PANCREATITIS - FDA - NEW DRUGS!

Today I read an article in the magazine "DOGS NATURALLY".

It was all about Pancreatitis in Dogs  and a "New Wonder Drug" that has been given FDA Approval.

My personal feelings may be very different to what you believe or think.

This is one of the reasons "Ted & Co Wellness" was borne. 

I say always look for a safer natural chemical and toxic free option if there is one.

The FDA believe it is acceptable for 4 Dog Deaths out of 17 Dogs in a trial on this new wonder drug. Is this OK to you?

I will let you read the article yourself and you can make your own mind up.

Dogs Naturally Magazine 3rd January 2023 Article on the FDA approved Pancreatitis drug.

 NEW PANCREATITIS DRUG – BUT IS IT SAFE?

Acute pancreatitis in dogs can be a life-threatening disease. Dogs who have acute pancreatitis are usually hospitalized for IV fluid therapy and pain management, as well as medications like anti-nausea drugs and antibiotics if there’s an infection.

The most dangerous part of an acute pancreatitis attack is inflammation of the exocrine cells that make digestive enzymes. Normally they stay within ducts until they reach the small intestine.

But when these cells die, they leak enzymes into the surrounding tissue and start to digest the pancreas’s own tissues. They may even leak into the abdomen. This leads to massive inflammation … and cell death, And it's very painful for your dog!

FDA APPROVES NEW DRUG

The FDA has announced conditional approval for 1 year of the drug PANOQUELL®-CA1. Drugs that address a serious or life-threatening disease can be eligible for conditional approval in cases where it would be difficult to perform effectiveness studies.

The new injectable drug contains the active ingredient fuzapladib sodium. There are always safety concerns with any drug, especially when it’s a new drug that hasn’t been through safety studies.

IS THE NEW DRUG SAFE?

It’s hard to tell, based on the information provided in the FDA’s review. Part of the agency’s approval was based on the fact that the active ingredient has been approved in Japan since 2018.

The FDA approval document cites some studies. One study tested the drug for 3 days. There were 36 dogs …17 who got the drug and 19 in the control group. The researchers measured the dogs’ MCIA scores. MCIA stands for modified canine activity index. The index measures things like activity, appetite, vomiting, cranial abdominal pain, dehydration, stool consistency and blood in stool.

Dogs who received the drug did improve their MCAI slightly more than dogs in the control group.

WHAT ABOUT SIDE EFFECTS?

However, there’s quite a long list of adverse reactions. The most common ones were anorexia, digestive tract disorders, respiratory tract disorders, liver disease, and jaundice. Two dogs experienced cardiac arrest, and 5 dogs died in the study … 4 in the drug group and 1 in the control group (who was euthanized due to poor prognosis).

Can a drug where 4 dogs died (out of 17 that took it for only 3 days) really be considered safe?

Other side effects are facial and tongue swelling, collapse, and seizure, which were reported voluntarily during post-approval monitoring of the drug in dogs “in a foreign market.” These happened within 24 hours of giving the drug.

Another study gave the drug for 9 days to healthy Beagles at various high doses (up to 5 times the labelled dose). There was no systemic toxicity and an “acceptable margin of safety.”  There was some swelling and bruising at the injection site, and some dogs experienced high blood pressure and mild thrombocytopenia (low platelets – platelets help with blood clotting).

WOULD YOU CONSENT TO THE DRUG?

The FDA’s review concluded: “The data demonstrate that PANOQUELL®-CA1, when used according to the label, is safe and has a reasonable expectation of effectiveness for the management of clinical signs associated with acute onset of pancreatitis in dogs.

As a dog owner, would you have confidence in the drug’s safety or efficacy, given the minimal studies done so far? 

Dogs getting this drug will be guinea pigs. The lack of data means “informed consent” isn’t possible.

Acute pancreatitis is a dangerous disease, so it’s possible the drug could turn out to be a life-saving tool that's worth the risks. But let’s hope vets treating dogs will at least give owners an opportunity to approve or refuse this conditionally approved drug.

Whenever you need the emergency vet, it can be near-impossible to have any say in your dog’s treatment. ERs usually whisk the dog away and you don’t have a chance to tell them what you do or don’t want.

But if your dog gets an acute pancreatitis attack, you can at least tell them you’d like to ask the vet in charge of your dog’s treatment about their experience with the drug … and tell them whether you or not you consent to treatment with it. In theory, you have a right to refuse any specific treatment … even though it doesn’t always work that way in practice, especially in emergencies.