Predisposed to Cancer? article. She was kind enough to share the link for you.

And: Buyer Beware! Neither the drug manufacturer nor Dr. WhiteCoat seems to be as concerned about Apoquel’s significant safety issues as they ought to be. That leaves it up to you to watch out for your dog's best interests. Will Falconer, DVM ————

Lorraine Sullivan DECEMBER 15, 2019 AT 9:31 AM I’m not sure if anyone is aware that the FDA sent a letter to Zoetis, makers of Apoquel, regarding the misinformation on their website regarding the safety of this drug. The FDA list the claims made on the website and follow it with- quote: “These claims misleadingly suggest that APOQUEL is safer than steroids without providing comparative studies to support the claim. Moreover, they misleadingly minimize the risk associated with the use of APOQUEL by citing a short term study to support the claim that the side effects are minimal and were similar to placebo when a higher frequency of adverse reactions in Apoquel treated dogs was seen in a longer-term study.” Here is the web address of the 4-page letter: https://www.fda.gov/media/113909/download It is listed in the CVM Untitled Letters as “Zoetis, Inc. Misbranding 2018/05/24 CVM Apoquel (oclacitinib tablet)”.

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